MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial

Nature Medicine, Journal Year: 2023, Volume and Issue: 29(10), P. 2473 - 2480

Published: Sept. 14, 2023

This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical in participants moderate to severe post-traumatic stress disorder (PTSD). Changes Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) Sheehan Disability (SDS) functional impairment (key secondary were assessed by blinded independent assessors. Participants randomized MDMA-AT (n = 53) or 51). Overall, 26.9% (28/104) had PTSD, 73.1% (76/104) PTSD. ethnoracially diverse: 28 104 (26.9%) identified as Hispanic/Latino, 35 (33.7%) other than White. Least squares (LS) mean change CAPS-5 (95% confidence interval (CI)) was -23.7 (-26.94, -20.44) -14.8 (-18.28, -11.28) (P < 0.001, d 0.7). LS SDS CI) -3.3 (-4.03, -2.60) -2.1 (-2.89, -1.33) 0.03, 0.4). Seven a treatment emergent adverse event (TEAE) (MDMA-AT, n 5 (9.4%); therapy, 2 (3.9%)). There no deaths serious TEAEs. These data suggest that reduced symptoms diverse population generally well tolerated. ClinicalTrials.gov identifier: NCT04077437 .

Language: Английский

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Treatment of Posttraumatic Stress Disorder: A State-of-the-art Review

Current Neuropharmacology, Journal Year: 2023, Volume and Issue: 22(4), P. 557 - 635

Published: May 3, 2023

Abstract: This narrative state-of-the-art review paper describes the progress in understanding and treatment of Posttraumatic Stress Disorder (PTSD). Over last four decades, scientific landscape has matured, with many interdisciplinary contributions to its diagnosis, etiology, epidemiology. Advances genetics, neurobiology, stress pathophysiology, brain imaging have made it apparent that chronic PTSD is a systemic disorder high allostatic load. The current state includes wide variety pharmacological psychotherapeutic approaches, which are evidence-based. However, myriad challenges inherent disorder, such as individual barriers good outcome, comorbidity, emotional dysregulation, suicidality, dissociation, substance use, trauma-related guilt shame, often render response suboptimal. These discussed drivers for emerging novel including early interventions Golden Hours, interventions, medication augmentation use psychedelics, well targeting nervous system. All this aims improve symptom relief clinical outcomes. Finally, phase orientation recognized tool strategize position step progression pathophysiology. Revisions guidelines systems care will be needed incorporate innovative treatments evidence emerges they become mainstream. generation well-positioned address devastating disabling impact traumatic events through holistic, cutting-edge efforts research.

Language: Английский

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The efficacy of psychological interventions for adult post-traumatic stress disorder following exposure to single versus multiple traumatic events: a meta-analysis of randomised controlled trials

The Lancet Psychiatry, Journal Year: 2024, Volume and Issue: 11(2), P. 112 - 122

Published: Jan. 11, 2024

Language: Английский

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Psychological Associations of Multiple Disasters: A Longitudinal Study of Adolescents in Puerto Rico

Disaster Medicine and Public Health Preparedness, Journal Year: 2025, Volume and Issue: 19

Published: Jan. 1, 2025

Abstract Objectives Psychological reactions in response to disasters have been associated with increased mental health (MH) symptomatology, decreased quality of life (QOL), and post-traumatic stress (PTSD). This study provides a rare opportunity examine post disaster MH longitudinally sample adolescents. Methods From 2018-20, adolescents (12-18 years, N =228) were interviewed about exposure, QOL using the Adolescent Quality Life-Mental Health Scale (AQOL-MHS), psychological symptoms, diagnoses. Results Having an diagnosis PTSD are clear indicators worse Emotional Regulation (ER) ( P ≤ 0.03, 0.0001) Self-Concept (SC) 0.006, 0.002) QOL. Girls disproportionately affected all models for SC Social Context domains 0.0001, 0.01). Interaction results ER 0.05) 0.01) indicate that those improving over time at greater rate than without PTSD. Conclusions Recovery takes sex disparity girls was observed. different AQOL-MHS highlight how challenges experienced by multifaceted. Knowing who is risk can allow better resource allocation targeted population-based prevention strategies promote maintain resolve factors illnesses.

Language: Английский

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A randomized controlled trial of Deep Brain Reorienting: a neuroscientifically guided treatment for post-traumatic stress disorder

European journal of psychotraumatology, Journal Year: 2023, Volume and Issue: 14(2)

