The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials
Open accessAbstract
BACKGROUND: There is a concern in the literature that harm from interventions is insufficiently documented in clinical trials in general, and in those assessing psychological treatments in particular. A recent decision by a trial steering committee to stop recruitment into a randomized controlled trial (RCT) of a psychological intervention for personality disorder led to an investigation of the recording of harm in trials funded by the National Institute for Health Research (NIHR). METHODS: The protocols and final reports of all 82 NIHR trials funded between 1995 and 2013 were examined for the reporting of adverse events. These were subdivided by category of intervention. RESULTS: None of the psychological intervention trials mentioned the occurrence of an adverse event in their final report. Trials of drug treatments were more likely to mention adverse events in their protocols compared with those using psychological treatments. When adverse events were mentioned, the protocols of psychological interventions relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES), which were developed for drug rather than psychological interventions and so may not be appropriate for the latter. CONCLUSIONS: This survey supported the belief that the reporting of adverse events in psychological treatments is weak and the criteria used may not be appropriate. Recommendations are made as to how current practice might be improved.
AI snapshot
Written from the paper’s full text.
TL;DR
In a review of 82 NIHR-funded trials, psychological intervention trials were far less likely than drug trials to specify or report adverse events, and none of the completed psychological trials mentioned adverse events in final reports. When psychological protocols did mention adverse events, they largely used NRES severe-adverse-event categories developed for drug trials, which may not fit psychological interventions.
Key findings
- None of the psychological intervention trials mentioned the occurrence of an adverse event in their final report; in completed studies using a psychological intervention, there was no mention of an adverse event in any of the 14 completed studies.
- Drug trials were more likely to mention adverse events in protocols than psychological trials: in incomplete studies with protocols only, 8/8 drug protocols (100%) and 2/2 combined protocols (100%) mentioned adverse events, compared with 17/28 psychological protocols (61%).
- When psychological protocols listed adverse events, they relied heavily on NRES severe-adverse-event definitions: death in 65%, hospitalization in 56%, persistent disability in 43%, and congenital abnormality or birth defect in 39%; events more relevant to psychological therapy, such as self-harm, symptom change, distress, or Accident & Emergency attendance, were mentioned in only a few trials.
- No trial was found to have been discontinued because of adverse event reports prior to the PEPS trial, and none of the trials using a psychological treatment were stopped because of an adverse event differential.
Methods
- Retrospective documentary review of protocols and final reports from all 82 NIHR trials funded between August 1995 and October 2013, subdivided into psychological only, drug only, combined psychological and drug, and other interventions.
- Trials were categorized as completed with protocol, completed without protocol, incomplete with protocol only, or incomplete in editorial with protocol only; 44 interventions were psychological, 14 drug, 5 combined, and 19 other.
- The first author manually searched the reports and extracted any information on adverse events from protocols and/or final reports where available, summarized descriptively by intervention type and trial status.
Limitations
- The paper states that small numbers of trials in each group make it difficult to be confident that differences between psychological and pharmacological trials, or between earlier and later protocols, are robust; earlier trials often lacked accessible protocols because the funding agency did not insist on them.
- Evident from the text: adverse event information was extracted manually by the first author, and many incomplete trials had only protocols available, so final-report reporting could not be assessed for those trials.
- Evident from the text: the review reports descriptive counts and percentages without formal statistical testing of the differences between intervention categories.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 34 cited sources checked · 0 supported · 0 flagged
- Findingown data
To the authors' knowledge, the PEPS trial was the first UK trial of a psychological therapy to have recruitment stopped on the grounds of adverse events.
“To our knowledge, this was the first time recruitment to a UK trial of a psychological therapy had been stopped on the grounds of adverse events.”
- Also stated in: § Completed studies · plain
“We found no evidence of a trial having been discontinued because of adverse event reports prior to PEPS.”
Quote in the paperSubstantial claim - Also stated in: § Completed studies · plain
- Findingown data
None of the trials using a psychological treatment were stopped because of an adverse event differential.
“Specifically, none of the trials using a psychological treatment were stopped because of an adverse event differential.”
Quote in the paperSubstantial claim - Findingown data
None of the psychological intervention trials mentioned the occurrence of an adverse event in their final report.
“None of the psychological intervention trials mentioned the occurrence of an adverse event in their final report.”
- Also stated in: § Completed studies · plain
“In none of the 14 completed studies using a psychological intervention was there a mention of an adverse event.”
Quote in the paperSubstantial claim - Also stated in: § Completed studies · plain
- Findingown data
There was some reporting of adverse events in the final reports of each of the non-psychological intervention categories (drug, combined, other).
“Conversely, there was some reporting of adverse events in the final reports of each of the other categories.”
Quote in the paperSubstantial claim - Findingown data
Trials of drug treatments were more likely to mention adverse events in their protocols compared with trials using psychological treatments.
“Trials of drug treatments were more likely to mention adverse events in their protocols compared with those using psychological treatments.”
Quote in the paperSubstantial claim
- Findingown data
Protocols of psychological interventions that mentioned adverse events relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES).
