Renewed Recovery: a Pilot Test of a Web-Based Mindfulness-Based Relapse Prevention Continuing Care Intervention for Alcohol Use Disorder

NCT06987526 | Recruiting

• 1 other identifier: PROJECT00011445
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to design, implement, and evaluate a pilot test of a web-based Mindfulness-Based Relapse Prevention (MBRP) continuing care intervention to support individuals with alcohol use disorder (AUD) exiting standard outpatient treatment. Guided by the Centre for eHealth and Wellbeing Research (CeHRes) roadmap, the project follows a structured framework for digital intervention development: (1) contextual inquiry, (2) value specification, (3) design, (4) operationalization, and (5) summative evaluation. Contextual inquiry is defined as gathering information from the intended users and the environment in which the technology will be implemented. The next step, value specification, is defined as the quantification of the values of the key stakeholders, where the user requirements for the technology and the most favorable solutions emerge. This process elaborates on what was discovered in the contextual inquiry step and an analytical hierarchy is conducted to assign quantifiable values to the stakeholders' priorities for the intervention. Design is the step defined as the process of building prototypes of the technology that fit with the values and requirements of the stakeholders, and then testing the prototype in realistic situations. Operationalization is the implementation of the intervention. The final step, summative evaluation, is the assessment of the intervention's impact. The research team plans to conduct a needs assessment (Aim 1a), develop (Aim 1b), implement (Aim 2a), and evaluate (Aim 2b) a pilot test of a web-based MBRP continuing care intervention, named "Renewed Recovery", targeting individuals exiting standard outpatient treatment for alcohol. Aim 1: Design a web-based mindfulness continuing care intervention. Aim 1a: Conduct a community needs assessment. To understand the need for such an intervention, semi-structured qualitative interviews with program administrators (n=3) from partnering substance use treatment facilities will be conducted (contextual inquiry). To better understand the recovery journey after exiting standard outpatient treatment, semi-structured interviews with individuals (n\~10) who have been in treatment more than once will be conducted (contextual inquiry). After interviewing the 2 stakeholder groups, a meeting will be held to determine their list of priorities for this project (value specification). Aim 1b: Develop the intervention website (design). The website for the intervention will be created by creating multiple wireframe iterations and presenting them to the stakeholders to determine the best formatting. The curriculum on the site will be modeled after the original MBRP curriculum. After coming to a consensus on the best version of the website, a usability test will be conducted of a newly created prototype with the same 10 individuals who identified as having been in treatment more than once. A quantitative survey will be employed and a focus groups will be held to assess the usability, equitability, enjoyability, and usefulness of the website. Aim 2: Implement and evaluate the pilot test at partnering treatment facilities. Aim 2a: Implement the pilot test of the web-based MBRP continuing care intervention (operationalization). After altering the intervention based on the usability test, the program will begin to be implemented. 30 people (3 groups of 10) will. Be recruited to participate in the intervention that will be 8 weeks in length (1 module per week, for a total of 8 modules), composed of a self-guided curriculum of text and videos, as well as two zoom sessions to practice meditating as a group. Aim 2b: Evaluate the pilot test to determine process and behavior outcomes (summative evaluation). To measure process outcomes, surveys will be employed asking about the usability, equitability, enjoyability, and usefulness of the website as well as their overall satisfaction with the intervention. Recruitment and retention rates will be another identifier of process outcomes. To measure behavior outcomes, participants will be given a multitude of measures at baseline to measure relapse, anxiety, depression, self-efficacy, coping mechanisms, social support, acceptance, mindfulness, and reactivity to triggers. Analysis of these measures will be done via multilevel modeling. These measures will also be given at the completion of the program and at 3 months after completion.

Conditions

Alcohol Use Disorder (AUD)

Keywords

alcohol use disorder; recovery; continuing care; web-based; mindfulness-based relapse prevention; addiction

Outcome Measures

Primary Outcomes (1)

• Alcohol consumption (Timeline Followback)

  Alcohol consumption will be assessed using the Timeline Followback (TLFB) method, a validated self-report instrument used to collect retrospective estimates of daily drinking.

