Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03505749
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2018-04-07
Brief Title:
A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment
Sponsor:
Pacific University
Organization:
Pacific University
Study Overview
Official Title:
A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment A Randomized-controlled Pilot Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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:
More than 90 of women in substance use treatment report history of physical andor sexual trauma and up to 60 meet criteria for both substance use disorder SUD and Post Traumatic Stress Disorder PTSD PTSD typically precedes onset of SUD with substances used as a means to cope with physiological psychological and emotional symptoms resulting from the trauma Women with PTSD experience greater severity of addiction symptoms readmit into treatment more frequently than women without PTSD and tend to have poorer treatment outcomes Due to increased risk for exacerbation of PTSD on SUD severity and treatment success and the specific vulnerabilities and needs of women with this comorbidity SUD treatments that target both substance use and trauma recovery are needed However few interventions target both SUD and PTSD concurrently and fewer still are specific to women
Mindfulness-Based Relapse Prevention MBRP has been shown to decrease craving relapse rates and quantityfrequency of use across several substances and has shown acceptability in diverse populations MBRP integrates mindfulness practices with cognitive behavioral and exposure-based approaches to increase self-regulatory skills while experiencing triggers previously associated with substance use including challenging affective states such as those common to experienced trauma Adapting MBRP to incorporate trauma education and treatment approaches has the potential to effectively treat women with the dual vulnerabilities of trauma history and SUD
The current study is thus designed to determine feasibility acceptability and initial efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention TI-MBRP intervention for women in substance use treatment settings who have PTSD TI-MBRP integrates trauma education and treatment approaches drawn from Cognitive Processing Therapy CPT into the standard MBRP protocol to provide a trauma-informed approach to treating women in substance use treatment settings The current proposal will evaluate TI-MBRP using a randomized pre-post design with 100 women in residential substance abuse treatment Participants will be randomly assigned to participate in a 4-week TI-MBRP intervention or to continue with treatment as usual TAU Assessments will be collected pretest posttest and at one-month follow-up Data from this study will lay the groundwork for a larger scale clinical trial to determine the efficacy of TI-MBRP
Mindfulness-Based Relapse Prevention MBRP has been shown to decrease craving relapse rates and quantityfrequency of use across several substances and has shown acceptability in diverse populations MBRP integrates mindfulness practices with cognitive behavioral and exposure-based approaches to increase self-regulatory skills while experiencing triggers previously associated with substance use including challenging affective states such as those common to experienced trauma Adapting MBRP to incorporate trauma education and treatment approaches has the potential to effectively treat women with the dual vulnerabilities of trauma history and SUD
The current study is thus designed to determine feasibility acceptability and initial efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention TI-MBRP intervention for women in substance use treatment settings who have PTSD TI-MBRP integrates trauma education and treatment approaches drawn from Cognitive Processing Therapy CPT into the standard MBRP protocol to provide a trauma-informed approach to treating women in substance use treatment settings The current proposal will evaluate TI-MBRP using a randomized pre-post design with 100 women in residential substance abuse treatment Participants will be randomly assigned to participate in a 4-week TI-MBRP intervention or to continue with treatment as usual TAU Assessments will be collected pretest posttest and at one-month follow-up Data from this study will lay the groundwork for a larger scale clinical trial to determine the efficacy of TI-MBRP
Detailed Description:
Approximately 47 million women in the US experience sexual andor physical interpersonal violence IPV each year and 46 experience IPV in their lifetime More than 50 of interpersonal related violence occurs before age 25 In addition to acute chronic and fatal injuries caused by IPV women survivors of trauma WST are also at greater risk for organ and immune system diseases due to chronic stress reproductive dysfunctions and complications during pregnancy psychological disorders and the inability to access health care services and social support Estimated medical and mental health care costs for WST are 83 billion dollars per year as well as 8 million dollars lost in paid workdays Additionally annual health care cost of survivors can persist up to 15 years after the cessation of abuse
More than 90 of women admitted into substance use treatment settings have experienced IPV and 30-60 meet criteria for comorbid SUD and PTSD IPV typically precedes the onset of substance abuse as a means to cope with intense physiological psychological and emotional symptoms attributed to the event Research has demonstrated that for women PTSD symptoms may mediate the relationship between IPV and problematic SU Women with PTSD symptoms and SUD also experience greater severity of addiction symptoms compared to men and often readmit into treatment more frequently than men or women without traumatic histories Evidence also suggests that PTSD symptoms and SU yields poorer treatment outcomes than any other comorbid disorder or than SUD or PTSD alone Due to these high rates of comorbidity and interrelationship of symptoms particularly in women integrated treatments targeting both substance use and trauma recovery are needed However few such evidence-based interventions EBIs are available for WST in substance use treatment settings The few EBIs addressing SUD and trauma that are available have been mostly validated on males or specifically adapted for veteran populations Mindfulness-Based Relapse Prevention MBRP is one evidence-based intervention that has demonstrated efficacy in reducing substance craving relapse and negative affect in a variety of SUD populations It has also shown efficacy in incarcerated populations ethnic minority women and women offenders all of which have higher levels of trauma exposure compared to normative samples Research on Mindfulness-Based Interventions MBIs with trauma populations suggest that mindfulness skills can help decrease PTSD symptoms associated with avoidance and trauma-based cognitions and that MBIs are not iatrogenic for trauma populations A trauma informed adaptation of MBRP may thus offer an integrated intervention targeting both PTSD and SUD symptoms and addressing the etiologies and maintaining factors underlying the comorbidity