“the protocols of psychological interventions relied heavily on severe adverse events guidelines from the National Research Ethics Service (NRES)”
Quote in the paperSubstantial claim - Findingown data
In more recently funded psychological studies, adverse events were more likely to be mentioned in their protocols.
“We noted, however, that in the more recently funded psychological studies that adverse events were more likely to be mentioned in their protocols.”
Quote in the paperSubstantial claim - Findingown data
Psychological interventions were less likely to list adverse events in their protocols compared with drug trials.
“and were less likely to list adverse events in their protocols compared with drug trials”
Quote in the paperSubstantial claim - Findingown data
Other events relevant for psychological therapies (such as self-harm, symptom change, distress or attendance at A&E) were mentioned in only a few trials.
“for psychological therapies (such as self-harm, symptom change, distress or attendance at Accident & Emergency departments) were mentioned in only a few trials.”
Quote in the paperSubstantial claim - Findingown data
When adverse events were reported in protocols of psychological interventions, there was reliance on NRES definitions of severe adverse events.
“Alternatively, when adverse events were reported there was a reliance on the definitions of severe adverse events from the safety reporting guidelines from the National Research Ethics Service (NRES).”
Quote in the paperSubstantial claim - Findingown data
None of the psychological interventions mentioned adverse events in their final reports.
“In summary, none of the psychological interventions mentioned adverse events in their final reports”
Quote in the paperSubstantial claim - Findingown data
In the incomplete trials and those at the editorial stage, drug interventions (together with drug and psychological interventions combined) mentioned adverse events in all 9 protocols examined.
“In contrast, drug interventions (together with drug and psychological interventions combined) mentioned adverse events in all of the 9 protocols examined.”
Quote in the paperSubstantial claim - Findingown data
In the incomplete trials and those at the editorial stage, psychological interventions mentioned adverse events in 17 of 30 trial protocols (56%).
“In the incomplete trials and those at the editorial stage, we found that psychological interventions (55% of the total) mentioned adverse events in 17 of the 30 trial protocols (56%).”
Quote in the paperSubstantial claim - Findingown data
The difference in listing adverse events in protocols between psychological and drug trials is changing with more recently funded psychological trials at least mentioning adverse events in their protocol.
“but this difference is changing with the more recently funded psychological trials at least mentioning adverse events in their protocol.”
Quote in the paperSubstantial claim - Findingown data
The failure to specify, record and report adverse events during psychological therapy was confirmed by our examination of 91 NIHR-funded trials.
“The failure to specify, record and report adverse events during psychological therapy was confirmed by our examination of 91 NIHR-funded trials.”
Quote in the paperSubstantial claim- Rests on an assumption: Adverse events would be expected to be routinely recorded and reported in well-conducted randomized controlled trials.
- Findingown data
Our examination of the literature suggests that adverse events are not being adequately reported.
“However, our examination of the literature suggests that unfortunately such events are not being adequately reported.”
Quote in the paperSubstantial claim- Rests on an assumption: Adverse events would be expected to be routinely recorded and reported in well-conducted randomized controlled trials.
- Findingown data
There was little evidence of thought being given to which adverse event might be likely to arise from a specific intervention in a particular population.
“There was little evidence of thought being given to which adverse event might be likely to arise from a specific intervention in a particular population.”
Quote in the paperSubstantial claim - Findingown data
The 17 psychological trial protocols that mentioned adverse events used the definitions of adverse events suggested by NRES, for example death, hospitalization or persistent disability.
“but used the definitions of adverse events suggested by the NRES, for example death, hospitalization or persistent disability.”
Quote in the paperSubstantial claim - Findingown data
Of the 37 psychological trial protocols examined, 17 (46%) did mention adverse events.
“Of the 37 psychological trial protocols examined, 17 (46%) did mention adverse events”
Quote in the paperSubstantial claim - Findingnone given
The 2004 revision of the CONSORT recommendations on harm monitoring seems to have had little impact in our study sample.
“For example, the 2004 revision of the CONSORT recommendations on harm monitoring seems to have had little impact in our study sample.”
Quote in the paperNot a substantial claim - Findingnone given
The types of adverse events described are strongly influenced by categories from the NRES safety reporting standards.
“the types of adverse events described are strongly influenced by categories from the NRES safety reporting standards”
Quote in the paperSubstantial claim - Findingnone given
The situation is improving with more recently funded psychological trials mentioning adverse events in their protocol.
“Although this situation is improving with more recently funded psychological trials mentioning adverse events in their protocol”
Quote in the paperSubstantial claim- Rests on an assumption: Adverse events would be expected to be routinely recorded and reported in well-conducted randomized controlled trials.
- Findingown data
Those involved in trialing psychological interventions gave less attention to the reporting of adverse events compared with trials of other types of interventions and especially with drug interventions.
“We found that those involved in trialing psychological interventions gave less attention to the reporting of adverse events compared with trials of other types of interventions and especially with drug interventions.”
Quote in the paperSubstantial claim- Rests on an assumption: Adverse events would be expected to be routinely recorded and reported in well-conducted randomized controlled trials.
