← Back to Search

Behavioral Intervention

Amplification of Positivity + Cognitive Behavioral Therapy for Alcoholism (AMP-A Trial)

N/A

Recruiting

Led By Robin L Aupperle, PhD

Research Sponsored by Laureate Institute for Brain Research, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 65 years old

Be older than 18 years old

Must not have

Non-correctable vision or hearing problems

Diagnosis of Schizophrenia spectrum, other psychotic disorders, or bipolar I disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to recruit up to 120 people with depression, anxiety, & alcohol use disorder to test a new psychosocial intervention & an existing one to understand how they affect symptoms & brain activity.

Who is the study for?

This trial is for English-speaking adults aged 18-65 with alcohol use disorder and depression or anxiety, scoring above certain thresholds on the PHQ-9 or OASIS. Excluded are those using drugs affecting brain function, engaged in other psychosocial treatments for substance use or mood/anxiety within recent weeks, with severe medical conditions, MRI contraindications (Phase 2), or requiring intensive alcohol disorder treatment.

What is being tested?

The study tests Amplification of Positivity Therapy (AMP-A) against Cognitive Behavioral Therapy (CBT) for people with both alcohol use disorder and depression/anxiety. Phase 1 refines AMP-A based on participant/clinician feedback. Phase 2 randomly assigns participants to either AMP-A or CBT to compare effectiveness via surveys/interviews and fMRI scans.

What are the potential side effects?

While traditional side effects associated with medications aren't expected here, participation may involve emotional discomfort due to discussing personal issues related to alcohol use, anxiety, and depression during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have vision or hearing issues that cannot be corrected.

Select...

I have been diagnosed with schizophrenia, a related psychotic disorder, or bipolar I.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and average of total scores from the following time points:2 weeks after starting treatment, post-treatment (average of 16 weeks after baseline assessment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of drinking days in the past month

Change in positive affect self-report measured with National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Positive Affect score

Perceived acceptability and satisfaction of the intervention as measured with the Adherence and Acceptability Scale (AAS)

Secondary study objectives

Change in Average drinks per drinking day

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Scale

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Amplification of Positivity TherapyExperimental Treatment2 Interventions

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.

Group II: Cognitive Behavioral TherapyActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surveys and Interviews

2016

N/A

~130

0 / 3Eligibility criteria met