Comprehensive Process Model of AA-related Behavior Change

NCT04618653 | Active Not Recruiting DMC

• 1 other identifier: 1525759-3
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

Alcoholics Anonymous (AA) is one of the most popular resources for dealing with alcohol-related problems, and 12-step therapy (TS), based upon AA doctrine and practice, is one of the prevailing alcohol treatment approaches in the United States. Two large multisite trials, one high in internal validity and the second high in external validity came to the same conclusion, TS was equally effective as more research supported therapies, and may actually be superior when total abstinence is the treatment goal. A primary objective of TS is to facilitate AA affiliation and strong evidence suggests that this aim is a major factor accounting for the effectiveness of TS. High priority has therefore been assigned to the investigation of what actually occurs in AA, with a special focus on identifying prescribed AA behaviors and processes that are predictive of drinking reduction. The guiding assumption of these efforts is that the key to improve TS is to first understand AA better. To this end, this study will generate, for the first time, a comprehensive and definitive process model of AA-related behavior change. This objective will be realized through the highly innovative use of EMA data collection among early AA affiliates. Using real-time daily data, aim 1 will determine if four MOBC identified by AA researchers (gains in social support, increased abstinence self-efficacy, spiritual practices, and negative urgency) mediate the linkage between three types of AA prescribed behaviors and drinking outcome. Noteworthy, these analyses will include the first rigorous testing of six of seven of criteria to confirm (or reject) that these four statistical mediators are MOBC. Aim 2 will investigate whether the actions of the AA active ingredients on mediators (a path) and the actions of the mediators (b path) are constant over time or, alternatively, if there are critical periods of influence. Last, aim 3 will determine if the four MOBC operate differently across distinct subpopulations. To achieve study aims, we propose a two-group randomized longitudinal study (N = 190). In one group (n = 130) we will collect 6-months of continuous EMA data, allowing us to examine near real-time associations between AA active ingredients in three domains, four MOBC, and drinking. In tandem, we will also conduct in-person interviews at baseline, 3, and 6-months. Assessment reactivity is a concern, especially so because this will be the first study to use EMA in addition to in-person interviews in AA research. We will therefore include a traditional fixed assessment group (n = 60) also interviewed at baseline, 3, and 6-months to identify potential measurement biases introduced in our innovative approach. Achievement of study aims will generate the first empirically validated AA process model that will inform TS with critical information for improving treatment outcomes.

Conditions

Alcohol Use Disorder (AUD)

Outcome Measures

Primary Outcomes (2)

• Change in Percent abstinent days at baseline, 3 months and six-months

  calculated as the number of abstinent days in an assessment window divided by the total number of days in an assessment window

  baseline, 3, and 6, months

• Change in daily Percent abstinent days baseline to six-months

  mobile device will provide daily reported drinking

  baseline to six-months

Study Arms (1)

Early AA Attenders with Alcohol Use Disorder

observational study that includes three fixed assessments (Baseline, 3, and 6-month). Subset of participants will also provide daily EMA data.

Other: assessment only

Interventions

assessment only OTHER

Three assessment will include computerized assessments, interviews, and subset will provide daily reports of prescribed AA behaviors and practices

Early AA Attenders with Alcohol Use Disorder

Eligibility Criteria

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

Study Population

community sample

You may qualify if:

• ADS score ≥ 8 (past 12 months)
• alcohol use, past 4 months
• attended ≥ 1 AA meeting, past three months
• ≥ 18 years of age
• speak and read English at the sixth grade level.

You may not qualify if:

• ≥ 4 months of continuous AA attendance (lifetime), with continuous defined as attending at least 1 AA meeting per week over a 4-month period
• admitted into inpatient or outpatient substance abuse treatment in the prior 12 months (currently seeking treatment will not be a basis to exclude)
• unable to provide the names of two locators
• active psychosis or a condition impairing ability to provide informed consent
• pending legal convictions involving ≥ 90-days incarceration
• plans to relocate to another state
• ≥ 3 formal treatment experiences (lifetime) for substance abuse
• ≥ 12 months of continuous abstinence from alcohol (lifetime) initiated in response to perceived alcohol-related problems.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Center on Alcohol, Substance Use, and Addictions (CASAA)

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• JEFFREY TONIGAN, phd

  UNIVERSITY OF NEW MEXICO (CASAA)

  PRINCIPAL INVESTIGATOR

• Matthew r Pearson, phd

  UNIVERSITY OF NEW MEXICO (CASAA)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CASAA Director

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 6, 2020
• Study Start: September 28, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)