A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment: A Randomized-controlled Pilot Trial
Phase: NA
Conditions: Substance Use Disorders, Post Traumatic Stress Disorder
Sponsor: Pacific University

COVER PAGE 
 
Title: A trauma-Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in 
Substance Use Treatment 
 
NCT03505749 
 
Document Date: 02/29/2020 
 

PROCEDURES AND STATISTICAL ANALYTIC PLAN 
This goal of this study was to develop and implement an integrated intervention protocol for a 
feasibility and initial efficacy trial of TI-MBRP. During the treatment development phase, 
information was gathered from focus groups with counselors and patients. The trial determined 
feasibility, acceptability and initial efficacy, explored mediators and moderators of change, and 
informed the design for a larger randomized-control trial.  
The study was executed in two phases. The first phase consisted of intervention 
development and refinement. Intervention development was accomplished by conducting three 
focus groups with counselors and patients of a chemical dependency treatment center for women 
in which standard MBRP is a required part of programming. The purpose of these focus groups 
was to gather themes associated with trauma and substance use (e.g., avoidance of PTSD 
symptoms and function of substance use as it relates to PTSD, craving, guilt/shame, self-esteem). 
Information gathered after each Phase I focus groups was integrated into the standard MBRP 
protocol, along with aspects of CPT. Each protocol modification was presented to participants at 
subsequent Phase I focus group meetings for feedback and further refinement of the protocol 
until a final pilot adaptation was created. The pilot protocol underwent three revisions with 
participants’ feedback.  Phase II of the study consisted of a feasibility and initial efficacy trial 
using the refined intervention, and collection and assessment of feasibility and preliminary 
outcome data.  
Phase I: Intervention Development and Refinement 
 
Counselors and residents from the Volunteers of America Women’s Residential Center (WRC) 
were recruited for a series of focus groups to assist with the development and refinement of TI-
MBRP. Attending separate groups to ensure confidentiality, counselors and residents with 
previous experience in MBRP groups discussed how trauma-related symptoms and issues have 

manifested during MBRP sessions, and offered suggestions, reflections, and concerns regarding 
the appropriateness and acceptability of integration of trauma education and treatment 
approaches into MBRP. Information collected during these focus groups informed the initial 
adaptation of the intervention. 
Following these focus groups, protocol revisions were made by the Principal Investigator, 
and presented to counselors, residents, project mentors, and consultants for further input; a 
finalized protocol was developed, resulting in the TI-MBRP protocol and treatment manual used 
in the feasibility and initial efficacy trial.  
Trauma Informed- Mindfulness-Based Relapse Prevention. TI-MBRP is an eight-
session intervention that integrates trauma education and treatment approaches of CPT (Resick & 
Schnicke, 1993) into the standard MBRP protocol (Bowen, Chawla, & Marlatt, 2010). TI-MBRP 
honors the foundations of mindfulness meditation practice and cognitive-behavioral techniques 
of MBRP while introducing PTSD education and trauma processing surrounding five primary 
themes from CPT: Trust, Safety, Power and Control, Esteem, and Intimacy. Each TI-MBRP 
session included mindfulness practices that bring awareness to cognitive and behavioral 
processes underlying substance use, and how substance use functions as a mechanism to cope 
with PTSD symptoms. Sessions build upon content and practices in previous sessions, as 
participants become more aware of factors underlying their substance use and develop skills for 
responding to triggers or high-risk situations more effectively. The goal of TI-MBRP is to 
educate women in chemical dependency treatment settings about the interrelationship between 
substance use and trauma, support trauma processing with present-centered awareness via 
mindfulness-based exposure/response prevention practices, and prepare participants to skillfully 
respond to high-risk situations that increase risk of relapse.  