Published: Aug. 15, 2023

Background: Advanced neuroscientific insights surrounding post-traumatic stress disorder (PTSD) and its associated symptomatology should beget psychotherapeutic treatments that integrate these into practice. Deep Brain Reorienting (DBR) is a neuroscientifically-guided intervention targets the brainstem-level neurophysiological sequence transpired during traumatic event. Given contemporary have non-response rates of up to 50% high drop-out >18%, DBR investigated as putative candidate for effective treatment some individuals with PTSD.Objective: To conduct an interim evaluation effectiveness eight-session clinical trial videoconference-based versus waitlist (WL) control PTSD.Method: Fifty-four PTSD were randomly assigned (N = 29) or WL 25). At baseline, post-treatment, three-month follow-up, participants' symptom severity was assessed using Clinician Administered Scale (CAPS-5). This analysis registered U. S. National Institute Health (NCT04317820).Results: Significant between-group differences in CAPS-total all subscale scores (re-experiencing, avoidance, negative alterations cognitions/mood, arousal/reactivity) found at post-treatment (CAPS-total: Cohen's d 1.17) 3-month-follow-up (3MFU) 1.18). decreases observed within group pre – (36.6% reduction) pre-treatment 3MFU (48.6% reduction), whereas no significant occurred group. After DBR, 48.3% 52.0% longer met criteria. Attrition minimal one participant not completing treatment; eight participants lost 3MFU.Conclusions: These findings provide emerging evidence well-tolerated based on theoretical advances highlighting subcortical mechanisms symptomatology. Additional research utilizing larger sample sizes, neuroimaging data, comparisons adjacencies other approaches warranted.Trial registration: ClinicalTrials.gov identifier: NCT04317820..

Language: Английский

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Grasping Post-Traumatic Stress Disorder (PTSD) from the Perspective of Psychoneuroimmunoendocrinology (PNIE): Etiopathogenic Mechanisms and Relevance for the Integrative Management

Biological Psychiatry, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 1, 2025

Language: Английский

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Written Exposure Therapy Integrated with Cognitive Behavioral Skills for Alcohol Misuse: A Proof-of-Concept Study with Recent Sexual Assault Survivors

Cognitive and Behavioral Practice, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 1, 2025

Language: Английский

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A pilot study of twice-weekly group-based written exposure therapy for veterans in residential substance use treatment: effects on PTSD and depressive symptoms

Addiction Science & Clinical Practice, Journal Year: 2025, Volume and Issue: 20(1)

Published: Feb. 10, 2025

Abstract Background Posttraumatic stress disorder (PTSD) is highly comorbid with substance use disorders (SUDs), resulting in high prevalence of PTSD among individuals residential SUD care. However, there limited research on integrating trauma treatment into care settings. The aim the present project was to conduct an initial evaluation effects group-based Written Exposure Therapy (WET) and depressive symptoms that integrated programming for treatment. Methods Participants were 48 Veterans PTSD-SUD from a 28 day program at Affairs Medical Center. Eligible participants enrolled 5 sessions WET, delivered twice-weekly adapted group format. assessed each session Stress Disorder Checklist, DSM-5 version (PCL-5) Patient Health Questionnaire (PHQ-9). Results Over months, 76.2% target population successfully enrolled. Of sample, participants, 92% ( n = 44) completed 3 sessions, while 56% 28) sessions. Generalized Estimating Equations (GEE) showed significant within-person reductions over time, average decrease 3.18 per (χ² 23.21, p .006) moderate effect sizes d 0.46 0.51 mid- post-treatment). In addition, within-persons per-session reduction 1.13 23.10, .006). Conclusion Findings demonstrate brief, group-delivered WET feasible shows promise addressing could inform further efficacy testing implementation

Language: Английский

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A Randomized Clinical Trial of Prolonged Exposure Therapy With and Without Topiramate for Comorbid PTSD and Alcohol Use Disorder

American Journal of Psychiatry, Journal Year: 2025, Volume and Issue: unknown

Published: March 19, 2025

Posttraumatic stress disorder (PTSD) and alcohol use (AUD) frequently co-occur. Prolonged exposure (PE) is an effective treatment for PTSD but shows smaller effects in patients with co-occurring AUD. Topiramate may help reduce symptoms. This double-blind, placebo-controlled outpatient clinical trial compared 12 sessions of PE plus either topiramate or placebo. One hundred U.S. veterans (mean age=45 years [SD=12], 84% men) PTSD+AUD were randomly assigned to 16 weeks PE+topiramate (up 250 mg) PE+placebo examine on severity at posttreatment assessment 3- 6-month follow-ups. Percent heavy drinking days decreased significantly both conditions did not differ between groups. scores lower the group than assessment, The same patterns observed loss diagnosis meaningful symptom change. Change secondary outcomes (depression, quality life) conditions. was associated a greater reduction symptoms during active treatment. addition led more rapid pronounced reduction, which be benefit patients. Because maintained longer-term follow-up, extending time additional strategies prolong such useful. show added percent outcomes.

Language: Английский

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A Harm Reduction Framework for Integrated Treatment of Co-Occurring Opioid Use Disorder and Trauma-Related Disorders

Journal of Dual Diagnosis, Journal Year: 2024, Volume and Issue: 20(1), P. 52 - 85

Published: Jan. 2, 2024

The opioid epidemic has exposed a gulf in mental health research, treatment, and policy: Most patients with comorbid trauma-related disorder (TRD) use (OUD) (TRD + OUD) remain undiagnosed or unsuccessfully treated for the combination of TRD symptoms use. treatments tend to be psychotherapies that are not accessible practical many individuals OUD, due treatment models systematically incorporating principles harm reduction (HR). HR practices prioritize flexibility unequivocally improve outcomes save lives OUD. Considering urgent need OUD outcomes, we propose fields can meaningfully reconciled by integrating classic phasic TRD. Adding "prestabilization" phase – largely analogous precontemplation Stage Change creates opportunities advance clinical practice, policies potentially patient outcomes.

Language: Английский

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