Clinical trial NCT06987526: Renewed Recovery: a Pilot Test of a Web-Based Mindfulness-Based Relapse Prevention Continuing Care Intervention for Alcohol Use Disorder
Official title: Renewed Recovery: a Pilot Test of a Web-Based Mindfulness-Based Relapse Prevention Continuing Care Intervention for Individuals With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Keywords: alcohol use disorder
recovery
continuing care
web-based
mindfulness-based relapse prevention
addiction
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Alcohol consumption (Timeline Followback)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
Secondary outcomes:
measure: Substance Use (Timeline Followback)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Depression (Short Form 6a PROMIS)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Anxiety (Short Form 8a PROMIS)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Coping Behavior (Coping Strategies Inventory- Short Form)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Alcohol Cravings (Penn Alcohol Craving Scale)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Mindfulness (5 Facet Mindfulness Questionnaire)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Acceptance (Acceptance and Action Questionnaire II)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Recovery Related Self-Efficacy (Alcohol Abstinence Self-Efficacy Scale)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Triggers (Transaddiction Craving Triggers Questionnaire)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Social Support (Social Provisions Scale)
timeFrame: Baseline (program entry), 8 weeks (program completion), and 3-month follow-up
measure: Program Satisfaction (Client Satisfaction Questionnaire)
timeFrame: Program completion
measure: Website Satisfaction (Systems Usability Scale)
timeFrame: Usability Test (formative/ Aim 1B) & Program completion (pilot test/Aim 2A)
Other outcomes:
Locations:
city: Macon
country: United States
facility: Rescue Mission of Middle Georgia
state: Georgia
city: Winder
country: United States
facility: Project Adam
state: Georgia
Study officials:
affiliation: University of Georgia
name: Jessica L Muilenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.