Phase II: Feasibility, Acceptability, and Initial Efficacy  
Trial Selection of participants and sampling. Participants were recruited from 
Hazelden Betty Ford Foundation (HBFF) and Lifeworks NW in the Portland metro area, which 
offer inpatient and intensive outpatient (IOP) treatment for SUD. Facilities under HBFF included 
one residential and one IOP clinic, and facilities under Lifeworks NW included two residential 
and one IOP clinic, totaling five clinics. Criteria for admittance into all facilities include a dual-
diagnosis for substance use disorder (SUD) and another mental health disorder. Approximately 
95% of women within these treatment facilities have a lifetime history of trauma, and 
approximately 88% are dually diagnosed with SUD and PTSD. As part of the standard care at 
the residential sites at HBFF and Lifeworks NW, patients undergo a detoxification treatment 
phase upon admission, followed by a “core learning” phase in which patients participate in group 
and individual therapy. They then move into a “transition phase” during which they prepare an 
aftercare plan, and secure both sober housing accommodations and partial employment and/or 
enrollment in an educational institute or trade school. Patients enrolled in HBFF and Lifeworks 
NW IOP have already undergone detoxification and are required to participate in groups, 
individual therapy and case management; treatment completion is between eight and 12 months.  
Patients in the core learning phase of residential treatment, and patients in IOP were 
recruited for the study. Patients in residential programs were physically stable after the 
detoxification phase, and able to participate in groups. The core learning phase of treatment 
within residential facilities typically begins two to three weeks after detoxification and lasts for 
approximately three months. Counselors and administrators of both residential and IOP clinics 
assisted with recruitment via word of mouth, flyers, and announcements at weekly group 
meetings. Data was monitored during the recruitment process and additional effort was made to 

recruit ethnic and racial minority groups when necessary. To be included in the study, 
individuals 1) were in the “core” phase of treatment or in IOP at LWNW or HBFF; 2) scored at 
least a four or higher on Breslau’s Short Screening Scale (Kimberling et al., 2006) for PTSD; 3)  
were between 18 and 70 years of age; 4) were fluent in speaking and reading English; and 5) had 
clearance from appropriate clinical staff. Individuals were excluded from study participation if 
they 1) endorsed active suicidality, hallucinations, or intense emotional lability; 2) had already 
participated in an MBRP group in current or past treatment; and 3) did not provide informed 
consent. Inclusion and exclusion criteria were assessed by the Inclusion/Exclusion Screening 
Tool.  
Sample size estimation. For a fully-powered, cluster-randomized design, a power 
analysis conducted via G*Power (Faul, Erdfelder, Lang, & Buchner, 2007) using α = .05, 
medium effect size across primary outcomes, mediators and moderators, a variance inflation 
factor of 2.55, and power level of .8 suggests a sample size of 437 participants (Donner, 1998). 
As a feasibility and initial efficacy trial, it is justified to recruit 10% of what is required of a fully 
powered clinical trial (Cocks & Torgerson, 2013; Treece & Treece, 1977); thus, we aimed to 
recruit 44 participants.  Due to high attrition rates (56%) at a 15-week follow-up from previous 
research at the Phase I clinical sites (Witkiewitz, 2014), we aimed to recruit 100 participants to 
secure a sufficient sample size at one-month follow-up powered to analyze primary outcome data 
at the end of intervention implementation. We aimed for an attrition rate of 40% or less due to 
the short duration of the study and greater ease in contacting participants at follow-up due to 
most participants’ residential and active IOP status. Mediators and moderators were not included 
in the power analysis due to the current study being a feasibility and initial efficacy trial, and the 