- Interpretationreasoning
The NRES severe adverse events guidelines may not be appropriate for psychological interventions.
“which were developed for drug rather than psychological interventions and so may not be appropriate for the latter.”
- Also stated in: § Conclusions · hedged
“the criteria used may not be appropriate.”
Quote in the paperSubstantial claim- Rests on an assumption: The NRES severe adverse events guidelines were developed for drug rather than psychological interventions.
- Also stated in: § Conclusions · hedged
- Premisecitation
The Data Monitoring Committee of the PEPS trial noted higher rates of mental health-related adverse events (overdose, self-harm and suicide attempts) among those in the active arm of the intervention.
“the Data Monitoring Committee (DMC) of a publicly funded trial of a psychoeducation with problem-solving (PEPS) intervention for community-dwelling adults with personality disorder [1] noted higher rates of adverse events (AEs), specifically mental health-related adverse events (overdose, self-harm and suicide attempts), among those in the active arm of the intervention.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1] McMurran M, Crawford MJ, Reilly JG, McCrone P, Moran P, Williams H, Adams CE, Duggan C, Delport J, Whitham D, Day F: Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: a pragmatic multi-site community-based randomized clinical trial. Trials. 2011, 12: 198- source
Not checked in the free run.
- Interpretationown data
The survey supported the belief that the reporting of adverse events in psychological treatments is weak.
“This survey supported the belief that the reporting of adverse events in psychological treatments is weak”
Quote in the paperSubstantial claim - Premisecitation
The recognition that the reporting of harms in randomized controlled trials is unsatisfactory led the CONSORT group to suggest 10 new recommendations in the reporting of harms.
“The recognition that the reporting of harms in randomized controlled trials is unsatisfactory led to the CONSORT group suggesting 10 new recommendations in the reporting of harms [16].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [16] Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D: Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004, 141: 781-788. source
Not checked in the free run.
- Premisecitation
None of the studies for borderline personality disorder mentioned adverse events.
“and Stoffers et al. [22] found none for BPD.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [22] Stoffers JM, Völlm BA, Rücker G, Timmer A, Huband N, Lieb K: Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2012, Art. No (8): CD005652-doi:10.1002/14651858.CD005652.pub2
Not checked in the free run.
- Premisecitation
Of 39 trials for antisocial and borderline personality disorder, only one out of 11 studies mentioned adverse events for antisocial personality disorder.
“Of 39 trials for antisocial (ASPD) and borderline personality disorder (BPD), Gibbon et al. [21] found only one out of 11 studies mentioned adverse events for ASPD”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21] Gibbon S, Duggan C, Stoffers J, Huband N, Völlm BA, Ferriter M, Lieb K: Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2010, 6: CD007668-
Not checked in the free run.
- Interpretationcitation
The range of outcomes and the long time frame of the Cambridge Somerville Youth Trial strongly indicate that those in the active arm had suffered sustained harm.
“The range of outcomes and the long time frame strongly indicate that those in the active arm of the trial had suffered sustained harm.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [13] McCord J: Cures that harm: unanticipated outcomes of crime prevention programs. Ann Am Acad Pol Soc Sci. 2003, 587: 16-30. source
Not checked in the free run.
- Interpretationreasoning
An intervention may be effective overall but be harmful to a minority.
“Thus, an intervention may be effective overall but be harmful to a minority.”
Quote in the paperSubstantial claim - Interpretationreasoning
It is difficult to be sure why harm has occurred, even when harm has been established.
“This highlights one of the major problems in this area, namely, that it is difficult to be sure why harm has occurred, even when harm has been established.”
Quote in the paperSubstantial claim - Premisecitation
The cause of the adverse outcome in the Cambridge Somerville Youth Trial has proved elusive.
“the cause of this adverse outcome has proved to be elusive [15].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [15] McCord GS: Forward to crime and family: selected essays of Joan McCord. Crime and Family: Selected Essays of Joan McCord. Edited by: McCord GS. 2007, Philadelphia: Temple University Press
Not checked in the free run.
- Interpretationnone given
It is probably impossible in an individual case to distinguish whether harm was caused by the intervention or was part of the natural course of the disorder or due to life events.
“While the distinction between harm being caused by the intervention or being part of the natural course of the disorder or due to life events is probably impossible in an individual case”
Quote in the paperNot a substantial claim - Interpretationreasoning
RCTs offer an opportunity to identify and thereby avoid using interventions that might be harmful.
“They therefore offer an opportunity, not only to identify and thereby avoid using interventions that might be harmful, but also to provide information about possible mechanisms whereby psychological interventions can effect change.”
Quote in the paperSubstantial claim - Premisecitation
RCT design allows one to draw causal inferences between an intervention and any harmful outcome.
“and their design allows one to draw causal inferences between an intervention and any harmful outcome [8].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [8] Dimidjian S, Hollon SD: How would we know if psychotherapy were harmful?. Am Psychol. 2010, 65: 21-33. source
Not checked in the free run.
