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Rationale, design, and implementation of a clinical trial of a mindfulness-based relapse prevention protocol for the treatment of women with comorbid post traumatic stress disorder and substance use disorder.

Caroline Vrana, Therese K Killeen, Victoria Brant, Jana Mastrogiovanni, Nathaniel L Baker

Contemporary Clinical Trials October 1, 2017 DOI: 10.1016/j.cct.2017.07.024 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled pilot trial Pilot study Peer reviewed
Population Women with comorbid PTSD and SUD enrolled in a community-based SUD treatment program
Intervention Mindfulness-based Relapse Prevention (MBRP)
Topics PTSD Addiction Meditation
Keywords Behavioral therapy development Community research Mindfulness-based relapse prevention Sud
Key findings The paper presents the design and methods for a study modifying Mindfulness-based Relapse Prevention to address both PTSD and SUD in women, with plans to revise the manual, pilot the intervention, and conduct a randomized controlled pilot trial.

Abstract

Comorbid post-traumatic stress disorder (PTSD) and substance use disorders (SUD) commonly co-occur and is associated with a more complex clinical presentation with poorer clinical outcomes when compared with either disorder alone, and untreated PTSD can predict relapse to substance abuse. A number of integrated treatment approaches addressing symptoms of both PTSD and SUD concurrently demonstrate that both disorders can safely and effectively be treated concurrently. However, attrition and SUD relapse rates remain high and there is need to further develop new treatment approaches. Innovative approaches such as mindfulness meditation (MM) successfully used in the treatment of SUD may offer additional benefits for individuals with SUD complicated with PTSD. Specifically, Mindfulness-based Relapse Prevention (MBRP) integrates coping skills from cognitive-behavioral relapse prevention therapy with MM practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. Here we present the design and methods for the "Mindfulness Meditation for the Treatment of Women with comorbid PTSD and SUD" study, a Stage 1b behavioral development study that modifies MBRP treatment to address both PTSD and SUD in a community setting. This study is divided into three parts: revising the existing evidence-based manual, piloting the intervention, and testing the new manual in a randomized controlled pilot trial in women with comorbid PTSD and SUD enrolled in a community-based SUD treatment program.

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Other randomized controlled trials on PTSD, most cited first.

Study Year Design Participants
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Patients with severe PTSD, including those with comorbidities such as dissociation,... 2021 Randomized controlled trial n = 90
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Patients with chronic post-traumatic stress disorder refractory to both psychotherapy... 2010 Randomized controlled trial n = 20
Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures 2014 Randomized controlled trial n = 41
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. Military veterans and first responders aged 18 or older with chronic PTSD lasting 6... 2018 Randomized, double-blind, dose-response, phase 2 clinical trial n = 26
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD) Patients with treatment-resistant PTSD 2012 Randomized controlled trial n = 12

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