exploratory intention of examining mechanisms and moderators for a future, fully-powered 
study.  
Personnel involved in the study. The study PI and three advanced graduate-level 
Research Assistants (RAs) were responsible for pre- and post-intervention focus groups. TI-
MBRP manual adaptation was informed by input from CPT literatures, primary mentors, WRC 
staff and patients, and consultants. The PI and RAs delivered either TI-MBRP or Standard 
MBRP. In addition to three RAs who served as study interventionists, three additional graduate-
level RAs assisted with data collection at each assessment time, totaling six RAs throughout the 
study. Before implementation of the study, RAs responsible for implementing interventions 
completed an advanced teacher training in MBRP. Those who facilitated TI-MBRP attended the 
MBRP teacher training and an additional training in the TI-MBRP protocol. RAs responsible for 
implementing standard MBRP did not receive training in TI-MBRP to account for possible 
contamination effects by Standard MBRP interventionists. All RAs attended a training in 
implementing study protocol and procedures, which included training on recruitment and 
screening; assessment collection, entry, and storage; protocols for adverse events; and contacting 
participants throughout the study. Counselors from study sites were involved in the screening 
and recruitment of participants for the study. All study personnel completed a protection of 
human subjects course and HIPAA course prior to contact with any participants and involvement 
in the study.  
Procedures. Interested patients in IOP or in the core phase of residential treatment were 
screened for eligibility based on the Inclusion/Exclusion Screening Tool, BSSS (Kimberling et 
al., 2006), and had clearance from appropriate clinical staff. Individuals who signed up for the 
study were asked to complete the Inclusion/Exclusion Screening Tool and BSSS. If they 

endorsed a four or higher on the BSSS and met inclusion criteria, they were offered participation 
in the study. Interested patients also had clearance from their primary counselors to confirm they 
did not meet exclusion criteria. Eligible individuals were provided with a written and oral 
informed consent. The PI or RA reviewed the informed consent and answer any questions or 
concerns that individuals had about study procedures, confidentiality, data analysis, and 
dissemination of results. Once written informed consent was obtained, participants were notified 
of the group start date within one week of signing the consent form. Participants were asked to 
complete a battery of paper-and-pencil assessments within one week prior to the start of the first 
session. After assessments were completed, cohorts of participants were randomized to receive 
either Standard MBRP or TI-MBRP. A non-interventionist RA used computer randomization 
software to assign to cohorts to either Standard MBRP or TI-MBRP. Ten TI-MBRP and 
Standard MBRP groups were implemented simultaneously at five sites for maximization of 
participants within the given timeframe over a 12-month period.  
After the first Standard MBRP and TI-MBRP session, participants were provided with a 
CD player and CD with audio-recordings of guided meditation practices used in the intervention 
(i.e., body scan, breath awareness) to use daily as a part of their homework requirements. 
Cohorts randomized to the TI-MBRP group were given an additional CD with mindfulness 
practices administered only in the TI-MBRP course. 
Participants completed a post-course assessment battery within one week of the 
completion of the eight-session course, taking place over four weeks. They had access to 
doctoral level psychology graduate students and to their primary counselor to discuss any 
distressing feelings related to the study. 

One week after post-course assessments, participants were invited to participate in a 
focus group to discuss what was helpful about the intervention and what could be changed. 
Focus groups were audio-recorded, transcribed, and analyzed in NVivo Pro V12. Frequently 
discussed topics within focus groups were used to inform changes to the pilot protocol which 
will optimize interventions within TI-MBRP targeting craving, substance use and PTSD 
symptoms. 
One month after the completion of post-course assessments, participants were asked to  
complete a follow-up assessment battery. If participants were unable to be physically present to 
complete the follow-up assessment, they were offered a phone interview during which an RA 
administered self-report assessment measures orally.  
Participants were given a $20 gift card (not redeemable for alcohol, cigarettes, or lottery 
tickets) at completion of each of the first two assessments (i.e., baseline assessment, post-course 
assessment) and post-course focus group. A $40 gift card was provided at completion of the one-
month follow-up assessment. Total possible compensation for participation in the study was 
$100. 
Design and analyses. This study is an initial step in exploring the safety, feasibility, and 
acceptability of a novel adaptation to an evidence-based intervention. We employed a cluster-
randomized, mixed methods, repeated measures design to determine feasibility, acceptability, 
initial efficacy, and mediators and moderators for TI-MBRP for women with co-occurring SUD 
and PTSD. Data from this study will inform the ecological validity and any further modifications 
that need to occur to the adapted protocol before conducting a larger cluster-randomized trial 
(Leon, Davis, & Kraemer, 2011; Moore, Carter, Nietert, & Stewart, 2011). Furthermore, 
determining initial efficacy and mediators and moderators will inform whether integrating 

