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Behavioural Intervention

Mindful Self-Compassion for PTSD (MSC for PTSD Trial)

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1 (baseline, enrollment), t2 (immediate follow-up), t3 (4-months post-baseline)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of a self-compassion intervention called Mindful Self Compassion (MSC) in treating PTSD and substance use disorder (SUD) in women experiencing homelessness. The

Who is the study for?

This trial is for unhoused women with PTSD and substance use disorders. Participants should be experiencing homelessness, have low socioeconomic status, and may also suffer from depression or anxiety. They must reside in a residential drug treatment site to participate.

What is being tested?

The study tests Mindful Self Compassion (MSC), adapted for trauma-exposed women with PTSD/SUD, against Treatment as Usual (TAU). It's an open-label cluster randomized trial where participants either attend a 6-week MSC program or receive regular check-ins without intervention.

What are the potential side effects?

Since the intervention involves mindfulness practices rather than medication, typical medical side effects are not expected. However, emotional discomfort or distress could arise when addressing traumatic experiences during sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1 (baseline, enrollment), t2 (immediate follow-up), t3 (4-months post-baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1 (baseline, enrollment), t2 (immediate follow-up), t3 (4-months post-baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (baseline, enrollment), t2 (immediate follow-up), t3 (4-months post-baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol Use Disorders Identification Test (AUDIT)

Drug Abuse Screening Test (DAST)

PTSD

Secondary study objectives

Anxiety (PROMIS)

Beck Hopelessness Inventory

Depression (PROMIS)

+1 more

Other study objectives

Craving

Difficulties in Emotion Regulation Scale

Mindful Attention Awareness Scale

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment as UsualExperimental Treatment1 Intervention

Selecting appropriate attention control groups for behavioral intervention research, particularly for mindfulness-based interventions, can be problematic. Comparator groups often also improve as they tend to target related mechanisms (e.g., social support, health behaviors, improved attention). After weighing the pros and cons, a "treatment as usual" (TAU) approach was selected, whereby the MSC will be compared to TAU. However, to control for the confound of weekly compensation, TAU participants will meet with study staff seven times over the 6-week period and fill out short psychosocial surveys on non-distressing topics (e.g., personality tests, attitudes surveys) in exchange for compensation commensurate with the MSC group. We believe this will also help with retention of the TAU group over time and strike an appropriate balance between controlling for the effects of study participation while minimizing confounds that often occur with active control groups in behavioral trials.

Group II: Mindful Self Compassion ClassesExperimental Treatment1 Intervention

(MSC) is a mind-body integrative health intervention that utilizes meditations, other contemplative practices, home practices, and experiential exercises (including group discussions) to increase SC. MSC can be done in groups of 10-25. To increase feasibility of MSC for use in residential drug treatment facilities we will aim to adapt MSC to 7 sessions (6 weekly sessions in alignment with the MSC short course plus the half day retreat included in the full course to facilitate skill consolidation). Sessions will be conducted in a group-based format: prior research found group-based formats equivalent to individual-level interventions for PTSD/SUD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treatment as Usual (TAU)

2016

Completed Phase 4

~3870

Mindful Self Compassion

2015

N/A

~200