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Recruiting NCT06030154

Amplification of Positivity for Alcohol Use

Trial Parameters

Condition Alcohol Use Disorder
Sponsor Laureate Institute for Brain Research, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-09-25
Completion 2026-07
Interventions
Cognitive Behavioral TherapyAmplification of Positivity TherapySurveys and Interviews

Brief Summary

The proposed study consists of two phases. During Phase 1, the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention. Based on their input and clinician input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT) intervention. Up to 100 participants will be recruited in order to reach a target of N=60. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, functional disability, and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI).

Eligibility Criteria

Inclusion Criteria: 1. Age between 18 and 65 years old. 2. Meeting diagnostic criteria for alcohol use disorder 42 according to the DSM-5. 3. Reports that they would like to seek treatment for AUD and that AUD is one of the primary challenges they would like to address in treatment. 4. Phase 1: Significant depression or anxiety symptoms as indexed by scoring Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Phase 2: Significant depression or anxiety symptoms as indexed by scoring ≥ 55 on either of the NIH PROMIS ((Patient-Reported Outcomes Measurement Information System) Depression and/or Anxiety scales. 5. Below normative levels of positive affect as indexed by PROMIS Positive Affect \<50. 6. Able to provide written informed consent. 7. Have sufficient proficiency in the English language to understand and complete interviews, questionnaires, and all other study procedures. Exclusion Criteria: 1. Unwillingness or inability to co

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