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Comprehensive Process Model of AA-related Behavior Change

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ClinicalTrials.gov Identifier: NCT04618653
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Scott Tonigan, University of New Mexico

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.

Condition or disease Intervention/treatment
Alcohol Use Disorder (AUD) Other: assessment only

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Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Comprehensive and Dynamic AA Process Model: One Day at a Time
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Three assessment will include computerized assessments, interviews, and subset will provide daily reports of prescribed AA behaviors and practices




Primary Outcome Measures :
  1. Change in Percent abstinent days at baseline, 3 months and six-months [ Time Frame: baseline, 3, and 6, months ]
    calculated as the number of abstinent days in an assessment window divided by the total number of days in an assessment window

  2. Change in daily Percent abstinent days baseline to six-months [ Time Frame: baseline to six-months ]
    mobile device will provide daily reported drinking



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

Inclusion criteria:

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

Exclusion Criteria:

  1. ≥ 4 months of continuous AA attendance (lifetime), with continuous defined as attending at least 1 AA meeting per week over a 4-month period
  2. admitted into inpatient or outpatient substance abuse treatment in the prior 12 months (currently seeking treatment will not be a basis to exclude)
  3. unable to provide the names of two locators
  4. active psychosis or a condition impairing ability to provide informed consent
  5. pending legal convictions involving ≥ 90-days incarceration
  6. plans to relocate to another state
  7. ≥ 3 formal treatment experiences (lifetime) for substance abuse
  8. ≥ 12 months of continuous abstinence from alcohol (lifetime) initiated in response to perceived alcohol-related problems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618653


Contacts
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Contact: JEFFREY TONIGAN, phd 5056100932 jtonigan@unm.edu
Contact: Matthew r Pearson, phd 7572921799 mateo.pearson@gmail.com

Locations
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United States, New Mexico
Center on Alcohol, Substance Use, and Addictions (CASAA) Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: JEFFREY TONIGAN, phd    505-610-0932    jtonigan@unm.edu   
Contact: Matthew r pearson, phd    7572921799    mateo.pearson@gmail.com   
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: JEFFREY TONIGAN, phd UNIVERSITY OF NEW MEXICO (CASAA)
Study Director: Matthew r Pearson, phd UNIVERSITY OF NEW MEXICO (CASAA)
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Responsible Party: Scott Tonigan, CASAA Director, University of New Mexico
ClinicalTrials.gov Identifier: NCT04618653    
Other Study ID Numbers: 1525759-3
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders