TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study

Alcohol Use Disorder Clinical Trial

— THRIVE  

Official title:

Mindfulness-Based Relapse Prevention as Video Conferencing Continuing Care to Promote Long Term Recovery From Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074341
• Other study ID #: 2212028742
• Secondary ID: R01AA031159
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: Katie Witkiewitz, PhD
• Phone: 505-226-5252
• Email: katiew[@]unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.

Description:

The goal of this study is to examine the effectiveness of mindfulness-based relapse prevention (MBRP) groups delivered via Zoom in promoting whole-person recovery from alcohol use disorder, and to examine how MBRP affects mechanisms of behavior change based on neurobiologically-informed addiction cycle domains. The investigators will use a hybrid effectiveness-implementation design to prospectively test the effectiveness of MBRP, as well as identify barriers and facilitators of MBRP group participation to inform future implementation of MBRP continuing care. Individuals (n=430) who have recently engaged in a change attempt to stop or reduce their drinking (via treatment or self-change) will be randomized to either MBRP groups via Zoom or referral to online mutual support. Participants will complete measures of psychosocial functioning, alcohol and other drug use, addiction cycle domains, and previously established predictors of recovery every 6 months for 3 years. Using a mixed methods design in the MBRP group, the investigators will examine facilitators and barriers to participation and engagement in MBRP, and assess the reach, effectiveness, adoption, implementation, and maintenance of MBRP via Zoom as continuing care in communities nationwide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: July 31, 2028
• Est. primary completion date: January 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years old

• Received AUD treatment or made a self-change attempt to reduce or stop drinking in the past 3 months or is interested in reducing or stopping drinking

• Meet criteria for a current AUD

• Engaged in heavy drinking (more than 14 standard drinks per week or more than 4 drinks on a single day for men and more than 7 drinks per week or more than 3 drinks on a single day for women) in the past 6-months

• Able to understand all study procedures and able to consent in English or Spanish.

• Be willing to use a personal smart phone or tablet that is connected to the internet, or being willing to use a study-provided tablet

• Have access to a valid U.S. mailing address for receiving dried blood spot card or blood collection device.

Exclusion Criteria:

• Current symptoms of psychosis or mania.

• Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol-Related Disorders
• Alcoholism