Given the particular needs and unique presentation of WST in substance use treatment settings effective evidence-based interventions must be developed to improve treatment outcomes The long-term goal of this line of research is to develop examine and disseminate an adapted evidence-based treatment for comorbid SUD and PTSD for women survivors of trauma WST The primary objective of this study is to develop and evaluate an intervention that integrates trauma education and treatment approaches used in Cognitive Processing Therapy CPT an evidence-based intervention for PTSD into the standard MBRP protocol to provide a trauma-informed approach to treating women in community-based substance use treatment settings The development phase of the study will use focus groups with staff and clients from a womens residential treatment center who have completed the MBRP course to inform the integration of trauma education using the CPT manual into the MBRP protocol Using a mixed-methods pre-post randomized-control design WST N100 enrolled in a residential treatment program will be randomized by cluster into an experimental TI-MBRP or control TAU group to determine feasibility acceptability preliminary efficacy and candidate mechanisms of TI-MBRP To accomplish the primary objective the following three aims are proposed
Aim 1 Development and refinement of a Trauma Informed-Mindfulness Based Relapse Prevention TI-MBRP protocol Informed by focus groups with staff and resident clients a protocol integrating evidence-based practices for SUDs and PTSD will be developed for women in substance use treatment endorsing PTSD symptoms
Aim 2 Determine feasibility and acceptability of TI-MBRP Based on prior studies of MBRP in similar populations we hypothesize TI-MBRP will be feasible and acceptable as measured by recruitment and retention rates weekly homework compliance client participation in groups and post-intervention client feedback
Aim 3 Determine meaningful changes at pre- post- 1- 3- 6- 9- and 12-month follow-up assessment time points in SUD and trauma-related outcomes and identify candidate mechanisms We hypothesize that as compared to TAU participation in TI-MBRP will result in
1 Significantly reduced trauma-related symptomology craving substance use reactivity to negative affect and experiential avoidance at post-intervention and maintenance of treatment outcomes at 12-month follow-up
2 Significant improvements in self-efficacy coping skills and mindfulness at post-intervention and maintenance of treatment outcomes at 12-month follow-up
Interested residents will be screened for eligibility based on the InclusionExclusion Screening Tool Breslaus Short Screening Scale and Suicidal Behaviors Questionnaire Eligible participants will be provided with a written informed consent The PI will review the informed consent with participants and answer any questions or concerns that participants may have about study procedures confidentiality data analysis and dissemination of results Once written informed consent is obtained participants will be notified of the group start date within one week of signing the consent form Participants will be asked to complete a battery of paper-and-pencil assessments within one week prior to the start of the first session Paper-and-pencil assessments will take no more than 60 minutes to complete
Experimental and Treatment-As-Usual TAU groups will be implemented simultaneously for maximization of participants within the given time frame totaling 10 groups over a 10-month period Participants will complete a battery of self-report assessments at baseline Then using computer randomizing software participants will be randomized by cluster into either an experimental or TAU group before the start of the first session After the first session all participants will be given an iPod touch with audio-recordings of guided meditation practices used in the intervention ie body scan breath awareness to use as a part of their daily homework requirements All iPod touch devices will include iMINDr a software application developed to track frequency and duration of home meditation practice Participants will then complete a post-course assessment battery within one week of the completion of the 4-week course If participants are unable to be physically present to complete the post-course assessment they will be offered a phone interview during which they will be administered self-report assessment measures orally
One week after post-course assessment participants will be invited to participate in an hour long audio-recorded focus group to discuss helpful aspects of the intervention as well as what could be changed Focus group audio recordings will be transcribed verbatim and analyzed in NVivo 11 by independent coders using a Constant Comparative Analysis
Participants will be asked to complete additional paper-and-pencil assessments at 1- 3- 6- 9- and 12-months following post course If participants are unable to physically attend follow-up assessment they will be offered a phone interview with self-report assessments administered orally
