RecruitingNot ApplicableNCT06030154

Amplification of Positivity for Alcohol Use

Developing and Evaluating a Positive Valence Treatment for Alcohol Use Disorder With Anxiety or Depression


Sponsor

Laureate Institute for Brain Research, Inc.

Enrollment

100 participants

Start Date

Sep 25, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new therapy called "Amplification of Positivity" to help people with alcohol use disorder (AUD) by improving their mood and emotional well-being alongside standard treatment. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with alcohol use disorder and want treatment for it - You have significant depression or anxiety symptoms - You are able to read and speak English - You have access to a phone **You may NOT be eligible if...** - You have schizophrenia, bipolar I disorder, obsessive-compulsive disorder, or an eating disorder - You have active plans to attempt suicide within the next month - You have serious unstable medical conditions affecting the heart, liver, kidneys, or lungs - You are currently taking medications that affect brain function (like antipsychotics or naltrexone) started within the past 6 weeks - You are currently enrolled in another alcohol or mood/anxiety treatment program started in the last 12 weeks - You are pregnant, a prisoner, or under 18 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive Behavioral Therapy

Cognitive Behavioral Therapy

BEHAVIORALAmplification of Positivity Therapy

Amplification of Positivity Therapy

BEHAVIORALSurveys and Interviews

Participants will answer questions regarding their mental and physical health as well as their substance use on the computer and in an interview format.


Locations(1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

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NCT06030154


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