Intervention

Behavioral:
• Mindfulness-based relapse prevention
Mindfulness-based relapse prevention (MBRP) is a group-based treatment to provide individuals with skills intended to foster increased awareness of triggers, destructive habitual patterns, and "automatic" reactions to triggering experiences. Mindfulness practices in MBRP are designed to help individuals pause, observe present experience, and bring awareness to the range of choices available in every moment. Through MBRP individuals learn to respond in ways that serve them, rather than react in ways that are detrimental to their health and happiness.
• Online Mutual Support Groups
Mutual support groups are free, peer-led organizations that are designed to help individuals with substance use disorders and other addiction-related problems. Mutual support groups often focus on communication and exchange of addiction and recovery experience and skills. Individuals participate in activities that engage, educate, and support patients recovering from substance use disorder from others facing similar challenges. Mutual help organizations that will be offered as referrals include: Alcoholics Anonymous (AA), In The Rooms, and SMART Recovery.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from AUD	Recovery is a binary (yes/no) outcome defined by achieving all three of the following: (1) Remission from Diagnostic and Statistical Manual, 5th edition alcohol use disorder (AUD) based on an 11-item AUD symptom checklist (endorsing 0 or 1 item is AUD remission); (2) Cessation of heavy drinking (defined as not engaging in heavy drinking with heavy drinking defined as 4 or more drinks per occasion for females, and 5 or more drinks per occasion for males, measured by the Timeline Follow-Back); and (3) Improvements in functioning and well-being as measured by higher score on the World Health Organization Quality of Life domain scores (each of 26 items scored from 1 to 5 on a response scale, which are then transformed linearly to a 0-100-scale) and the 36-item Short Form Health Survey Mental Health Component Score (scored on a 0-100 scale). Recovery is achieved if remission, cessation of heavy drinking, and improvements in functioning and well-being are achieved.	Change from baseline to three year follow-up period
Secondary	Reduction in World Health Organization risk drinking levels	The Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days will be used to calculate the World Health Organization risk levels based on sex specific grams of alcohol consumed per day in the 30 days prior to the assessment, with levels defined as: low risk (0-20 females/0-40 males), moderate risk (21-40 females, 41-60 males), high risk (41-60 females, 61-100 males), and very high risk (61+ females/100+ males) we will examine those who achieve at least a 1-level and at least a 2-level reduction in risk drinking levels. The reference group for the 1-level reduction is no change or increase in WHO risk drinking level and the reference group for the 2-level reduction is 1-level reduction, no change, or increase in WHO risk drinking level. The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36.	Change from baseline to three year follow-up period
Secondary	PROMIS Alcohol Negative Consequences	The Patient-Reported Outcomes Measurement Information System (PROMIS®) includes 7 items scored from never=1 to almost always=5 that assess negative consequences from alcohol use (e.g., I used poor judgment when I drank). The PROMIS Negative Alcohol Consequences measure will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more negative consequences.	Change from baseline to three year follow-up period
Secondary	PROMIS Preference Score (PROPr)	PROPr combines scores from 7 PROMIS domains (cognitive function, depression, fatigue, pain interference, physical function, ability to participate in social roles and activities, and sleep disturbance) into a single health utility score. The PROMIS PROPr will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate better health.	Change from baseline to three year follow-up period
Secondary	Penn Alcohol Craving Scale	Five item measure of overall craving for alcohol. Responses range from 0 to 6 where 0 represents the absence of the specific craving symptom in the item, and 6 represents the maximum intensity or frequency of the craving symptom in the item. The Penn Alcohol Craving Scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores on the Penn Alcohol Craving Scale reflect more severe alcohol craving.	Change from baseline to three year follow-up period
Secondary	Alcohol Use Disorder symptoms	Total number of symptoms endorsed (yes or no) on an 11-item checklist of the symptoms of alcohol use disorder experienced in the past 12-months (baseline) and past 6-months (at 6-month follow-up assessments). The Alcohol Use Disorder Symptom checklist will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more symptoms of alcohol use disorder.	Change from baseline to three year follow-up period
Secondary	Reduction in percent heavy drinking days	Percent heavy drinking days will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of occasions of daily heavy drinking (defined as 4 or more drinks for females and 5 or more drinks for males), and the percent heavy drinking days will be calculated as the number of heavy drinking days in the past 90 days divided by the total number of days in that time period (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher percent heavy drinking days indicate more heavy drinking occasions in a 90-day period.	Change from baseline to three year follow-up period
Secondary	Reduction in drinks per drinking day	Drinks per drinking day will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of drinks consumed on each drinking day, and the number of drinks per drinking drinking days will be calculated as the total number of drinks consumed in the past 90 days divided by the total number of days in that time period when drinking occurred (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher drinks per drinking day indicates greater intensity of drinking in a 90-day period.	Change from baseline to three year follow-up period
Secondary	Reduction in percent drinking days	Percent drinking days will be calculated using the Timeline Follow-Back calendar method of assessing standard alcohol drinks consumed each day over the past 90 days. This measure will be used to identify the total number of occasions of drinking, and the percent drinking days will be calculated as the number of drinking days in the past 90 days divided by the total number of days in that time period (typically 90 days, unless some days are missing). The Timeline Follow-Back Calendar will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher percent drinking days indicate greater frequency of drinking in a 90-day period.	Change from baseline to three year follow-up period
Secondary	World Health Organization Quality of Life (WHOQOL - BREF) Measure	The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The WHOQOL - BREF will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores on the WHOQOL-BREF reflect greater quality of life.	Change from baseline to three year follow-up period
Secondary	Substance Use Moderation Self-Efficacy Scale (SUM-SES)	The SUM-SES is a 12-item questionnaire that asks participants to indicate on a 0% to 100% scale regarding how confident they are that they would be able to resist drinking beyond their limit in a given situation. The SUM-SES will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores on the SUM-SES reflect greater confidence to resist drinking beyond one's limit.	Change from baseline to three year follow-up period
Secondary	Addiction Cycle - Negative Emotionality Scale	The negative emotionality domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing negative emotions. The Negative Emotionality Scale consists of 4 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing negative emotions. The Addiction Cycle Negative Emotionality scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate a greater tendency to be tempted to drink in situations characterized by negative emotions.	Change from baseline to three year follow-up period
Secondary	Addiction Cycle - Incentive Salience Scale	The incentive salience domain of the addiction cycle is characterized by temptation to drink in situations when the person is experiencing rewarding or social pressure to drink. The Incentive Salience Scale consists of 4 items scored on a scale from 1=not at all tempted to 5=extremely tempted to drink when experiencing rewarding, craving, or social situations. The Addiction Cycle Incentive salience scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate a greater tendency to be tempted to drink in situations characterized by reward, craving, and social pressure.	Change from baseline to three year follow-up period
Secondary	Addiction Cycle - Executive Function Scale	The executive function domain of the addiction cycle is characterized by loss of control over drinking. The Executive Scale consists of 1 binary yes/no item ("After taking one or two drinks, can you usually stop?") and 4 items scored on a scale from 1=indicating more control over drinking to 5=indicating loss of control over drinking. The Addiction Cycle Executive Function scale will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more impaired executive function and greater loss of control over drinking.	Change from baseline to three year follow-up period
Secondary	Purpose in Life test	The Purpose in Life test is a 20 item measure of experiencing meaning and purpose in one's life, with each item assessed on a 1 (lack of meaning) to 7 (full of meaning) Likert-type scale. The Purpose in Life test will be administered once at baseline, and at follow-up months 6, 12, 18, 24, 30, and 36. Higher scores indicate more meaning and purpose in life.	Change from baseline to three year follow-up period