More than 90 of women admitted into substance use treatment settings have experienced IPV and 30-60 meet criteria for comorbid SUD and PTSD IPV typically precedes the onset of substance abuse as a means to cope with intense physiological psychological and emotional symptoms attributed to the event Research has demonstrated that for women PTSD symptoms may mediate the relationship between IPV and problematic SU Women with PTSD symptoms and SUD also experience greater severity of addiction symptoms compared to men and often readmit into treatment more frequently than men or women without traumatic histories Evidence also suggests that PTSD symptoms and SU yields poorer treatment outcomes than any other comorbid disorder or than SUD or PTSD alone Due to these high rates of comorbidity and interrelationship of symptoms particularly in women integrated treatments targeting both substance use and trauma recovery are needed However few such evidence-based interventions EBIs are available for WST in substance use treatment settings The few EBIs addressing SUD and trauma that are available have been mostly validated on males or specifically adapted for veteran populations Mindfulness-Based Relapse Prevention MBRP is one evidence-based intervention that has demonstrated efficacy in reducing substance craving relapse and negative affect in a variety of SUD populations It has also shown efficacy in incarcerated populations ethnic minority women and women offenders all of which have higher levels of trauma exposure compared to normative samples Research on Mindfulness-Based Interventions MBIs with trauma populations suggest that mindfulness skills can help decrease PTSD symptoms associated with avoidance and trauma-based cognitions and that MBIs are not iatrogenic for trauma populations A trauma informed adaptation of MBRP may thus offer an integrated intervention targeting both PTSD and SUD symptoms and addressing the etiologies and maintaining factors underlying the comorbidity
Given the particular needs and unique presentation of WST in substance use treatment settings effective evidence-based interventions must be developed to improve treatment outcomes The long-term goal of this line of research is to develop examine and disseminate an adapted evidence-based treatment for comorbid SUD and PTSD for women survivors of trauma WST The primary objective of this study is to develop and evaluate an intervention that integrates trauma education and treatment approaches used in Cognitive Processing Therapy CPT an evidence-based intervention for PTSD into the standard MBRP protocol to provide a trauma-informed approach to treating women in community-based substance use treatment settings The development phase of the study will use focus groups with staff and clients from a womens residential treatment center who have completed the MBRP course to inform the integration of trauma education using the CPT manual into the MBRP protocol Using a mixed-methods pre-post randomized-control design WST N100 enrolled in a residential treatment program will be randomized by cluster into an experimental TI-MBRP or control TAU group to determine feasibility acceptability preliminary efficacy and candidate mechanisms of TI-MBRP To accomplish the primary objective the following three aims are proposed
Aim 1 Development and refinement of a Trauma Informed-Mindfulness Based Relapse Prevention TI-MBRP protocol Informed by focus groups with staff and resident clients a protocol integrating evidence-based practices for SUDs and PTSD will be developed for women in substance use treatment endorsing PTSD symptoms
Aim 2 Determine feasibility and acceptability of TI-MBRP Based on prior studies of MBRP in similar populations we hypothesize TI-MBRP will be feasible and acceptable as measured by recruitment and retention rates weekly homework compliance client participation in groups and post-intervention client feedback
Aim 3 Determine meaningful changes at pre- post- 1- 3- 6- 9- and 12-month follow-up assessment time points in SUD and trauma-related outcomes and identify candidate mechanisms We hypothesize that as compared to TAU participation in TI-MBRP will result in
1 Significantly reduced trauma-related symptomology craving substance use reactivity to negative affect and experiential avoidance at post-intervention and maintenance of treatment outcomes at 12-month follow-up
2 Significant improvements in self-efficacy coping skills and mindfulness at post-intervention and maintenance of treatment outcomes at 12-month follow-up
Interested residents will be screened for eligibility based on the InclusionExclusion Screening Tool Breslaus Short Screening Scale and Suicidal Behaviors Questionnaire Eligible participants will be provided with a written informed consent The PI will review the informed consent with participants and answer any questions or concerns that participants may have about study procedures confidentiality data analysis and dissemination of results Once written informed consent is obtained participants will be notified of the group start date within one week of signing the consent form Participants will be asked to complete a battery of paper-and-pencil assessments within one week prior to the start of the first session Paper-and-pencil assessments will take no more than 60 minutes to complete
Experimental and Treatment-As-Usual TAU groups will be implemented simultaneously for maximization of participants within the given time frame totaling 10 groups over a 10-month period Participants will complete a battery of self-report assessments at baseline Then using computer randomizing software participants will be randomized by cluster into either an experimental or TAU group before the start of the first session After the first session all participants will be given an iPod touch with audio-recordings of guided meditation practices used in the intervention ie body scan breath awareness to use as a part of their daily homework requirements All iPod touch devices will include iMINDr a software application developed to track frequency and duration of home meditation practice Participants will then complete a post-course assessment battery within one week of the completion of the 4-week course If participants are unable to be physically present to complete the post-course assessment they will be offered a phone interview during which they will be administered self-report assessment measures orally
One week after post-course assessment participants will be invited to participate in an hour long audio-recorded focus group to discuss helpful aspects of the intervention as well as what could be changed Focus group audio recordings will be transcribed verbatim and analyzed in NVivo 11 by independent coders using a Constant Comparative Analysis
Participants will be asked to complete additional paper-and-pencil assessments at 1- 3- 6- 9- and 12-months following post course If participants are unable to physically attend follow-up assessment they will be offered a phone interview with self-report assessments administered orally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None