The chronic pain skills study: Protocol for a randomized controlled trial comparing hypnosis, mindfulness meditation and pain education in Veterans

May combine two claims.

Mindfulness meditation reduces pain intensity, pain interference, and pain-related affect.

“research demonstrating that MM can lead to reductions in pain intensity,[16] pain interference,[15, 29] and pain-related affect,[30, 31]”

• cites [16] sourcePartly supported

  The Results report a small decrease in pain with mindfulness meditation across 30 trials, but rate the evidence as low quality. The Results table includes measures of disability and pain unpleasantness, yet the paper does not establish reductions in pain interference and pain-related affect as separate outcomes. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [15] sourceSupported
• cites [29] sourceNot checked — no full text of the source
• cites [30] sourceNot checked — no full text of the source
• cites [31] sourceNot checked — no full text of the source

May combine two claims.

Preliminary evidence indicates hypnosis is an effective treatment for depression, insomnia, and PTSD.

“there is preliminary evidence suggesting that HYP is an efficacious way to treat depression,[22] insomnia[23, 24], and Posttraumatic Stress Disorder (PTSD),[23, 25, 26].”

• cites [22] sourceNot checked — no full text of the source
• cites [23] sourceNot checked — no full text of the source
• cites [24] sourcePartly supported

  The review’s Comparison of Positive, Mixed, and Negative Studies section reports positive sleep outcomes in 58.3% of included studies, supporting preliminary evidence for insomnia treatment. Its Description of the Subset of Studies Targeting Sleep reports improved PTSD symptoms in one trial, but another found that hypnosis did not augment PTSD recovery during trauma-focused treatment. The broader claim that hypnosis is efficacious for PTSD therefore exceeds the review’s mixed findings; depression is attached to a different citation in the citing sentence. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites [25] sourceNot checked — no full text of the source
• cites [26] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Research into biological mechanisms of hypnosis and mindfulness meditation has centered on brain oscillations.

“Research on biological mechanisms that may underlie HYP and MM has focused on brain oscillations.[37, 38]”

• cites [37] sourcePartly supported

  The Abstract (page not provided) says the review examines brain oscillations as a possible mechanism of hypnosis, and the “Brain oscillation patterns and hypnosis” section describes decades of research on that link. The paper mentions meditation, but these passages do not establish that research into the biological mechanisms of mindfulness meditation has likewise focused on brain oscillations. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [38] sourceNot checked — no full text of the source

May combine two claims.

Hypnosis and mindfulness meditation are promising for multiple chronic pain conditions and are considered priorities for additional research and dissemination.

“Two self-management approaches, hypnosis (HYP)[12–14] and mindfulness meditation(MM)[15–17], show promise across a range of chronic pain conditions and have been identified as priorities for further study and dissemination.[18]”

• cites [12] sourceNot checked — no full text of the source
• cites [13] sourceSupported
• cites [14] sourceNot checked — no full text of the source
• cites [15] sourceSupported
• cites [16] sourceSupported
• cites [17] sourcePartly supported

  The section “Mindfulness meditation improves chronic pain symptomology” reports benefits across several pain conditions and calls for further research on mindfulness for chronic low back pain. The paper mentions hypnosis only as a mechanism of pain relief; it does not identify both hypnosis and mindfulness as priorities for further study and dissemination. Page numbers are unavailable in our copy. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [18] sourcePartly supported

  The Psychological/Behavioral Therapies section identifies mindfulness-based stress reduction as a priority for implementation research and dissemination. It says hypnosis and meditation have sufficient evidence for clinical use but need further efficacy or effectiveness research before the focus shifts solely to implementation. Thus, the paper supports further study of those approaches, but not an unqualified dissemination priority for hypnosis. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

Mindfulness meditation is effective for sleep problems, anxiety, and depression, which often co-occur with pain in Veterans.

“MM has also been shown to be effective for treating conditions frequently co-occurring with pain in Veterans, including sleep problems[32, 33], anxiety,[31, 34] and depression.[35, 36]”

• cites [32] sourcePartly supported

  The Mean sleep scores and Conclusion sections (pages unavailable) report a small improvement in sleep quality immediately after MBSR among women treated for breast cancer. They report no significant effect at six or twelve months. This source supports the sleep-problems portion of the cited sentence, but not effectiveness in Veterans or a sustained treatment effect; the anxiety and depression claims have separate citations. (LLM, conf=0.87)

  Experimental — accuracy not yet measured
• cites [33] sourceNot checked — no full text of the source
• cites [31] sourceNot checked — no full text of the source
• cites [34] sourceNot checked — no full text of the source
• cites [35] sourceSupported
• cites [36] sourceSupported

May combine two claims.

Chronic pain is biopsychosocial, and accumulating evidence supports interventions that treat pain from this holistic perspective.

“Chronic pain is a biopsychosocial condition, and mounting evidence supports the efficacy of interventions that target pain from this more holistic perspective.[41, 90]”

• cites [41] sourceSupported
• cites [90] sourceNot checked — no full text of the source

May combine two claims.

Education is a well-known behavioral chronic pain treatment that has been shown to be engaging and helpful.

“Education is a familiar behavioral treatment for chronic pain that is shown to be interesting and beneficial,[47] but is not expected to have a neuromodulator effect, nor a direct effect on pain intensity.[46]”

• cites [47] sourcePartly supported

  The Background and Discussion describe patient education as a common component of multidisciplinary chronic-pain care and report benefits for pain management. The review does not establish that patients find education interesting or engaging, and its benefits are qualified as occurring within multidisciplinary interventions. The neuromodulator and direct-pain-intensity assertions are attached to a different citation and are not judged here. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim. May combine two claims.

Prospective participants are told each condition is a pain self-management intervention that prior patients found helpful, and that the study aims to learn which intervention helps which outcomes, to equalize outcome expectancies.

“prospective participants will be told that each of the three conditions is a type of “pain self-management” intervention that previous patients have found to be helpful, and that the purpose of the study is to determine which of these interventions is most helpful for which outcomes.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The trial is registered on ClinicalTrials.gov under identifier NCT02653664.

“The trial is registered on ClinicalTrials.gov, Identifier NCT02653664.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Intervention clinicians are not blinded to condition but are blinded to participants' study status and to the specific hypotheses.

“The clinicians who administer the study interventions will not be blind to condition but will be blind to the status of participants in their groups (who may or may not be enrolled in the research study) and to the specific study hypotheses.”

Classified as probably not a substantial claim.

Participants are blinded to the study hypotheses.

“Participants will be blind to the study hypotheses.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Each intervention facilitator leads all three 8-week interventions once per year in randomized counter-balanced order.

“Intervention facilitators will lead each of the three 8-week interventions once during a year, in randomized counter-balanced order.”

Classified as probably not a substantial claim.

The study interventions are equivalent in time and structure.

“The study interventions will be equivalent in terms of time and structure.”

Classified as probably not a substantial claim.

Medication use is assessed throughout the study so changes in pain medication can be controlled for.

“We will assess medication use throughout the course of the study to ensure we can control for changes in pain medication use.”

Classified as probably not a substantial claim.

Outcome assessment staff remain blinded to treatment condition during follow-up.

“All research staff conducting the outcome assessments will remain blind to treatment condition throughout the follow-up period.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The University of Washington, VAPSHCS, and the sponsor approved all study methods and procedures.

“All study methods and procedures have been approved by the Human Participants Review boards at the University of Washington and the Veterans Affairs Puget Sound Health Care System (VAPSHCS), and the study sponsor.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A VA-based clinical psychologist investigator screens all prospective participants psychologically by reviewing medical records with a standard CRF.

“A study investigator who is a VA-based Clinical Psychologist (RW) will conduct psychological screens of all prospective participants by reviewing medical records using a standard case report form (CRF).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Reasons for ineligibility are collected to adhere to CONSORT standards.

“reasons for ineligibility will be collected for purposes of adhering to the Consolidated Standards of Reporting Trials (CONSORT) standards.[49]”

• cites [49] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Every study participant will give informed consent.

“All study participants will provide informed consent.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The reviewing psychologist evaluates psychologically relevant inclusion and exclusion criteria to confirm no suicide risk, behavioral concerns, or psychotic disorders/symptoms.

“The reviewing psychologist will evaluate the psychologically-relevant inclusion and exclusion criteria to ensure absence of suicide risk, behavioral concerns, and psychotic disorders or symptoms.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

When self-report and chart review are insufficient, the psychologist phones prospective participants, conducts a brief standardized interview on risk factors, and uses clinical judgment to decide eligibility and safety.

