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NCT03974061 · ClinicalTrials.gov registry record · NA
Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers
A NA study of Treatment, sponsored by Syracuse University.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT03974061: Completed NA study of Treatment, sponsored by Syracuse University.
NCT03974061 is a NA study of Treatment that has completed, run by Syracuse University. The registered enrollment target is 49 participants, below the 173-participant average among 5 other Treatment trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03974061, a NA study of Treatment, has completed, sponsored by Syracuse University.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
Alcohol consumption at hazardous levels is associated with negative consequences on nearly every step of the HIV care continuum. It is a critical factor in HIV treatment that, if unaddressed, significantly contributes to onward transmission and poor treatment outcomes. Alcohol interventions for people living with HIV (PLWH) in the United States (US) have shown mixed results, and no alcohol intervention for PLHW has shown long-term reductions in heavy drinking or a significant impact on HIV-related outcomes. One hypothesized reason for this limited success is the failure of these interventions to address the multiple overlapping problems (e.g., comorbid mental health conditions, behavioral health needs) of PLWH who are hazardous drinkers. Innovative alcohol intervention strategies that can have an impact on these multiple behavioral health needs, in a format that can be feasibly delivered in the context of HIV care, are needed. Brief Acceptance and Commitment Therapy (ACT) is a promising intervention for HIV-infected hazardous drinkers. ACT is a transdiagnostic treatment that uses mindfulness skills and values-guided behavioral action plans to impact a broad array of psychological symptoms. ACT has shown efficacy for treatment of anxiety, depression, chronic pain, and substance use, making it a promising approach for hazardous drinkers. The overall objective of this application is to adapt an existing brief ACT intervention developed for smoking cessation, and pilot test its feasibility and acceptability for PLWH who are hazardous drinkers. We hypothesize that the resulting intervention will be preliminarily associated with decreased alcohol use, improved ART adherence, decreased symptoms of depression, anxiety, and drug use, and increased acceptance-a known mechanism of change in ACT.
Primary Outcome
Alcohol consumption was measured by retrospective self-report via the Time Line Follow Back (TLFB) interview method which yields number of drinking days over the last 42-day period.
Conditions Studied
Interventions
- BEHAVIORAL Brief Alcohol Intervention
- BEHAVIORAL Brief Acceptance and Commitment Therapy
Study Locations (1)
New York
- Syracuse University - Syracuse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2022-11-10 |
| Phase | NA |
What the finished NCT03974061 record still lists
NCT03974061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 173-participant average among 5 other Treatment trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Treatment appearing as the primary indexed condition, and to 2 interventions - of which Brief Alcohol Intervention is the first listed.
NCT03974061 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03974061 about?
NCT03974061 is a clinical study titled "Brief Acceptance and Commitment Therapy for HIV-infected At-risk Drinkers". Alcohol consumption at hazardous levels is associated with negative consequences on nearly every step of the HIV care continuum. It is a critical factor in HIV treatment that, if unaddressed, significantly contributes to onward transmission and poor treatment outcomes. Alcohol interventions for peop...
What is the current status of trial NCT03974061?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2019-11-01. Estimated completion is 2022-11-10.
What conditions does trial NCT03974061 study?
This clinical trial studies the following conditions: Treatment.
What interventions are being tested in trial NCT03974061?
The interventions under investigation include: Brief Alcohol Intervention (BEHAVIORAL), Brief Acceptance and Commitment Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03974061?
This trial is sponsored by Syracuse University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03974061 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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