Mindful Self-Compassion for PTSD

(MSC for PTSD Trial)

Overseen By Mechelle Monroe, LMFT

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

202 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness program called Mindful Self-Compassion (MSC) to determine its effectiveness for women with PTSD (a condition where past trauma causes ongoing stress) and substance use disorder (struggling with alcohol or drug use). The goal is to assess whether MSC can improve symptoms such as depression, anxiety, and hopelessness. Participants will include women who have recently experienced homelessness and are living in a residential drug treatment facility. The study compares the effects of MSC classes to the usual treatment these women receive, focusing on improving emotional and mental health. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could enhance emotional well-being.

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 prior data suggests that the Mindful Self-Compassion intervention is safe for women experiencing homelessness with PTSD/SUD?

In earlier studies, treatments like Mindful Self-Compassion (MSC) have shown promise for people with posttraumatic stress disorder (PTSD) and substance use disorder (SUD). Research suggests that MSC can help lessen symptoms of PTSD and SUD and boost emotional well-being.

Most participants in past studies handled MSC well, with few reports of negative effects. This suggests that MSC is a safe option for many, including those dealing with trauma and addiction. However, while MSC has shown benefits in smaller studies, larger studies with more diverse groups are needed to fully understand its safety and effectiveness.

As a type of mindfulness practice, MSC rarely causes side effects. People might feel some emotional discomfort as they work through painful memories or feelings, but this usually doesn't last long. Overall, MSC is considered a low-risk treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindful Self-Compassion (MSC) for PTSD because it offers a unique approach compared to traditional treatments like cognitive behavioral therapy and medication. MSC focuses on building self-compassion through meditations, group discussions, and experiential exercises, which is different from most PTSD treatments that aim to directly confront trauma memories. This method not only supports emotional healing but also enhances social connections by being conducted in a group setting. By fostering self-kindness and mindfulness, MSC could provide a more holistic and accessible way to manage PTSD symptoms, especially for those in residential treatment settings.

What evidence suggests that Mindful Self-Compassion might be an effective treatment for PTSD/SUD?

Research has shown that Mindful Self-Compassion (MSC), which participants in this trial may receive, can help reduce symptoms of PTSD and substance use disorder (SUD). Participants in MSC reported fewer PTSD symptoms and less anxiety. In one study, 74% of participants completed the MSC program, and 96% gave it a positive review. This suggests that MSC is both effective and well-liked. The program teaches skills such as managing emotions and being mindful, which are important for addressing PTSD and SUD symptoms. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

I am a woman aged 18 or older.

Probable PTSD as judged by the PCL-5 (score of 31 or higher)

No cognitive impairment according to a score of < 10 on the Short-Blessed Test

Exclusion Criteria

Judged to be cognitively impaired, as indicated by score > 10 on the Short-Blessed Screener

Do not meet other inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the MSC group complete a 6-week intervention consisting of six sessions and a half-day retreat

6 weeks

6 sessions plus 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

4 months

Assessments at baseline, post-intervention, and 4-month follow-up

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Mindful Self Compassion

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment as Usual Experimental Treatment 1 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 Classes Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

An 8-week Compassionate Mind Training (CMT) course for 55 participants led to significant improvements in self-compassion, well-being, and positive emotions, while reducing self-criticism and distress, with effects maintained at a 3-month follow-up.

The study suggests that CMT can be a beneficial intervention for enhancing psychological health in community settings, highlighting the importance of self-compassion in improving overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compassionate Mind Training: An 8-week group for the general public. Irons, C., Heriot-Maitland, C.[2021]

The study involved seven participants with posttraumatic stress disorder and used semi-structured interviews to explore their experiences of developing self-compassion, revealing that self-criticism was a significant part of their identity and initially made self-compassion feel aversive and frightening.

Despite these challenges, participants found that through therapy and a supportive therapeutic relationship, they could overcome their fears and eventually experience positive emotions associated with self-compassion, suggesting that the journey from self-criticism to self-compassion is possible and can lead to improved psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of people's experiences of compassion-focused therapy for trauma, using interpretative phenomenological analysis. Lawrence, VA., Lee, D.[2014]

Self-compassion, which includes self-kindness, common humanity, and mindfulness, is linked to better mental health and less psychological distress, highlighting its importance in emotional well-being.

The Mindful Self-Compassion (MSC) program, an 8-week course with weekly sessions, effectively teaches participants to develop self-compassion through various meditative and practical exercises, demonstrating its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-compassion in clinical practice. Germer, CK., Neff, KD.[2013]

In a study of 115 U.S. combat veterans, higher levels of self-compassion were significantly associated with lower PTSD symptoms at baseline, indicating that self-compassion may play a crucial role in managing PTSD severity.

Self-compassion not only correlated with initial PTSD symptoms but also predicted PTSD symptom severity after 12 months, suggesting that interventions aimed at increasing self-compassion could be effective in treating chronic PTSD in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Compassion as a prospective predictor of PTSD symptom severity among trauma-exposed U.S. Iraq and Afghanistan war veterans. Hiraoka, R., Meyer, EC., Kimbrel, NA., et al.[2021]

A systematic review of 35 studies indicates that higher levels of self-compassion are consistently linked to lower symptoms of PTSD, suggesting that fostering self-compassion may be beneficial for individuals with trauma histories.

There is preliminary evidence that self-compassion-based interventions could help reduce PTSD symptoms, although the exact mechanisms behind these effects remain unclear and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-compassion, trauma, and posttraumatic stress disorder: A systematic review. Winders, SJ., Murphy, O., Looney, K., et al.[2021]

In a study of 115 U.S. Iraq/Afghanistan war veterans, both mindfulness and self-compassion were found to be negatively associated with PTSD symptom severity, indicating that higher levels of these traits may help reduce PTSD symptoms.

The research suggests that enhancing mindfulness and self-compassion could lead to decreased functional disability in veterans with PTSD, highlighting the potential for these traits to be targeted in therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness, Self-Compassion, Posttraumatic Stress Disorder Symptoms, and Functional Disability in U.S. Iraq and Afghanistan War Veterans. Dahm, KA., Meyer, EC., Neff, KD., et al.[2023]

A 12-week loving-kindness meditation program for veterans with PTSD showed significant improvements, with a large effect size in reducing PTSD symptoms (d = -0.89) and a medium effect size in reducing depression (d = -0.49) at the 3-month follow-up.

The study found that increased self-compassion played a key role in mediating the reductions in PTSD and depression symptoms, suggesting that loving-kindness meditation is a safe and effective intervention for enhancing mental health in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loving-kindness meditation for posttraumatic stress disorder: a pilot study. Kearney, DJ., Malte, CA., McManus, C., et al.[2022]

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