“In instances where this information cannot be determined by prospective participant self-report and chart review alone, the psychologist will contact prospective participants by telephone and conduct a brief standardized interview to assess these potential risk factors and use clinical discretion as indicated to determine eligibility and safety.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Group assignment uses a Microsoft Excel spreadsheet with random numbers generated by the research manager with biostatistician guidance.

“Assignment to one of the three groups will be accomplished with a Microsoft Excel® spreadsheet with random numbers created by the research manager with the guidance of the biostatistician.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Projected enrollment is 343 to ensure complete data from 240 participants and enough capacity to enroll equivalent cohorts.

“Projected enrollment will be n=343, to ensure complete data from n=240 participants and to ensure adequate capacity to enroll equivalent cohorts throughout the study (25–30 participants will be enrolled in each of the study’s anticipated 12 cohorts).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Facilitators are paired to co-lead groups, and at least one co-facilitator per group must attend supervision calls.

“Intervention facilitators will be assigned in pairs to co-lead the study groups and at least one co-facilitator from each group will be required to attend the supervision calls.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Intervention facilitators are trained and supervised by study investigators who each have recognized expertise in at least one study intervention.

“Intervention facilitators will be trained and supervised by the study investigators, each of whom has recognized expertise in at least one of the study interventions.”

Classified as probably not a substantial claim. May combine two claims.

A separate database with no treatment assignment information is used for tracking and entering assessments, keeping outcome assessors blinded and synchronizing assessment schedules with intervention progress.

“A separate database without any information about treatment assignment will be used to track and enter assessments. This will be done to ensure that research staff members who will perform outcome assessments remain blind to group assignment and that assessment schedules are synchronized with intervention progress.”

May combine two claims.

Recruitment and assessment staff are blinded to the randomization database, preserving allocation concealment.

“All research staff conducting recruitment and assessments will be blind to the randomization assignment database, maintaining concealment of allocation.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Inclusion criteria are designed to maximize ecological validity.

“Inclusion criteria were designed to maximize ecological validity”

Classified as probably not a substantial claim. May combine two claims.

The person randomizing participants is blinded to identifying information and to the treatment assignment code.

“The staff member who will randomize participants will be blind to all identifying information and will also be blind to the code identifying specific treatment assignments.”

Classified as probably not a substantial claim.

Groups are offered in synchronized cohorts so availability, convenience, timing, and access are equivalent at randomization.

“Groups will be offered in synchronized cohorts (each of the three treatment conditions will start within the same week) to ensure equivalent availability, convenience, timing, and access at the point of randomization.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Intervention facilitators take part in bi-weekly telephone supervision and consultation calls specific to the intervention they currently lead.

“Intervention facilitators will participate in bi-weekly telephone-based supervision and consultation calls specific to the current intervention they are leading.”

Classified as probably not a substantial claim.

The investigator handling psychological screening, group scheduling, and adverse events does not take part in allocation/randomization or assessments.

“The investigator responsible for psychological screening, clinical scheduling of group appointments (RW), and management of adverse events will not participate in allocation/randomization or assessments.”

May combine two claims.

Hypnosis has been shown to increase perceived control over pain and overall well-being.

“HYP has also been shown to increase a sense of control over pain and overall well-being.[27, 28]”

• cites [27] sourceNot checked — no full text of the source
• cites [28] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Study investigators are not blinded to allocation but have minimal direct contact with subjects.

“Study investigators will not be blind to allocation but will also have minimal direct interaction with subjects.”

Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

Including non-research participants ethically prevents participants from experiencing coercion.

“(4) ethically ensuring participants do not experience coercion.”

Classified as probably not a substantial claim.

All analyses use an intention-to-treat approach, analyzing every randomized participant regardless of treatment received.

“An intention-to-treat approach will be used for all analyses; data from all participants who were randomized to their respective assigned treatment, regardless of how much they actually receive of that treatment, will be analyzed.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The fidelity rating system evaluates delivery of intervention-specific and shared components and of prohibited elements.

“The fidelity rating system will assess delivery of components unique and not unique (group rules, introductions, homework assigned) to each intervention and proscribed intervention elements (e.g., use of MM in an EDU session).”

Probably not a substantial claim: may not pass S3 (load-bearing).

All measures are administered in their validated forms unless the paper notes otherwise.

“In all instances, measures will be administered in their validated forms unless otherwise noted.”