- Interpretationreasoning
RCTs offer an opportunity to provide information about possible mechanisms whereby psychological interventions can effect change.
“They therefore offer an opportunity, not only to identify and thereby avoid using interventions that might be harmful, but also to provide information about possible mechanisms whereby psychological interventions can effect change.”
Quote in the paperNot a substantial claim - Premisecitation
Randomized controlled trials provide the best opportunity to examine the recording of adverse events because data are more likely to be systematically recorded compared with routine clinical practice.
“Randomized controlled trials provide the best opportunity to examine the recording of adverse events as data are more likely to be systematically recorded compared with routine clinical practice”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [8] Dimidjian S, Hollon SD: How would we know if psychotherapy were harmful?. Am Psychol. 2010, 65: 21-33. source
Not checked in the free run.
- Interpretationreasoning
Current practice does not allow one to distinguish between the alternatives for absence of reporting.
“Current practice, regrettably, does not allow one to distinguish between these alternatives.”
Quote in the paperSubstantial claim - Premisecitation
There is substantial evidence that some patients may be harmed by psychological therapy.
“There is substantial evidence that some patients may be harmed by psychological therapy, although the prevalence and causes of harm have been inadequately researched ( [24], p. 206).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24] Lambert MJ: The efficacy and effectiveness of psychotherapy. Chapter 6. Bergin & Garfield’s Handbook of Psychotherapy and Behavior Change Sixth Edition. Edited by: Lambert MJ. 2013, New Jersey: Wiley
Not checked in the free run.
- Interpretationown data
Despite these limitations, there is considerable room for improvement in specifying, recording and reporting adverse events in NIHR-funded clinical trials of psychological interventions.
“Despite these limitations, it is clear that there is considerable room for improvement in specifying, recording and reporting adverse events in NIHR-funded clinical trials of psychological interventions.”
Quote in the paperSubstantial claim- Rests on an assumption: Adverse events would be expected to be routinely recorded and reported in well-conducted randomized controlled trials.
- Study design and conductown data
The small numbers of trials in each group make it difficult to be confident that the differences found between psychological and pharmacological trials, or between earlier and later protocols, are robust.
“First, the small numbers of trials in each group make it difficult to be confident that the differences found between psychological and pharmacological trials, or between earlier and later protocols, are robust.”
Quote in the paperSubstantial claim - Interpretationreasoning
If the reporting of negative outcomes and adverse events in trials were improved, meta-analysis would enable robust conclusions to be drawn about the risks and benefits of psychological therapies.
“If the reporting of negative outcomes and adverse events in trials were improved, meta-analysis would enable robust conclusions to be drawn about the risks and benefits of psychological therapies”
Quote in the paperNot a substantial claim - Premisereasoning
Only a properly randomized comparison allows conclusions to be drawn about the relative rates of adverse effects and adverse events between interventions, as well as their relative efficacy.
“only a properly randomized comparison allows conclusions to be drawn about the relative rates of adverse effects and adverse events between interventions, as well as their relative efficacy.”
Quote in the paperSubstantial claim - Premisecitation
Clinical trials provide the most internally valid estimates of harmful effects.
“While clinical trials are difficult to carry out, their design provides the most internally valid estimates of harmful effects [8].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [8] Dimidjian S, Hollon SD: How would we know if psychotherapy were harmful?. Am Psychol. 2010, 65: 21-33. source
Not checked in the free run.
- Interpretationreasoning
NRES safety reporting standards have limited applicability for psychological interventions.
“which have limited applicability for psychological interventions.”
Quote in the paperSubstantial claim
- May combine two claims. 19
- Classified as probably not a substantial claim. 18
May combine two claims.
Findingown dataOf the 82 NIHR-funded trials examined, 44 interventions were psychological, 14 involved drugs, 5 were a combination of drugs and a psychological intervention, and 19 were other.
“A total of 44 of the interventions were psychological, 14 involved drugs, 5 were a combination of drugs and a psychological intervention and 19 were other (see Table 1).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIn protocols of psychological interventions, some did not consider adverse events at all or dismissed the likelihood of their occurrence.
“The first was for these not to be considered at all, or for the likelihood of their occurrence to be dismissed.”
Quote in the paperSubstantial claimMay combine two claims.
FindingreasoningWhen adverse events are listed in protocols of psychological interventions, NRES influence is seen: death occurring in 65%, hospitalization in 56%, persistent disability in 43%, and congenital abnormality or birth defect in 39%.
“When adverse events are listed in the protocols of psychological interventions, one can see the influence of NRES, with death occurring in 65%, hospitalization in 56%, persistent disability in 43%, and congenital abnormality or birth defect in 39%.”
Quote in the paperSubstantial claimMay combine two claims.
FindingreasoningThere was evidence of improvements over time, with more recent trials more likely to specify adverse events in protocols.
“There was evidence of improvements over time, with more recent trials more likely to specify adverse events in protocols.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn rheumatoid arthritis and osteoarthritis, withdrawals due to adverse events and severity were more frequent in pharmacological compared with non-pharmacological treatments.
