Amplification of Positivity for Alcohol Use

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
Laureate Institute for Brain Research, Inc.
Study ID
NCT06030154
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Therapy — BEHAVIORAL
    Cognitive Behavioral Therapy
  • Amplification of Positivity Therapy — BEHAVIORAL
    Amplification of Positivity Therapy
  • Surveys and Interviews — BEHAVIORAL
    Participants will answer questions regarding their mental and physical health as well as their substance use on the computer and in an interview format.

Study Details

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).

Key Dates

Start date
Sep 25, 2023
Status verified
Jul 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Amplification of Positivity Therapy
    AMP-A will involve 12, one-hour weekly therapy sessions completed one-on-one with a therapist. The sessions and between-session homework will focus on amplifying positive thoughts, emotions, and behaviors to address anxiety/depression and alcohol use.
  • Active Comparator: Cognitive Behavioral Therapy
    The CBT intervention will involve 12, one-hour weekly therapy sessions completed one-on-one with a therapist. The sessions and between-session homework will focus on monitoring of the relationship between thoughts, emotions, and alcohol use.

Primary Outcome Measure

Perceived acceptability and satisfaction of the intervention as measured with the Adherence and Acceptability Scale (AAS) [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Laureate Institute for Brain ResearchTulsaOklahoma74008
Robin L Aupperle, PhD
[email protected]
918-502-5155

Find similar trials in Tulsa, OK

By condition
Substance use disorderDepression
By specialty
Behavioral healthAddiction medicinePsychiatryMental health
By research site
Laureate Institute for Brain Research· Tulsa, OK

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