Mindful Self-Compassion for PTSD
(MSC for PTSD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. It is best to discuss this with the research team or your healthcare provider.
What data supports the effectiveness of the treatment Mindful Self-Compassion for PTSD?
Is Mindful Self-Compassion safe for humans?
How is the Mindful Self-Compassion treatment different from other PTSD treatments?
Mindful Self-Compassion (MSC) is unique because it focuses on cultivating self-kindness, recognizing shared human experiences, and maintaining mindful awareness of suffering, which can help reduce PTSD symptoms. Unlike other treatments, MSC is an 8-week program that includes meditations and informal practices to integrate self-compassion into daily life, potentially offering a novel approach to managing PTSD.12456
What is the purpose of this trial?
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.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the MSC group complete a 6-week intervention consisting of six sessions and a half-day retreat
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, immediately post-intervention, and at a 4-month follow-up
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Mindful Self Compassion
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor