NCT06987526 · University of Georgia
Renewed Recovery: a Pilot Test of a Web-Based Mindfulness-Based Relapse Prevention Continuing Care Intervention for Alcohol Use Disorder
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Macon, Georgia
- Winder, Georgia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 30, 2025 · Source of record for eligibility and locations