Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience
Table 2
Core Components of treatment fidelity-related assessment and enhancement methods.
Treatment fidelity: core components
Recommended elements
Implementation of the recommended elements in the study
() Study/intervention design: rooted in a conceptual model or existing clinical practice and enabling hypothesis testing
Theoretical framework
Conceptual background
Theoretical framework supporting MM as a therapy for substance use disorders was published [8, 9, 12, 16] The study intervention was adapted from the existing program developed for adults with substance use disorders [6]
Intervention goals
Reduction of alcohol relapse (primary aim) and drinking-related consequences (secondary aim)
Comparison arms (i) Treatment dose across the study arms (ii) Treatment dose within each arm
MM + usual care versus usual care alone (wait-list control) (i) Assessment activities were the same across the two arms; treatment dose was not equal (only the MM group received the intervention) (ii) Adherence to treatment protocol was promoted with the goal of maximum treatment dose among the MM group participants
Participant characteristics
Alcohol-dependent adults in early (2–14 weeks) recovery, engaged in the outpatient treatment (≥2 weeks) for alcohol dependence
Therapist, team, environment characteristics
Therapist characteristics
Background in mental health and substance abuse-related counseling, with experience in applying behavioral therapies for addictive disorders; personal MM practice, including instruction
Team structure
At least two team members (therapist + research staff) were present at each intervention session to monitor and enhance participant adherence and safety of the personnel and participants, collect data, and assist the therapist
Environment
The intervention was delivered in a large, quiet hospital-based conference room (central location; convenient, free street parking)
Manual development
Program/session model
The intervention was patterned after MBRP [6], which, in turn, was patterned after MBCT [5] and MBSR [4]; it consisted of eight weekly two-hour therapist-led group sessions
Minimum dose
Attendance of at least 4 intervention sessions
Corrective feedback
Experience from two consecutive uncontrolled pilot trials [17]; and and expert input allowed to refine the methods, including the intervention manual, prior to implementing them in the RCT
Planning for the implementation setbacks
Back-up therapist
A second therapist was selected and trained to be available as back-up for the primary therapist
Session rescheduling
Protocol was developed in advance for when to cancel/reschedule the intervention sessions (e.g., inclement weather)
Safety protocol
All research personnel were trained by the PI in the safety protocol steps, outlined in a binder present at each session, in case of worrisome medical or mental health symptoms in the study participants; at least two study team members needed to be present at each session; the sessions were held in a hospital conference room guaranteeing a proximity of the emergency and security services
() Training of the therapists: ensuring appropriate implementation of the intervention
Therapist Training
Standardized training
Primary therapist was trained by the PI according to the intervention manual, then delivered the intervention in two pilot trials. She then received additional protocol-driven, day-long training from the PI prior to delivering the intervention in the RCT; the first study intervention (eight sessions) was directly observed by the PI. The back-up therapist received a protocol-driven training and then cofacilitated delivery of one intervention (eight sessions) with the primary therapist The protocolized training included a didactic portion on alcohol addiction, relapse prevention, and mindfulness meditation; manual-driven review and discussion of each session’s content; and role-playing; the therapists created flash cards outlining each session’s main points to enhance adherence to the intervention manual
Booster training/certification
The therapists completed additional formal training (5-day residential course) in MBRP, offered by its developers
() Monitoring and enhancement of intervention delivery: ensuring it is implemented as intended
Control for provider differences
Therapist effect
One (primary) therapist delivered the intervention during the whole study; a second (back-up) therapist was available as needed
Adherence to treatment protocol
Therapist adherence and competence
The therapist adherence and competence were scored with the modified MBRP-AC scale: (a) after each intervention session by the researcher present at the session; and (b) by a PI-trained auditor who audited selected audio-recorded sessions; all intervention sessions were audio-recorded
Corrective feedback
Feedback on therapist adherence and competence
Suboptimal scores of the MBRP-AC scale were discussed with the therapist by the PI
Participant feedback
Participant feedback on the intervention content, delivery, and settings was actively sought throughout the study; no modifications to the intervention protocol were needed as based on this feedback
() Intervention receipt and enactment monitoring: monitoring and improving participant understanding and performance of the taught skills and their appropriate application in real-life settings
Treatment adherence
Session attendance
Strategies to promote participant adherence to session attendance: reminder phone calls; transportation assistance; scheduling of the intervention sessions in late afternoon to accommodate typical work schedule; snacks at the intervention sessions; reaching out by the study coordinator to those who missed a session
Home practice
Strategies to promote participant home practice: discussion at the intervention sessions of barriers, facilitators and experiences related to MM practice
Treatment receipt
Understanding of the concepts taught during the sessions
Inquiry by the therapist about questions, comments or problems at each session; therapist-facilitated discussion among the session participants about session-specific core topics and a review session-specific home practice
Ability to use the taught skills
Linking of the taught skills to relapse prevention during each session; practicing implementation of the taught skills in hypothetical high-risk situations during the session; discussion and review of the skill implementation at home
Treatment enactment
Ensure use of the taught skills in appropriate life settings
Discussion and review of the skills and their application to specific situations at home; logs of home practice; survey on treatment satisfaction and experiences at the last intervention session; Global Assessment of Treatment survey at the 8-week follow-up visit
