Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02755103
Status:
COMPLETED
Last Update Posted:
2023-01-03
First Post:
2016-04-21
Brief Title:
Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study will modify an already existing therapy for individuals with substance use disorders to address Post Traumatic Stress Disorder PTSD in women enrolled in substance use disorders SUD treatment who suffer with both PTSD and SUD Mindfulness meditation has been shown to help individuals to cope with stress and regulate emotions Through meditation practice women will experience less distress related to PTSD symptoms and reduced substance use in response to emotional triggers Women enrolled in intensive SUD treatment at a community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based Relapse Prevention MBRP group sessions plus treatment as usual TAU or TAU alone The MBRP group sessions will replace 90 minutes of TAU group therapy Measures of feasibility of implementation acceptance and adherence will be obtained Preliminary efficacy for substance use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months follow-up
Detailed Description:
This randomized controlled pilot study will evaluate the feasibility and preliminary efficacy of MBRP plus usual community treatment as usual TAU compared to TAU alone TAU for women with substance use disordersSUD and PTSD enrolled in community substance abuse treatment Participants will be randomized to eight weekly 90-minute mixed individual and group-based MBRP in addition to TAU or TAU alone The eight sessions of MBRP will replace 8 sessions of seeking safety SS a trauma focused integrated therapy currently implemented in TAU Outcomes assessed will be
1 PTSD symptom severity as measured by the Clinicians Administered PTSD Scale CAPS and Post Traumatic Stress Disorder Symptom Scale-Self Report PSS-SR
2 Alcohol and substance use as measured by the Timeline Follow Back TLFB assessment and corroborated with urine drug screens
3 psychosocial functioning
4 Measure of emotional regulation and mindfulness awareness attention and acceptance
Recruitment of participants will primarily take place a community treatment program treating women with co-occurring PTSD and SUD
Following therapist training certification and piloting eligible women will be invited to participate in the study Interested potential participants will be screened for major inclusionexclusion criteria including age alcoholsubstance use history of trauma and psychiatrichealthmedication status If potentially eligible an Institutional Review Board IRB approved informed consent will be obtained and participants will be scheduled for a baseline assessment appointment If an individual is ineligible to participate in this research protocol she will continue in her usual community treatment program andor if indicated be referred for additional treatment services The investigators decided to limit the study group to women because they represent the largest percentage of patients with comorbid PTSD and SUDs and most have experienced sexual andor physical trauma So when trauma-focused treatment is delivered in a group setting for this population single sex groups create a safe comfortable and open atmosphere that is required for MM-based treatment and trauma focused work After having at least 7 days in standard treatment baseline assessments will be collected Women meeting inclusion with no exclusionary criteria will be randomized to MBRP plus TAU or TAU alone control Both groups will attend their standard intensive TAU program The eight MBRP therapy sessions will be integrated into the standard TAU program and replace 8 TAU SS sessions Participants will be introduced to the therapists and scheduled for their first individualsmall group session
The primary outcome measures for the efficacy portion of this study are 1 the effective reduction in PTSD symptom severity through the total score on the CAPS at the end of treatment between the two study groups and 2 the effective reduction in the proportion of days using and amount of use of alcoholsubstances during the final 30 days of treatment as measured by the TLFB verified by urine drug screens UDS In addition secondary endpoints will include CAPS scores at the 3 and 6 month post-intervention follow-up visits the 7 day point prevalence abstinence rates at each treatment post treatment and follow up visits Also PSS-SR Obsessive Compulsive Drinking and Substance Use Scale-Revised OCDS-R Addiction Severity Index-Lite ASI-Lite Difficulties in Emotional Regulation Scale DERS Mindfulness Acceptance and Awareness Questionnaire MAAS Five Facet Mindfulness Questionnaire FFQS and Cognitive and Affective Regulation Scale CAMS-R There will also be secondary endpoints and used to gain insight into potential effect modification and mediation Secondary analysis will also include the proportion of days using alcoholdrugs craving psychosocial functioning and emotional regulation Participants will be assessed weekly throughout the intervention at the end of the intervention and at 3- and 6- month follow-ups
1 PTSD symptom severity as measured by the Clinicians Administered PTSD Scale CAPS and Post Traumatic Stress Disorder Symptom Scale-Self Report PSS-SR
2 Alcohol and substance use as measured by the Timeline Follow Back TLFB assessment and corroborated with urine drug screens
3 psychosocial functioning
4 Measure of emotional regulation and mindfulness awareness attention and acceptance
Recruitment of participants will primarily take place a community treatment program treating women with co-occurring PTSD and SUD
Following therapist training certification and piloting eligible women will be invited to participate in the study Interested potential participants will be screened for major inclusionexclusion criteria including age alcoholsubstance use history of trauma and psychiatrichealthmedication status If potentially eligible an Institutional Review Board IRB approved informed consent will be obtained and participants will be scheduled for a baseline assessment appointment If an individual is ineligible to participate in this research protocol she will continue in her usual community treatment program andor if indicated be referred for additional treatment services The investigators decided to limit the study group to women because they represent the largest percentage of patients with comorbid PTSD and SUDs and most have experienced sexual andor physical trauma So when trauma-focused treatment is delivered in a group setting for this population single sex groups create a safe comfortable and open atmosphere that is required for MM-based treatment and trauma focused work After having at least 7 days in standard treatment baseline assessments will be collected Women meeting inclusion with no exclusionary criteria will be randomized to MBRP plus TAU or TAU alone control Both groups will attend their standard intensive TAU program The eight MBRP therapy sessions will be integrated into the standard TAU program and replace 8 TAU SS sessions Participants will be introduced to the therapists and scheduled for their first individualsmall group session
The primary outcome measures for the efficacy portion of this study are 1 the effective reduction in PTSD symptom severity through the total score on the CAPS at the end of treatment between the two study groups and 2 the effective reduction in the proportion of days using and amount of use of alcoholsubstances during the final 30 days of treatment as measured by the TLFB verified by urine drug screens UDS In addition secondary endpoints will include CAPS scores at the 3 and 6 month post-intervention follow-up visits the 7 day point prevalence abstinence rates at each treatment post treatment and follow up visits Also PSS-SR Obsessive Compulsive Drinking and Substance Use Scale-Revised OCDS-R Addiction Severity Index-Lite ASI-Lite Difficulties in Emotional Regulation Scale DERS Mindfulness Acceptance and Awareness Questionnaire MAAS Five Facet Mindfulness Questionnaire FFQS and Cognitive and Affective Regulation Scale CAMS-R There will also be secondary endpoints and used to gain insight into potential effect modification and mediation Secondary analysis will also include the proportion of days using alcoholdrugs craving psychosocial functioning and emotional regulation Participants will be assessed weekly throughout the intervention at the end of the intervention and at 3- and 6- month follow-ups
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA040968 | NIH | None | httpsreporternihgovquickSearchR01DA040968 |