Cited by 40Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsPsychotherapy Techniques and Applications

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Control interventions in randomised trials among people with mental health disorders

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Faltinsen, Erlend, Todorovac, Adnan, Staxen Bruun, Laura, Hróbjartsson, Asbjørn, Gluud, Christian, Kongerslev, Mickey T, Simonsen, Erik, Storebø, Ole Jakob·2022·Cochrane Database of Systematic Reviews

DOI 10.1002/14651858.mr000050.pub2PMC PMC8979177

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Abstract

BACKGROUND: Control interventions in randomised trials provide a frame of reference for the experimental interventions and enable estimations of causality. In the case of randomised trials assessing patients with mental health disorders, many different control interventions are used, and the choice of control intervention may have considerable impact on the estimated effects of the treatments being evaluated. OBJECTIVES: To assess the benefits and harms of typical control interventions in randomised trials with patients with mental health disorders. The difference in effects between control interventions translates directly to the impact a control group has on the estimated effect of an experimental intervention. We aimed primarily to assess the difference in effects between (i) wait-list versus no-treatment, (ii) usual care versus wait-list or no-treatment, and (iii) placebo interventions (all placebo interventions combined or psychological, pharmacological, and physical placebos individually) versus wait-list or no-treatment. Wait-list patients are offered the experimental intervention by the researchers after the trial has been finalised if it offers more benefits than harms, while no-treatment participants are not offered the experimental intervention by the researchers. SEARCH METHODS: In March 2018, we searched MEDLINE, PsycInfo, Embase, CENTRAL, and seven other databases and six trials registers. SELECTION CRITERIA: We included randomised trials assessing patients with a mental health disorder that compared wait-list, usual care, or placebo interventions with wait-list or no-treatment . DATA COLLECTION AND ANALYSIS: Titles, abstracts, and full texts were reviewed for eligibility. Review authors independently extracted data and assessed risk of bias using Cochrane's risk of bias tool. GRADE was used to assess the quality of the evidence. We contacted researchers working in the field to ask for data from additional published and unpublished trials. A pre-planned decision hierarchy was used to select one benefit and one harm outcome from each trial. For the assessment of benefits, we summarised continuous data as standardised mean differences (SMDs) and dichotomous data as risk ratios (RRs). We used risk differences (RDs) for the assessment of adverse events. We used random-effects models for all statistical analyses. We used subgroup analysis to explore potential causes for heterogeneity (e.g. type of placebo) and sensitivity analyses to explore the robustness of the primary analyses (e.g. fixed-effect model). MAIN RESULTS: We included 96 randomised trials (4200 participants), ranging from 8 to 393 participants in each trial. 83 trials (3614 participants) provided usable data. The trials included 15 different mental health disorders, the most common being anxiety (25 trials), depression (16 trials), and sleep-wake disorders (11 trials). All 96 trials were assessed as high risk of bias partly because of the inability to blind participants and personnel in trials with two control interventions. The quality of evidence was rated low to very low, mostly due to risk of bias, imprecision in estimates, and heterogeneity. Only one trial compared wait-list versus no-treatment directly but the authors were not able to provide us with any usable data on the comparison. Five trials compared usual care versus wait-list or no-treatment and found a SMD -0.33 (95% CI -0.83 to 0.16, I² = 86%, 523 participants) on benefits. The difference between all placebo interventions combined versus wait-list or no-treatment was SMD -0.37 (95% CI -0.49 to -0.25, I² = 41%, 65 trials, 2446 participants) on benefits. There was evidence of some asymmetry in the funnel plot (Egger's test P value of 0.087). Almost all the trials were small. Subgroup analysis found a moderate effect in favour of psychological placebos SMD -0.49 (95% CI -0.64 to -0.30; I² = 53%, 39 trials, 1656 participants). The effect of pharmacological placebos versus wait-list or no-treatment on benefits was SMD -0.14 (95% CI -0.39 to 0.11, 9 trials, 279 participants) and the effect of physical placebos was SMD -0.21 (95% CI -0.35 to -0.08, I² = 0%, 17 trials, 896 participants). We found large variations in effect sizes in the psychological and pharmacological placebo comparisons. For specific mental health disorders, we found significant differences in favour of all placebos for sleep-wake disorders, major depressive disorder, and anxiety disorders, but the analyses were imprecise due to sparse data. We found no significant differences in harms for any of the comparisons but the analyses suffered from sparse data. When using a fixed-effect model in a sensitivity analysis on the comparison for usual care versus wait-list and no-treatment, the results were significant with an SMD of -0.46 (95 % CI -0.64 to -0.28). We reported an alternative risk of bias model where we excluded the blinding domains seeing how issues with blinding may be seen as part of the review investi

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Augmenting In Vivo Exposure With Fear Antagonistic Actions: A Preliminary Test⁎⁎We would like to thank David Seivers and Mind Alive, Inc., for supplying the D.A.V.I.D. devices used to conduct the APS treatment and to Melody Otto, Heather Zapalac, Andrea Cubriel, Brian Coquyt, and Mealika Brown for their assistance with data collection.Portions of these data were previously presented at the 2004 annual meeting of the Association for the Advancement of Behavior Therapy.This research was conducted in partial fulfillment of the Masters of Arts in Psychology for the first author (KBW) under the supervision of the senior author (MJT).
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Authors: Faltinsen, E., Todorovac, A., Staxen Bruun, L., Hróbjartsson, A., Gluud, C., Kongerslev, M. T., Simonsen, E., & Storebø, O. J.
Affiliations: University of Southern Denmark (DK)
Region Zealand (DK)
Psychiatric Research Unit; Region Zealand Psychiatry; Slagelse Denmark
University of Copenhagen (DK)
ORCID: Faltinsen, Erlend
Hróbjartsson, Asbjørn
Gluud, Christian
Kongerslev, Mickey T
Simonsen, Erik
Storebø, Ole Jakob
Venue: Cochrane Database of Systematic Reviews
Publisher: Wiley
Published: 2022-04-04
Volume: 2022
Issue: 4
Pages: MR000050-MR000050
ISSN: 1361-6137 (ISSN-L)
1465-1858
DOI: 10.1002/14651858.mr000050.pub2
PMC: PMC8979177
OpenAlex: W4224087072
Cited by: 40
References: 276
Citations by year: 2026: 9 · 2025: 8 · 2024: 7 · 2023: 5 · 2022: 9
FWCI: 1.06
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Cochrane Database of Systematic Reviews (publishedVersion)
PubMed Central (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, other-oa)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords: control measures, waitlist control, placebo interventions, mental illness, anxiety disorders, depression, schizophrenia, risk of bias, causal inference, benefit-harm balance, standardized mean difference, relative risk, risk difference
MeSH terms: Anxiety, Anxiety Disorders, Major Depressive Disorder, Humans, Mental Health, Psychotherapy, Randomized Controlled Trials as Topic

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