“Ethgen et al. [19] showed that in the reporting of harms, withdrawals due to adverse events and severity were more frequent in pharmacological compared with non-pharmacological treatments in rheumatoid arthritis and osteoarthritis.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [19] Ethgen M, Boutron I, Baron G, Giraudeau B, Sibilia J, Ravaud P: Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease. Ann Intern Med. 2005, 143: 20-25. source
Not checked in the free run.
May combine two claims.
PremisecitationIn mental health trials, reporting of harm in drug trials was adequate in only 21.4% of the trials reviewed, but none of the non-drug trials had adequate reporting of clinical adverse events.
“In mental health, the reporting of harm in drug trials was adequate in only 21.4% of the trials reviewed but none of the non-drug trials had adequate reporting of clinical adverse events [20].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20] Papanikolaou PN, Churchill R, Wahlbeck K, Ioannidis JP: Safety reporting in randomized trials of mental health interventions. Am J Psychiatry. 2004, 161: 1692-1697. source
Not checked in the free run.
May combine two claims.
PremisecitationThe Trial Steering Committee of the PEPS trial were unable to rule out the possibility that the intervention was instrumental in the excess of adverse events and issued an instruction to stop recruitment into the trial.
“The TSC were unable to rule out the possibility that the intervention was instrumental in the excess of AEs and so the TSC issued an instruction to stop recruitment into the trial.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [1] McMurran M, Crawford MJ, Reilly JG, McCrone P, Moran P, Williams H, Adams CE, Duggan C, Delport J, Whitham D, Day F: Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: a pragmatic multi-site community-based randomized clinical trial. Trials. 2011, 12: 198- source
Not checked in the free run.
May combine two claims.
PremisecitationIn the PEPS trial, the Trial Steering Committee recommended that recruitment and treatment of participants should cease due to the excess number of adverse events relating to mental health in the active treatment arm, although the trial should continue to collect follow-up data on all of those who had already completed treatment.
“In the PEPS trial, the TSC recommended that recruitment and treatment of participants should cease due to the excess number of adverse events relating to mental health in the active treatment arm of the trial, although the trial should continue to collect follow-up data on all of those who had already completed treatment.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [1] McMurran M, Crawford MJ, Reilly JG, McCrone P, Moran P, Williams H, Adams CE, Duggan C, Delport J, Whitham D, Day F: Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: a pragmatic multi-site community-based randomized clinical trial. Trials. 2011, 12: 198- source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThere is a different threshold for stopping a trial in the case of potential harm than in the case of benefit.
“However, these decisions are rarely straightforward, and there is a different threshold for stopping a trial in the case of potential harm than in the case of benefit [17].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] Pocock SJ: When to stop a clinical trial. Br Med J. 1992, 305: 235-240. source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationOnly 21% of randomized controlled trials of psychological intervention had information suggesting that harm was monitored.
“Jonsson et al. [23], in a recent review, reported that only 21% of randomized controlled trials of psychological intervention had information suggesting that harm was monitored.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23] Jonsson U, Alaie I, Parling T, Arnberg FK: Reporting of harms in randomized controlled trials of psychological interventions for mental and behavioural disorders: a review of current practice. Contemp Clin Trials. 2014, 38: 1-8. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationThe reasons for dropping out of treatment are heterogeneous and some reviews have considered drop out as an adverse event.
“The reasons for dropping out are heterogeneous and some reviews have considered drop out as an adverse event [18].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] Jones C, Hacker D, Cormac I, Meaden A, Irving CB: Cognitive behavioural therapy versus other psychosocial treatments for schizophrenia. Cochrane Database Syst Rev. 2012, Art. No (4): CD008712-Doi: 10.1002/14651858.CD008712.pub2
Not checked in the free run.
May combine two claims.
InterpretationcitationThere remain inadequacies of adverse event reporting in non-pharmacological interventions in general and particularly in mental health trials.
“Despite these injunctions, there remain inadequacies of adverse event reporting in non-pharmacological interventions in general and particularly in mental health trials.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [19] Ethgen M, Boutron I, Baron G, Giraudeau B, Sibilia J, Ravaud P: Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease. Ann Intern Med. 2005, 143: 20-25. source
Not checked in the free run.
- cites [20] Papanikolaou PN, Churchill R, Wahlbeck K, Ioannidis JP: Safety reporting in randomized trials of mental health interventions. Am J Psychiatry. 2004, 161: 1692-1697. source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationThe fact that deterioration has to be sustained addresses the concern that some temporary discomfort is often a necessary part of the process of psychological change.
“The fact that the deterioration has to be sustained addresses the concern that some temporary discomfort is often a necessary part of the process of psychological change [9].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [9] Crown S: Contraindications and dangers of psychotherapy. Br J Psychiatry. 1983, 148: 468-470.
Not checked in the free run.
May combine two claims.
PremisecitationRelaxation treatment may be helpful to some who suffer from panic attacks, but for others its focus on interoceptive stimuli can precipitate attacks.
