Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

Juul, Sophie; Gluud, Christian; Simonsen, Sebastian; Frandsen, Frederik Weischer; Kirsch, Irving; Jakobsen, Janus Christian

doi:10.1136/bmjebm-2020-111407

Cited by 64 publications

(60 citation statements)

References 109 publications

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“…A systematic review on methods of masking in randomized controlled trials with pharmacologic treatments concluded that reporting of condition masking is generally 'quite poor', and based on trials that have tested the success of masked methods, a high proportion of studies are effectively unmasked (Boutron et al 2006). This corroborates a recent systematic review of studies published in top psychiatry journals in 2017 and 2018, which found that only 59% of the trial reports included adequate reporting of masking outcomes (Juul et al 2020). Similarly, a comprehensive literature search found that masking was not maintained in 20/23 "double-blind" studies examining psychotropic drugs (Fisher and Greenberg 1993).…”

Section: Modern Era Clinical Research Design Elementssupporting

confidence: 84%

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Aday¹,

Heifets²,

Pratscher³

et al. 2021

Preprint

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Rationale: Psychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.Objective: In this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research.Results: We found that although some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants’ expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies concern study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy.Conclusion: Incorporating these design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increase the ability to discern treatment-specific effects of psychedelic therapy

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Section: Modern Era Clinical Research Design Elementssupporting

confidence: 84%

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Aday¹,

Heifets²,

Pratscher³

et al. 2021

Preprint

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show abstract

“…Fourth, even though the study is among the larger naturalistic studies focusing exclusively on AvPD, the number of included participants was still small, so there is an urgent need for replication in larger samples. Fifth, nearly all measures were based on self-reporting, which is subject to biases (Juul et al, 2021). Sixth, although we chose to report remission rates, these results should be interpreted with caution owing to the methodological problems associated with dichotomization of continuous scales (Altman and Royston, 2006).…”

Section: Discussionmentioning

confidence: 99%

Treating Avoidant Personality Disorder With Combined Individual Metacognitive Interpersonal Therapy and Group Mentalization-Based Treatment

et al. 2021

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Avoidant personality disorder (AvPD) is a severe but understudied condition. The current pilot project reports data on acceptability and outcomes of a novel treatment combining biweekly individual metacognitive interpersonal therapy (MIT) and weekly mentalization-based therapy (MBT) group therapy. A total of 30 patients with AvPD were consecutively included in the program. The primary outcome was AvPD-specific personality functioning measured by selfreport after treatment. Secondary outcomes were symptom distress, interpersonal problems, quality of life, and psychosocial functioning. Twenty-two patients completed treatment, with a mean duration of 13 months. On the primary outcome, effect sizes were generally moderate to large (effect size range: 0.59-1.10). On secondary outcomes, effect sizes were large (effect size range: 0.77-2.3). Both in terms of acceptability and outcomes, results are promising for the combination of MIT and MBT for AvPD. The approach is a strong candidate for further investigation in future large-scale randomized controlled trial.

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“…However, we will carefully consider the low sample size when interpreting the trial results. Fourth, as participants are not blinded to the allocated treatment, results from all participant-reported outcomes are at risk of bias [ 10 ]. Fifth, therapists are likewise not blinded to the allocated treatment and may have an allegiance to one of the interventions.…”

Section: Discussionmentioning

confidence: 99%

“…Outcome assessors, data managers, statisticians, the data safety and monitoring committee, and decision-makers will be blinded to treatment allocation [ 10 ]. Trial participants and therapists will not be blind to the treatment allocation.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)

Juul

Simonsen

Poulsen

et al. 2021

Trials

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Background Psychotherapy for borderline personality disorder is often extensive and resource-intensive. Mentalisation-based therapy is a psychodynamically oriented treatment option for borderline personality disorder, which includes a case formulation, psychoeducation, and group and individual therapy. The evidence on short-term compared with long-term mentalisation-based therapy is currently unknown. Methods/design The Short-Term MBT Project (MBT-RCT) is a single-centre, parallel-group, investigator-initiated, randomised clinical superiority trial in which short-term (20 weeks) will be compared with long-term (14 months) mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder. Outcome assessors, data managers, the data safety and monitoring committee, statisticians, and decision-makers will be blinded to treatment allocation. Participants will be assessed before randomisation and at 8, 16, and 24 months after randomisation. The primary outcome will be the severity of borderline symptomatology assessed with the Zanarini Rating Scale for Borderline Personality Disorder. Secondary outcomes will be functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey 36—mental component), global functioning (Global Assessment of Functioning), and proportion of participants with severe self-harm. In this paper, we present a detailed statistical analysis plan including a comprehensive explanation of the planned statistical analyses, methods to handle missing data, and assessments of the underlying statistical assumptions. Final statistical analyses will be conducted independently by two statisticians following the present plan. Discussion We have developed this statistical analysis plan before unblinding of the trial results in line with the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines, which should increase the validity of the MBT-RCT trial by mitigation of analysis bias. Trial registration ClinicalTrials.gov NCT03677037. Registered on 19 September 2018

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Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

Cited by 64 publications

References 109 publications

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Great Expectations: Recommendations for improving the methodological rigor of psychedelic clinical trials

Treating Avoidant Personality Disorder With Combined Individual Metacognitive Interpersonal Therapy and Group Mentalization-Based Treatment

Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)

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