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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

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

AMP-A Trial 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.Check my eligibility

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.See study design

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.

AMP-A Trial 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.

AMP-A Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

AMP-A 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Laureate Institute for Brain Research, Inc.Lead Sponsor

50 Previous Clinical Trials

5,245 Total Patients Enrolled

17 Trials studying Depression

2,557 Patients Enrolled for Depression

University of California, San DiegoOTHER

1,122 Previous Clinical Trials

1,520,944 Total Patients Enrolled

29 Trials studying Depression

56,078 Patients Enrolled for Depression

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,345 Total Patients Enrolled

25 Trials studying Depression

7,969 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 18 and over being accepted into this research experiment?

"The required age range for participants is 18-65, as listed in the study's enrollment qualifications."

Answered by AI

What criteria must be met to become part of this research endeavor?

"To qualify for this research, participants must have been diagnosed with depression and should be between the ages of 18-65. A total of 100 individuals will be enrolled in the study."

Answered by AI

Are researchers still enrolling participants for this trial?

"According to the public records hosted on clinicaltrials.gov, this study is seeking participants at present time. The trial was first documented on September 1st 2023 and has since been modified as recently as September 6th of that same year."

Answered by AI

What is the capacity of volunteers for this clinical experiment?

"Affirmative. Clinicaltrials.gov records indicate that this medical trial, which was first posted on September 1st 2023, is actively recruiting individuals. A total of 100 volunteers are needed from a single clinical site."

Answered by AI

What is the objective of this research?

"The main aim of this clinical trial is to measure the alteration in a patient's positive affect via the NIH PROMIS Positive Affect score. This assessment will be taken pre-treatment, after 2 weeks of treatment initiation, and 6 weeks later with an average post-treatment evaluation at 16 weeks. Secondary outcomes include changes in Patient Reported Outcome Measurement Information System (PROMIS) Depression Scale scores from 0-100 where higher numbers indicate more severe symptoms, shifts in Sheehan Disability Scale (SDS) levels ranging from 0 to 30 which correlate with heightened disability states, as well as fluctuations in loneliness utilizing the NIH Toolbox L"

Answered by AI

Recent research and studies

Depression and AnxietyJournal

Upregulating the Positive Affect System in Anxiety and Depression: Outcomes of a Positive Activity Intervention

Taylor, Charles T., Sonja Lyubomirsky, and Murray B. Stein. 2017. “Upregulating the Positive Affect System in Anxiety and Depression: Outcomes of a Positive Activity Intervention”. Depression and Anxiety. Wiley. doi:10.1002/da.22593.

clinicaltrials.govStudy

Amplification of Positivity for Alcohol Use

2023. "Amplification of Positivity for Alcohol Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06030154.