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Behavioural Intervention

Acceptance and Commitment Therapy for Alcohol Consumption in People with HIV

N/A

Waitlist Available

Research Sponsored by Syracuse University

Eligibility Criteria Checklist

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

Must have

On HIV treatment and 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study if a therapy called acceptance and commitment therapy (ACT) can help reduce alcohol use and symptoms of depression, anxiety, and stress in people with HIV who drink too much. Previous

Who is the study for?

This trial is for adult individuals living with HIV who drink alcohol at unhealthy levels. Participants must be willing to undergo therapy sessions over the phone and provide self-reports on their drinking habits, as well as other psychological and functional outcomes.

What is being tested?

The study tests if Acceptance and Commitment Therapy (ACT) can reduce alcohol use and improve mental health among people with HIV compared to a Brief Alcohol Intervention (BI). It's a randomized trial where participants are assigned by chance to one of these two treatments.

What are the potential side effects?

Since ACT involves psychological therapy without medication, side effects may include emotional discomfort or distress due to discussing personal issues. The BI typically does not involve significant side effects but could also cause similar emotional responses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 or older and receiving HIV treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, 8 weeks post-baseline, 3-, 6- , 12-months post-baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Alcohol Use - Quantity

Alcohol use - Frequency

Phosphatidylethanol (PEth)

Secondary study objectives

Biological levels of Stress

Self-reported levels of Stress

Symptoms of Anxiety

+2 more

Other study objectives

Adherence to HIV Medications

Alcohol-related Problems

Functional Impairment

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: Acceptance and Commitment Therapy (ACT)Experimental Treatment1 Intervention

Participants randomized to the ACT arm will receive six, weekly, 30-45-minute ACT intervention sessions delivered via telephone.

Group II: Brief Alcohol Intervention (BI)Active Control1 Intervention

Participants randomized to BI will receive two 30-60 minute sessions of a brief alcohol intervention delivered via telephone, two 5-10-minute booster calls, and two 5-minute reminder phone calls.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Commitment Therapy (ACT)

2016

Completed Phase 3

~1470

0 / 1Eligibility criteria met