Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women

NCT ID: NCT06646692

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-05
• Study Completion Date: 2026-01-31

Brief Summary

Trauma exposure, posttraumatic stress disorder (PTSD), and substance use disorder (SUD) present major threats to public health. PTSD and SUD are major correlates of disability, often resulting in severe social and occupational impairment. Comorbidity between PTSD and SUD (PTSD/SUD) is common and frequently co-occurs with other mental health ailments including depression, anxiety, and suicidality. Comorbidity may be amplified in groups vulnerable to high trauma exposure, such as women with low socioeconomic status including women experiencing homelessness (WEH). Moreover, the reciprocal nature of PTSD/SUD (substances are used to cope with PTSD symptoms; substance use can create high-risk situations for new traumas to occur), can create a cycle of trauma and symptomatology leading to a critical health disparity.

PTSD/SUD can be costly and difficult to treat, with treatment completion often low and relapse rates often high. Low-cost, complementary interventions, such as self-compassion (SC) interventions, which target key mechanisms that maintain PTSD/SUD, could improve treatment outcomes. SC interventions include practices that build skills to improve emotional responses, cognitive understanding, and mindfulness. Recent research supports the benefit of SC interventions for reducing PTSD, SUD, and related comorbidities, potentially with large effects. However, sample sizes have generally been small and randomized designs infrequently used. Moreover, while SC interventions may act to improve key mechanisms of treatment response and/or symptom maintenance (e.g., emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving), such mediating factors have been underexplored. To address these limitations, the present proposal will implement community-based research principles and use a two phase, mixed-method design to adapt and test a widely used SC intervention (Mindful Self Compassion; MSC) for use with a sample of WEH with PTSD/SUD. The project will be conducted in partnership with a state-funded drug treatment facility that serves women and families experiencing high health disparities.

Phase I was completed in 2023 and adapted the standard MSC course for use with trauma-exposed WEH with PTSD/SUD using the ADAPT-ITT model, an eight-stage model that engages community partners to increase feasibility and acceptability of interventions for at-risk populations.

Phase II will be an open-label cluster randomized clinical trial (N=202) to test the benefit of the adapted MSC at improving primary (PTSD, substance use) and secondary outcomes (depression, anxiety, hopelessness) among a sample of WEH with PTSD/SUD residing in a residential drug treatment site. MSC (n=101) will be compared to Treatment as Usual (TAU; n=101). WEH in the MSC group will complete a 6-week (six sessions plus a half-day retreat) MSC intervention.

The TAU group will engage in weekly check-ins with the research team but will not receive an intervention. WEH will be assessed at baseline, immediately post-intervention, and at a 4-month follow-up. One-on-one interviews will be conducted with the MSC group to collect qualitative data on experiences. An exploratory aim will be to elucidate mechanism of treatment-response and maintenance or remission of PTSD symptoms. These potential mechanisms will include SC, emotion regulation/dysregulation, trauma-related guilt, trauma-related shame, moral injury, and craving.

Results may inform treatment for PTSD/SUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSD/SUD symptoms over time. Findings are relevant to military populations, which experience high rates of PTSD/SUD, and other populations disproportionately exposed to trauma.

Conditions

Posttraumatic Stress Disorder (PTSD); Anxiety; Depression - Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindful Self Compassion Classes

(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.

Group Type: EXPERIMENTAL

Mindful Self Compassion

Intervention Type: BEHAVIORAL

(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 as Usual

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 Type: EXPERIMENTAL

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

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.

Interventions

Mindful Self Compassion

(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.

Intervention Type: BEHAVIORAL

Treatment as Usual (TAU)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MSC; TAU

Eligibility Criteria

Inclusion Criteria

• Identifies as woman
• Age 18 and over
• Probable PTSD as judged by the PCL-5 (score of 31 or higher, indicated as having optimal signal detection)
• No cognitive impairment according to a score of < 10 on the Short-Blessed Test
• Experienced homelessness in the past 6 months or prior to incarceration ("spent night in public or private shelter or on the street")
• Able to speak and understand English.

Exclusion Criteria

• Not able to speak English
• Judged to be cognitively impaired, as indicated by score > 10 on the Short-Blessed Screener

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Dana Rose Garfin

Associate Professor-in-Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prototypes

Pomona, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dana Rose Garfin, PhD

Role: CONTACT

dgarfin@ucla.edu

4154079498

Facility Contacts

Mechelle Monroe, LMFT

Role: primary

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W911NF-23-1-0208:P00002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-000260

Identifier Type: -

Identifier Source: org_study_id