Classified as probably not a substantial claim.

All assessments are given by research staff who do not know participants' group assignments.

“All assessments will be administered by research staff members who are blind to group assignment.”

May combine two claims.

Including non-research participants increases class enrollment, helps reach critical mass, and supports facilitator workload credit.

“(2) increased enrollment in the intervention classes, thus assisting with achieving “critical mass” and bolstering workload credit for the group facilitators;”

Classified as probably not a substantial claim.

Brain activity is assessed with standard procedures intended to ensure valid and reliable EEG measurement.

“Brain activity (Aim 2) will be assessed using standard practices for ensuring valid and reliable EEG measures (e.g., careful training and supervision of research assistants in EEG assessment procedures, checking impedance of all sites, not assessing women during menses, instructing participants to avoid muscle activity during the assessment).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Every intervention session is audio-recorded, and a random quarter of them undergo formal review with a standardized fidelity checklist.

“All study intervention sessions will be audio recorded, and 25% of these will be randomly selected for formal review using a standardized fidelity checklist.”

May combine two claims.

This study is more methodologically rigorous than several earlier studies because it includes an active education control matched for time and attention, a broader chronic pain sample, and a larger sample.

“This study represents an increase in methodological rigor over several prior studies, by including an active control condition (EDU) matched for time and attention, a more generalized sample (i.e., adults with chronic pain of various types, durations, and etiologies), and a larger sample.”

May combine two claims.

The education materials comprise eight group sessions that participants in earlier trials found compelling, informative, and credible.

“The EDU materials will include 8 informational group sessions that participants in prior trials have indicated are compelling, informative, and credible.[59, 63]”

• cites [59] sourceNot checked — no full text of the source
• cites [63] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

If more than 5% of outcome data are missing or missingness is non-random, imputation methods modeling the joint outcome-missingness distribution will be used.

“If greater than 5% of data are missing and/or if it is determined that there are non-random missing outcomes data, specific imputation methods will be used to account for this by modeling the joint distribution of the outcome and the missing mechanism.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Before analysis, randomization effectiveness is checked by comparing baseline characteristics and potential confounders across the three arms.

“As a preliminary step, we will check the randomization effectiveness by comparing the observed baseline characteristic and potential confounders between the three study arms, using Fisher’s Exact or Wilcoxon-Mann-Whitney tests as indicated.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A second research staff member performs double data entry of source data.

“A second research staff member will complete double-entry of source data.”

May combine two claims.

Including non-research participants in intervention appointments is required to use clinical infrastructure and yields specific benefits.

“Including non-research participants in the study intervention appointments is a necessary precursor for utilizing clinical infrastructure and will offer several specific benefits:”

May combine two claims.

In a review of pain trials, a 2-point numerical rating scale difference corresponds to roughly a 30% change in most studies and to patient reports of much improvement.

“Additionally, in a review of pain trials, a 2-point difference on the NRS translates to approximately a 30% change in most studies, depending on average baseline levels of pain intensity, and to patient perceptions of “much improvement” on global impression of change measures.[87]”

• cites [87] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

A consensus panel recommended the numerical rating scale as a core pain intensity outcome for pain clinical trials to allow cross-trial comparison.

“A consensus panel has also recommended the NRS as a core outcome measure of pain intensity in clinical trials of pain treatments to facilitate comparison across multiple trials.[67]”

• cites [67]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Education is not expected to alter neuromodulatory processes or directly reduce pain intensity.

“Education is a familiar behavioral treatment for chronic pain that is shown to be interesting and beneficial,[47] but is not expected to have a neuromodulator effect, nor a direct effect on pain intensity.[46]”

• cites [46] sourceNot checked — no full text of the source

May combine two claims.

The study is better classified as an effectiveness trial than an efficacy trial because it is integrated into real-world clinical infrastructure, uses licensed/credentialed providers with varied expertise, and includes non-research participants in intervention classes.

“Though the proposed study has features of an efficacy trial (e.g., standardized administration of intervention), it is more accurately conceptualized as an effectiveness trial, based on its integration within real-world clinical infrastructure, utilization of licensed/credentialed existing providers who have varying levels of expertise in conducting these interventions, and inclusion of non-resear”

May combine two claims.

Including non-research participants provides high ecological validity and better access and logistics.

“(1) high ecological validity and improved access and logistics;”