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Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD

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ClinicalTrials.gov Identifier: NCT02755103
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Therese K. Killeen, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Substance-Related Disorders Behavioral: Mindfulness Based Relapse Prevention (MBRP) Not Applicable

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 disorders(SUD) 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 Clinician's 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 inclusion/exclusion criteria including age, alcohol/substance use, history of trauma and psychiatric/health/medication 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 and/or 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 and/or 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 individual/small 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 alcohol/substances 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 alcohol/drugs, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: Women receiving MBRP plus TAU
Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group).
Behavioral: Mindfulness Based Relapse Prevention (MBRP)
MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses.

No Intervention: Women receiving TAU
Women will only receive treatment as usual (TAU less trauma focused group).



Primary Outcome Measures :
  1. Reduction in PTSD symptom severity. [ Time Frame: end of treatment at 8 weeks ]
    Effect size estimates of between group differences in PTSD symptom severity reduction as measured by the Clinician Administered PTSD Scale (CAPS)


Secondary Outcome Measures :
  1. Reduction in frequency of alcohol/substances [ Time Frame: final 30 days at study completion ]
    Reduction in the proportion of days using alcohol/substances during the final 30 days of treatment, as measured by the Time Line Follow Back (TLFB)

  2. Reduction in amount of alcohol/substances used [ Time Frame: final 30 days at study completion ]
    Reduction in amount of alcohol/substances used during the final 30 days of treatment, as measured by the Time Line Follow Back (TLFB)

  3. Reduction in frequency of alcohol/substances [ Time Frame: 3 and 6 months follow-up ]
    Reduction in the proportion of days using alcohol/substances for the past 30 days at 3- and 6- month follow -up as measured by the Time Line Follow Back (TLFB) .

  4. Reduction in quantity of alcohol/substances [ Time Frame: 3 and 6 months follow-up ]
    Reduction in the amount of use of alcohol/substances for the past 30 days at 3- and 6- month follow -up as measured by the Time Line Follow Back (TLFB) .

  5. Reduction in PTSD symptom severity. [ Time Frame: 3 and 6 month follow-up ]
    Group differences in PTSD symptom severity reduction as measured using the Clinician Administered PTSD Scale (CAPS).

  6. Between group increase in emotional regulation [ Time Frame: weekly, 3- and 6- months ]
    Measures of emotional regulation to gain insight into potential effect modification and mediation of the intervention. Emotional regulation as measured by the Difficulties in Emotional Regulation Scale (DERS).

  7. Between group increase in mindfulness [ Time Frame: weekly, 3- and 6- months ]
    Measures of mindfulness to gain insight into potential effect modification and mediation of the intervention. Mindfulness as measured by the Mindfulness Acceptance and Awareness Scale (MAAS).

  8. PTSD symptom Severity [ Time Frame: weekly for 8 weeks during intervention ]
    Reduction in PTSD symptom severity as measured by the PTSD Symptom Severity Scale - Self Report (PSS-SR) at the end of treatment .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 18 and 65 years of age enrolled in the Charleston Center (CC) intensive outpatient and New Life program treatment.
  • Able to comprehend English.
  • Meets fifth edition Diagnostic and Statistical Manual V (DSM V) criteria for current alcohol or substance use disorder and have used alcohol/substances in the 30 days prior to clinic treatment entry.
  • Meets DSM V criteria for current PTSD with a score greater than or equal to 25 on the CAPS 5.0.
  • Participants may also meet criteria for a mood or anxiety disorder. Participants on psychotropic medications for a mood or anxiety disorder must have been stabilized on medications for at least 4 weeks before therapy initiation.
  • Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  • Willing to commit to 8 therapy sessions, baseline, weekly and follow-up assessments.

Exclusion Criteria:

  • Current primary psychotic or thought disorder (i.e. Schizophrenia or schizoaffective disorder, mania), major depression with suicidal ideation, dissociative identity disorder and/or homicidal ideations.
  • Present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study.
  • In ongoing therapy for PTSD either within or outside of the CC, who are not willing to discontinue these therapies for the duration of the study therapy,
  • Unstable medical condition or one that may require hospitalization during the course of the study.
  • Women who are pregnant or planning to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755103


Contacts
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Contact: Hayley Feigl, MS 843-958-3474 feigl@musc.edu
Contact: Mary Shaw, BS 843-958-3406 shawm@musc.edu

Locations
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United States, South Carolina
The Charleston Center Recruiting
Charleston, South Carolina, United States, 29401
Contact: Chanda F Brown, PhD, LMSW    843-958-3472    CFBrown@charlestoncounty.org   
Contact: Rebecca Whitt       rwhitt@charlestoncounty.org   
Principal Investigator: Therese K Killeen, PhD, APRN         
Sub-Investigator: Chanda F Brown, PhD, LMSW         
Sub-Investigator: Bowen Sarah, PhD         
Sub-Investigator: Brady T Kathleen, MD PhD         
Sub-Investigator: Hamner Mark, MD         
Sub-Investigator: Baker Nate, MS         
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Therese K Killeen, PhD APRN Medical University of South Carolina

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Responsible Party: Therese K. Killeen, Research Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02755103     History of Changes
Other Study ID Numbers: Pro00048115
R01DA040968 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Therese K. Killeen, Medical University of South Carolina:
Mindfulness
Comorbid PTSD and SUD
Meditation

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders