Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646692
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSC for PTSD
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 PTSDSUD 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 PTSDSUD 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
PTSDSUD 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 PTSDSUD 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 andor symptom maintenance eg emotion regulationdysregulation 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 PTSDSUD 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 PTSDSUD 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 N202 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 PTSDSUD residing in a residential drug treatment site MSC n101 will be compared to Treatment as Usual TAU n101 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 regulationdysregulation trauma-related guilt trauma-related shame moral injury and craving
Results may inform treatment for PTSDSUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSDSUD symptoms over time Findings are relevant to military populations which experience high rates of PTSDSUD and other populations disproportionately exposed to trauma
PTSDSUD 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 PTSDSUD 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 andor symptom maintenance eg emotion regulationdysregulation 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 PTSDSUD 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 PTSDSUD 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 N202 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 PTSDSUD residing in a residential drug treatment site MSC n101 will be compared to Treatment as Usual TAU n101 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 regulationdysregulation trauma-related guilt trauma-related shame moral injury and craving
Results may inform treatment for PTSDSUD in WEH and other groups experiencing high health disparities and provide valuable insights into mechanisms underlying PTSDSUD symptoms over time Findings are relevant to military populations which experience high rates of PTSDSUD and other populations disproportionately exposed to trauma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None