  Baseline (program entry), 8 weeks (program completion), and 3-month follow-up

Secondary Outcomes (12)

• Substance Use (Timeline Followback)

  Baseline (program entry), 8 weeks (program completion), and 3-month follow-up

• Depression (Short Form 6a PROMIS)

  Baseline (program entry), 8 weeks (program completion), and 3-month follow-up

• Anxiety (Short Form 8a PROMIS)

  Baseline (program entry), 8 weeks (program completion), and 3-month follow-up

• Coping Behavior (Coping Strategies Inventory- Short Form)

  Baseline (program entry), 8 weeks (program completion), and 3-month follow-up

• Alcohol Cravings (Penn Alcohol Craving Scale)

  Baseline (program entry), 8 weeks (program completion), and 3-month follow-up

Study Arms (1)

Renewed Recovery Pilot Test

EXPERIMENTAL

Participants will complete an 8-week web-based Mindfulness-Based Relapse Prevention program delivered asynchronously. Each weekly module includes educational content, mindfulness exercises, and videos. In weeks 3 and 6, participants will also attend a live Zoom session led by the study's Co-Investigator for group meditation practice. Quantitative questionnaires will be delivered at program entrance, program completion, and 3 months post-program completion. A focus group will also be held at program completion. Prior to implementation, the intervention will be refined based on feedback from a usability test with individuals who have lived experience. The intervention content will be informed by a community needs assessment of treatment providers and individuals with AUD.

Behavioral: Mindfulness-Based Relapse Prevention

Interventions

Mindfulness-Based Relapse Prevention BEHAVIORAL

Renewed Recovery is a web-based Mindfulness-Based Relapse Prevention (MBRP) continuing care intervention adapted from the original MBRP curriculum by Bowen et al. It consists of 8 weekly modules designed to teach mindfulness and relapse prevention strategies for individuals with alcohol use disorder. The intervention includes educational content, guided meditations, and practical exercises. Modules are delivered asynchronously online, supplemented by two live Zoom sessions for group meditation practice. The purpose of the curriculum is to teach mindfulness and relapse prevention techniques to the participants with the aim of reducing the risk for relapse. The module titles are as follows: (1) Automatic Pilot and Relapse, (2) Awareness of Triggers and Craving, (3) Mindfulness in Daily Life, (4) Mindfulness in High Risk Situations, (5) Acceptance and Skillful Action, (6) Seeing Thoughts as Thoughts, (7) Self-Care and Lifestyle Balance, and (8) Social Support and Continuing Practice.

Also known as: MBRP

Renewed Recovery Pilot Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Currently leaving standard outpatient treatment within 1 week of the scheduled intervention start date, or has completed standard outpatient treatment within the past month
• Has access to the internet
• Scored 8 or above on the Alcohol Use Disorders Identification Test (AUDIT), or self-identifies as having been in treatment for alcohol use

You may not qualify if:

• Currently experiencing psychosis
• Currently experiencing dementia
• Does not have access to the internet
• Has not recently completed or left standard outpatient treatment within the specified timeline
• Does not meet criteria for alcohol use disorder

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (2)

Rescue Mission of Middle Georgia

Macon, Georgia, 31220, United States

RECRUITING

Project Adam

Winder, Georgia, 30680, United States

ACTIVE NOT RECRUITING

Related Publications (2)

• van Gemert-Pijnen JE, Nijland N, van Limburg M, Ossebaard HC, Kelders SM, Eysenbach G, Seydel ER. A holistic framework to improve the uptake and impact of eHealth technologies. J Med Internet Res. 2011 Dec 5;13(4):e111. doi: 10.2196/jmir.1672.

  PMID: 22155738 BACKGROUND

• Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.

  PMID: 19904665 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Jessica L Muilenburg, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily T Vinson, MPH

CONTACT

706-308-8141; eltownsend97@uga.edu

Jessica L Muilenburg, PhD

CONTACT

706-296-8509; jlm@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a single-group, pre-post design to pilot test the feasibility, acceptability, and preliminary effects of a web-based Mindfulness-Based Relapse Prevention (MBRP) continuing care intervention ("Renewed Recovery") for individuals with alcohol use disorder (AUD) exiting standard outpatient treatment. Thirty participants will be enrolled and complete an 8-week self-guided web-based program. Assessments will be conducted at baseline, post-intervention, and 3-month follow-up.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: May 14, 2025
• Primary Completion: March 22, 2026
• Study Completion: May 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
• Access Criteria: Data will be made available to qualified researchers conducting ethically approved research. Requests will be reviewed by the study team for scientific merit and compliance with ethical standards.

Locations

US (2)