“For instance, it is recognized that while relaxation treatment may be helpful to some who suffer from panic attacks, for others, its focus on interoceptive stimuli can have the effect of precipitating attacks [11].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [11] Adler CM, Craske MG, Barlow DH: Relaxation-induced panic (RIP): when resting isn’t peaceful. Integr Psychiatry. 1987, 5: 94-100.
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn psychological treatments, the competence and natural attributes of the therapist assume greater importance compared to those of a practitioner prescribing a drug.
“This is especially important for psychological treatments where the competence and natural attributes of the therapist assume greater importance compared to those of a practitioner prescribing a drug [10].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [10] Norrie I, Davidson K, Tata P, Gumley A: Influence of therapist competence and quantity of CBT on suicide behavious and in patient hospitalization in a randomized controlled trial in borderline personality disorder: further analysis of treatment effects in the BOSCOT study. Psychol Psychother Theory Res Pract. 2013, 86: 280-293. source
Not checked in the free run.
May combine two claims.
PremisecitationIn the Cambridge Somerville Youth Trial, while there was no benefit from active treatment in 59% of matched pairs, in the 41% where there were differences, those with worse outcomes across a range of measures had been in the active treatment condition.
“When those in the trial were followed up 30 years after its completion, it was found that while there was no benefit from the active treatment in 59% of the matched pairs, in the 41% where there were differences, those with the worse outcomes across a range of measures had been in the active treatment condition [13].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [13] McCord J: Cures that harm: unanticipated outcomes of crime prevention programs. Ann Am Acad Pol Soc Sci. 2003, 587: 16-30. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisereasoningThe design of a randomized trial permits consideration of whether harm is caused by the intervention when there is a differential effect between the trial and the control condition.
“the design of a randomized trial permits consideration of this possibility when there is a differential effect between the trial and the control condition.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationIn Horigian et al.'s trial of family therapy for drug abusing adolescents, they did not consider an increase in drug use to be an adverse event, arguing that drug use among adolescents is so erratic that any increased usage would be difficult to measure.
“In their trial of family therapy for drug abusing adolescents, for instance, they did not consider an increase in drug use to be an adverse event, arguing that drug use among adolescents is so erratic that any increased usage would be difficult to measure.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [26] Horigian VE, Robbins MS, Dominquez R, Ucha J, Rosa CL: Principles for defining adverse events in behavioural intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010, 7: 58-68. source
Not checked in the free run.
Classified as probably not a substantial claim. May combine two claims.
Interpretationnone givenThe absence of reporting could mean that no adverse event occurred (a zero event), that it occurred but was either not recognized or recorded, or that it was recorded but not reported.
“This absence of reporting could mean that no adverse event occurred (a zero event), that it occurred but it was either not recognized or recorded, and finally, that it was recorded but not reported.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationThe prevalence and causes of harm from psychological therapy have been inadequately researched.
“There is substantial evidence that some patients may be harmed by psychological therapy, although the prevalence and causes of harm have been inadequately researched ( [24], p. 206).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24] Lambert MJ: The efficacy and effectiveness of psychotherapy. Chapter 6. Bergin & Garfield’s Handbook of Psychotherapy and Behavior Change Sixth Edition. Edited by: Lambert MJ. 2013, New Jersey: Wiley
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationPeople with borderline personality disorders may be at increased risk of negative outcomes from psychological therapy.
“For example, people with borderline personality disorders may be at increased risk of negative outcomes from psychological therapy [25]”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] Mohr D: Negative outcome in psychotherapy: a critical review. Clin Psychol Sci Pract. 1995, 2: 1-27. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn Horigian et al.'s trial, only when increased drug use resulted in hospitalization was it categorized as a severe adverse event.
“Hence, it was only when such increased drug use resulted in hospitalization that it was categorized as a severe adverse event.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [26] Horigian VE, Robbins MS, Dominquez R, Ucha J, Rosa CL: Principles for defining adverse events in behavioural intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010, 7: 58-68. source
Not checked in the free run.
May combine two claims.
PremisecitationHorigian et al. found that only 30% of adverse incidents were spontaneously reported to research assistants, but this increased to 70% when structured interviews were used.
“Horigian et al. [26] found that only 30% of adverse incidents were spontaneously reported to research assistants, but this increased to 70% when structured interviews were used.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] Horigian VE, Robbins MS, Dominquez R, Ucha J, Rosa CL: Principles for defining adverse events in behavioural intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010, 7: 58-68. source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
PremisecitationVisual inspection of the outliers in the fourth quartile may identify those at risk of being harmed by the intervention.
“At an individual level, visual inspection of the outliers in the fourth quartile may identify those at risk of being harmed by the intervention [8].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [8] Dimidjian S, Hollon SD: How would we know if psychotherapy were harmful?. Am Psychol. 2010, 65: 21-33. source
Not checked in the free run.
Classified as probably not a substantial claim. May combine two claims.
PremisecitationOnly some adverse events are spontaneously reported, and accurate assessment requires systematic monitoring, with the use of structured interviews and records from other agencies.
