Evidence map›Paper›PMID 34114250›Full record

Trial reportJournal of traumatic stress2021

Sleep Quality Improvements After MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder.

Linnae Ponte, Lisa Jerome, Scott Hamilton, Michael C Mithoefer, Berra B Yazar-Klosinski, Eric Vermetten, Allison A Feduccia

Expression of concernErratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of traumatic stress, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It carries an expression of concern. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

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  18. Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2024
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 7 institutions in 2 countries.

Linnae PonteDepartment of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.
Lisa JeromeMAPS Public Benefit Corporation, San Jose, California, USA.
Scott HamiltonDepartment of Neurology and Neurological Sciences, Stanford School of Medicine, Stanford, California, USA.
Michael C MithoeferDepartment of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
Berra B Yazar-KlosinskiMAPS Public Benefit Corporation, San Jose, California, USA.
Eric VermettenDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.
Allison A FeducciaPsychedelic Support, Santa Cruz, California, USA.
Association to Benefit Children · USLeiden University Medical Center · NLMedical University of South Carolina · USMultidisciplinary Association for Psychedelic Studies · USPublic Service Electric and Gas (United States) · USStanford Medicine · USYale University · US

Funding

Multidisciplinary Association for Psychedelic Studies
6 · The paper itself

Abstract

Sleep disturbances (SDs) are among the most distressing and commonly reported symptoms in posttraumatic stress disorder (PTSD). Despite increased attention on sleep in clinical PTSD research, SDs remain difficult to treat. In Phase 2 trials, 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been shown to greatly improve PTSD symptoms. We hypothesized that MDMA-assisted psychotherapy would improve self-reported sleep quality (SQ) in individuals with PTSD and be associated with declining PTSD symptoms. Participants in four studies (n = 63) were randomized to receive 2-3 sessions of active MDMA (75-125 mg; n = 47) or placebo/control MDMA (0-40 mg, n = 16) during all-day psychotherapy sessions. The PSQI was used to assess change in SQ from baseline to the primary endpoint, 1-2 months after the blinded sessions. Additionally, PSQI scores were measured at treatment exit (TE) and 12-month follow-up. Symptoms of PTSD were measured using the CAPS-IV. At the primary endpoint, CAPS-IV total severity scores dropped more after active MDMA than after placebo/control (-34.0 vs. -12.4), p = .003. Participants in the active dose group showed more improvement in SQ compared to those in the control group (PSQI total score ΔM = -3.5 vs. 0.6), p = .003. Compared to baseline, SQ had improved at TE, p < .001, with further significant gains reported at 12-month follow-up (TE to 12-months ΔM = -1.0), p = .030. Data from these randomized controlled double-blind studies provide evidence for the beneficial effects of MDMA-assisted psychotherapy in treating SDs in individuals with PTSD.

Indexed as

N-Methyl-3,4-methylenedioxyamphetamineStress Disorders, Post-TraumaticCombined Modality TherapyHumansPsychotherapySleepSleep QualityTreatment OutcomeN-Methyl-3,4-methylenedioxyamphetamine

Identifiers

PMID34114250
PMCPMC8453707
OpenAlexW3171671394

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.