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

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.

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.