“Horigian et al. [26] also highlight a further issue which requires attention: only some adverse events are spontaneously reported, and accurate assessment requires systematic monitoring, with the use of structured interviews and records from other agencies.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] Horigian VE, Robbins MS, Dominquez R, Ucha J, Rosa CL: Principles for defining adverse events in behavioural intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010, 7: 58-68. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationHorigian et al. recommended systematic monitoring so that general and specific questions that target relevant areas are asked throughout the study at specified intervals.
“In addition, they recommended systematic monitoring so that general and specific questions that target the relevant areas are asked throughout the study at specified intervals.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [26] Horigian VE, Robbins MS, Dominquez R, Ucha J, Rosa CL: Principles for defining adverse events in behavioural intervention research: lessons from a family-focused adolescent drug abuse trial. Clin Trials. 2010, 7: 58-68. source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationThe active treatment will increase the variance compared to no treatment control.
“as it is likely that the active treatment will increase the variance compared to no treatment control [7].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [7] Lilienfeld SC: Psychological treatments that cause harm. Perspect Psychol Sci. 2007, 2: 53-70. source
Not checked in the free run.
May combine two claims.
PremisecitationPsychotherapy patients are likely to hide negative material in particular, and even experienced therapists are rarely able to detect this.
“This is consistent with findings that psychotherapy patients are likely to hide negative material in particular, and that even experienced therapists are rarely able to detect this [27].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27] Hill CE, Thompson BJ, Cogar MC, Denman DW: Beneath the surface of long-term therapy: therapist and client report of their own and each other’s covert processes. J Couns Psychol. 1993, 40: 278-787. source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.
PremisecitationIdentification of a harmful effect is only the first step; what is then required is an understanding of the mechanism to explain such an effect.
“As Dimidjian and Hollon [8] point out, identification of a harmful effect is only the first step; what is then required is an understanding of the mechanism to explain such an effect”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [8] Dimidjian S, Hollon SD: How would we know if psychotherapy were harmful?. Am Psychol. 2010, 65: 21-33. source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationcitationSuch an understanding would lead to the avoidance of harmful interventions and contribute to identifying which psychological intervention works best for whom.
“Such an understanding would not only lead to the avoidance of harmful interventions, but also contribute to identifying which psychological intervention works best for whom.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningRecognition of an adverse effect of treatment at an individual level is important as it allows an identification of clinical deterioration in certain instances even when the intervention overall has been successful.
“This recognition of an adverse effect of treatment at an individual level is important as it allows an identification of clinical deterioration in certain instances even when the intervention overall has been successful.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
The NRES severe adverse events guidelines were developed for drug rather than psychological interventions.
“which were developed for drug rather than psychological interventions”
The paper relies on this without support.
The growing interest in the issue of harm from psychological interventions does not affect the recording of harm in clinical trials that assess psychological interventions.
“it nonetheless does not appear to affect the recording of harm (or lack thereof) in clinical trials that assess psychological interventions.”
The paper relies on this without support.
Indications of potential harm are adverse events, deterioration in mental state and the patient’s perceptions of having been adversely affected.
“Indications of potential harm are adverse events, deterioration in mental state and the patient’s perceptions of having been adversely affected.”
The paper relies on this without support.
Adverse events would be expected to be routinely recorded and reported in well-conducted randomized controlled trials.
“which one would expect to be routinely recorded and reported in well-conducted randomized controlled trials.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
All serious adverse events will be recorded and reported to an independent advisory board.
“All serious adverse events (SAEs) that are reported spontaneously by the participants or observed by the investigators during the trial will be recorded by the research team and will be reported to the independent advisory board [46].”
From A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: A randomized controlled trial (2020) · cites this paper as [46]
The Background section says specified adverse events and serious unexpected events must be recorded and reported by the Chief Investigator to the Research Ethics Committee, TSC, and DMC; the DMC provides independent review. It does not establish that all serious adverse events spontaneously reported by participants or observed by investigators in the citing authors’ trial will follow the stated procedure. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe criteria for reporting adverse events in the current study are based on the recommendations of Duggan, Parry, McMurran, Davidson, and Dennis (2014).
“The criteria for the reporting of adverse advents in the current study are based on the recommendations of Duggan, Parry, McMurran, Davidson, and Dennis (2014).”
From Acceptance and Commitment Therapy for perinatal mood and anxiety disorders: A feasibility and proof of concept study. (2020) · cites this paper as Duggan, Parry, McMurran, Davidson, and Dennis (2014)
Psychological interventions should be evaluated for negative effects.
“psychological interventions should be evaluated for negative effects [38]”
Some studies listed 'hospitalization' as a reason for (iCBT) dropout, which can be classified as a serious adverse event.
“However, some studies listed ‘hospitalization’ as a reason for (iCBT) dropout (Dear et al., 2017; Trompetter et al., 2015), which can be classified as a serious adverse event (Duggan et al., 2014).”
From Guided internet-based cognitive-behavioral therapy for patients with chronic pain: A meta-analytic review (2022) · cites this paper as Duggan et al., 2014
In general, the reporting of adverse events in RCTs of psychological interventions has been identified as weak.
