Clinical trial NCT06646692: Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
Official title: Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Anxiety
Depression - Major Depressive Disorder
Keywords: homelessness
mindful self compassion
depression
substance use disorder
craving
PTSD
posttraumatic stress disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Does not meet other inclusion criteria

Primary outcomes:
measure: PTSD
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Drug Abuse Screening Test (DAST)
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Secondary outcomes:
measure: Beck Hopelessness Inventory
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Anxiety (PROMIS)
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Depression (PROMIS)
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Loneliness (PROMIS)
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Other outcomes:
measure: Self Compassion Scale
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Difficulties in Emotion Regulation Scale
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Mindful Attention Awareness Scale
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Moral Injury and Distress Scale
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Craving
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
measure: Trauma-related Shame Inventory
timeFrame: T1 (baseline, enrollment), T2 (immediate follow-up), T3 (4-months post-baseline)
Locations:
city: Pomona
country: United States
facility: Prototypes
state: California
Study officials:
References: