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NCT03904186 · ClinicalTrials.gov registry record · NA
Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
NCT03904186: Completed NA study, sponsored by Massachusetts General Hospital.
NCT03904186 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 131 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904186, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
Study Summary
Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which often exacerbates anxiety/depression. In a previous project, the feasibility, acceptability, and initial efficacy of a 9-session, cognitive-behavioral-based intervention to address smoking cessation by reducing anxiety and depression via specific emotional vulnerabilities (anxiety sensitivity, distress tolerance, and anhedonia) was tested against an enhanced standard of care in a pilot randomized controlled trial (NCT01393301). It was found that when compared to a brief enhanced treatment as usual control, patients in the intervention achieved higher short-term and long-term smoking abstinence rates. In this project, the investigators seek to test this same intervention in a fully powered, 3-arm efficacy/effectiveness trial. The goal of this study is to randomize 180 smokers across three sites to test the efficacy/effectiveness of the intervention at increasing point prevalence abstinence by reducing anxiety and depression at a 1-month follow-up (the end of treatment timepoint/ approximately 1-month post quit day) and a 6-month follow-up (approximately 6-months post quit day).
Interventions
- BEHAVIORAL QUIT
- BEHAVIORAL Time-Matched Control (TM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03904186
The ClinicalTrials.gov registry entry for NCT03904186 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which QUIT is the first listed.
NCT03904186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03904186 about?
NCT03904186 is a clinical study titled "Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV". Smokers living with HIV represent a major health disparity population in the United States and the world more generally. Major contributing factors to the maintenance and relapse of smoking among smokers living with HIV include increased exposure to multiple stressors associated with HIV, which ofte...
What is the current status of trial NCT03904186?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2019-12-19. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT03904186?
The interventions under investigation include: QUIT (BEHAVIORAL), Time-Matched Control (TM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03904186?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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