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Life sciences · Interventional Study
ClinicalTrials.gov · October 14, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06030154). This is a study registration, not published results. Lead sponsor: Laureate Institute for Brain Research, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Alcohol Use Disorder, Anxiety, Depression. Interventions: BEHAVIORAL: Cognitive Behavioral Therapy; BEHAVIORAL: Amplification of Positivity Therapy; BEHAVIORAL: Surveys and Interviews. Primary outcome measures: Perceived acceptability and satisfaction of the intervention as measured with the Adherence and Acceptability Scale (AAS) , Average of total scores from the following time points: pre-treatment, 2 weeks after starting treatment, 6 weeks after starting treatment, and at post-treatment (average of 16 weeks after baseline assessment); Change in positive affect self-report measured with National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Positive Affect score , Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment); Change in number of drinking days in the past month , Trajectory of change from pre-treatment to post-treatment (last time point assessed on average 16 weeks after baseline assessment). 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).