evidence-based trauma education and interventions into MBRP will reduce PTSD symptom 
severity and substance use indices in dually diagnosed women with PTSD-SUD more efficiently 
than SUD treatment alone, and inform which measures to test as mechanisms and moderators in 
a larger trial (Leon, Davis, & Kraemer, 2011). 
Paper-and-pencil, self-report measures used at baseline, post course, and follow-up 
assessment points, as well as records of attendance, were double-entered into SPSS 26.0 by RAs. 
Prior to conduction planned quantitative analyses, data was checked for normality (skew +/- 2, 
kurtosis +/-2), homogenetity (p<.05), and accuracy using the exploratory function in SPSS 
(Fields, 1999). Outliers were assessed by identifying studentized residuals greater than ± 3 standard 
deviations. Although missing data is expected in this population, Restricted Maximum 
Likelihood Estimations (RMLE) allow for all participants to be included in analyses even if they 
present with missing data.  
Feasibility and acceptability was assessed using multiple metrics. Based on completion 
rates of an RCT conducted at the Phase I clinical site (Witkiewitz et al., 2014), we assessed 
recruitment and retention rates, with a target rate retention of 60% or better. Participant overall 
course satisfaction was measured by the OCSS. Treatment dropout was monitored by tracking 
attendance at each session and information will be gathered from clinical sites to determine 
whether the participant dropped out of treatment altogether or the study. This will allow 
assessment of any systematic bias or characteristics of TI-MBRP drop-outs vs. course 
completers.  
To assess initial efficacy, Repeated Measures Analysis of Variance (RM ANOVA) was 
used to examine differences between TI-MBRP and Standard MBRP in substance use, craving, 
and PTSD symptoms over time. When an interaction effect was detected, an ANCOVA was used 

to determine the timepoint in which two conditions differed, controlling for baseline scores 
(Fields, 1999). Mediators and moderators were examined using PROCESS in SPSS 26.0 to help 
identify factors that explain or support change in the relationships between PTSD symptom 
severity and craving, and PTSD symptom severity and substance use.   
For Phase II qualitative data collection and analyses, ten one-hour long focus groups were 
audio recorded once participants completed either TI-MBRP or Standard MBRP. Women were 
asked eight questions to assist with the refinement of the pilot protocol (See Appendix . 
Questions were as follows: 
1. 
What was your overall experience like in this group? 
2. 
How did this class help with understanding the relationship between substance use and  
trauma? 
3. 
How did this class help with processing the impact of traumatic events on aspects of your 
life now?  
4. 
How was this group different or similar from other substance use and trauma groups you  
have completed in the past?  
5. 
Is there anything that you felt was missing from this program that would have enhanced 
your experience while taking this course? 
6. 
What aspects of the treatment did you find helpful and/or important in your recovery  
process? 
7. 
What aspects did you dislike and feel could be changed or taken out? 
8. 
Would you recommend this group to other women who have not taken it yet? 
9. 
How would you describe the group to other women who have not taken this group yet? 
10. 
Are there certain people you would not recommend this group to or think that this group  
would be inappropriate for? 
 
All audio recordings were transcribed by a third party company, TranscribeMe. Transcribed 
focus-group data were uploaded into NVivo 12 Pro and coded by the PI and two RAs.. A 
constant comparison analysis (Fram, 2013; Leech & Onwuegbuzie, 2011) was implemented to 
code relevant information pertinent to refining the pilot protocol of TI-MBRP, which is 
recommended for pilot qualitative research (Leech & Onwuegbuzie, 2007). Three coders went 
through several iterations of extracting themes from transcribed audio recordings on what 

women thought the most and least helpful aspects of the program were.