“In general, the reporting of adverse events in RCTs of psychological interventions has been identified as weak. [105]”
From Efficacy of psychological therapies for irritable bowel syndrome: systematic review and network meta-analysis (2020) · cites this paper as [105]
Adverse events may not be spontaneously reported and will not come to light without systematic assessment methods.
“Finally, Duggan et al. (2014) noted that adverse events may not be spontaneously reported and will not come to light without systematic assessment methods.”
From Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples (2021) · cites this paper as Duggan et al. 2014
Adverse effects are sometimes narrowly defined, drawing on definitions from medical research, such that general deterioration in mental state or the appearance of new psychological symptoms might not be included.
“Second, adverse effects are sometimes narrowly defined, drawing on definitions from medical research, such that general deterioration in mental state or the appearance of new psychological symptoms might not be included (Duggan et al. 2014).”
From Frequency of Self-reported Unpleasant Events and Harm in a Mindfulness-Based Program in Two General Population Samples (2021) · cites this paper as Duggan et al. 2014
A previous review of 82 National Institute for Health Research funded clinical trials investigating psychological interventions found that adverse events are often assessed according to inappropriate criteria that are not therapy specific.
“A previous review of 82 National Institute for Health Research funded clinical trials investigating psychological interventions has found that adverse events are often assessed according to inappropriate criteria that are not therapy specific.125”
From Psychological interventions for chronic, non-specific low back pain: systematic review with network meta-analysis (2022) · cites this paper as [125]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Editorial-stage adverse-event percentage is incorrect
MinorTable 1 lists four of seven editorial-stage protocols as having adverse events. That is approximately 57%, not 50%.
Reported 50 · recomputed 57.142857
“| | Number with AEs | 4 (50%) | 0 | 1 (100%) | 0 | 3 (75%) |”
Incomplete trials: 47 in the text, 48 in Table 1
MinorThe Results count 47 trials still in progress, whereas Table 1 lists 48 incomplete studies in its protocols-only group.
“Of the remaining 54 trials, 47 were still in progress and another 7 were in the process of being published”
“| Incomplete studies (protocols only) | Number of protocols | 48 | 28 | 8 | 2 | 10 |”
Completed trials without protocols: 14 in the text, 13 in Table 1
MinorThe Results say that 14 completed trials lacked protocols, but Table 1 lists 13 completed studies without protocols.
“14 of these had protocols available but another 14 did not.”
“| Completed studies without protocols | Number of final reports | 13 | 7 | 2 | 1 | 3 |”
Discussion says 91 trials were examined rather than 82
MinorThe Methods say nine of the 91 studies were excluded, leaving 82 trials for examination; the Discussion instead says the examination covered 91 NIHR-funded trials.
“The failure to specify, record and report adverse events during psychological therapy was confirmed by our examination of 91 NIHR-funded trials.”
“Of these, nine were excluded, either because they were not trials (for example epidemiological surveys) or because there was insufficient information available for their inclusion. We divided these 82 trials into four groups:”
Drug and combined-intervention protocols total 11, not nine
MinorTable 1 lists eight drug-only and two combined protocols among incomplete studies, plus one drug-only protocol at the editorial stage. Thus the stated comparison includes 11 protocols if combined interventions are included, rather than nine.
Reported 9 · recomputed 11
“In contrast, drug interventions (together with drug and psychological interventions combined) mentioned adverse events in all of the 9 protocols examined.”
Incomplete-study adverse-event counts do not sum to the table total
MinorFor incomplete studies, Table 1 reports 31 protocols with adverse events, but its intervention-category counts sum to 32.
Reported 31 · recomputed 32
“| | Number with AEs | 31 | 17 (61%) | 8 (100%) | 2 (100%) | 5 (50%) |”
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- Authors
- Duggan, C., Parry, G., McMurran, M., Davidson, K., & Dennis, J.
- Affiliations
- University of Nottingham (GB)
- University of Sheffield (GB)
- University of Glasgow (GB)
- Campbell Collaboration (NO)
- Corresponding author
- Duggan, Conor
- Venue
- Trials
- Published
- 2014-08-27
- Volume
- 15
- Issue
- 1
- Pages
- 335-335
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4152561
- OpenAlex
- W2107036532
- Semantic Scholar
- ab2ed8afea3c1750fffbbad056250b484b901147
- Cited by
- 165
- References
- 34
- Citations by year
- 2026: 9 · 2025: 10 · 2024: 20 · 2023: 20 · 2022: 11 · 2021: 21 · 2020: 21 · 2019: 12 · 2018: 13 · 2017: 12 · 2016: 11 · 2015: 4 · 2014: 1
- FWCI
- 9.10
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Explore Bristol Research (submittedVersion)
- Funders
- National Institute for Health and Care Research (08/53/06, PB-PG-0408-15144)
- University of Southampton
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- adverse events, harms reporting, psychological intervention, clinical trials, National Institute for Health Research, personality disorders, trial steering committee
- MeSH terms
- Clinical Protocols, Clinical Trials as Topic, Humans, Psychotherapy, Biomedical Technology
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