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NCT02576899 · ClinicalTrials.gov registry record · Phase 1
Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
A Phase 1 study of Posttraumatic Stress Disorder and Tobacco, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02576899 is a Phase 1 study of Posttraumatic Stress Disorder and Tobacco that has completed, run by VA Office of Research and Development. The registered enrollment target is 36 participants, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02576899, a Phase 1 study of Posttraumatic Stress Disorder and Tobacco, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as an obstacle to quit smoking, although this is a significant barrier to quitting for many Veterans. In addition, no smoking cessation treatments have a large emphasis on improving the functioning of Veterans with PTSD and tobacco dependence, although both PTSD and tobacco use negatively affect functioning across physical, mental health, and social domains. The goal of this SPiRE project is to evaluate Acceptance and Commitment Therapy for Veterans with PTSD and Tobacco Use (ACT-PT), which is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values. This project involves a small randomized clinical trial study of Veteran smokers with PTSD and tobacco dependence randomized to one of two different types of psychosocial treatment: ACT-PT versus the American Lung Association's Freedom From Smoking Program \[FFS\]. This study has two primary aims: 1) evaluate the relative feasibility and acceptability of the two interventions (including ease of recruitment, randomization proportion, staff and Veteran acceptance of the treatment, retention rates, treatmen
Conditions Studied
Interventions
- BEHAVIORAL Acceptance and Commitment Therapy for PTSD and Tobacco Use
- BEHAVIORAL Freedom From Smoking
Study Locations (1)
Massachusetts
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA - Bedford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-09-01 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02576899
The ClinicalTrials.gov registry entry for NCT02576899 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (68% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Acceptance and Commitment Therapy for PTSD and Tobacco Use is the first listed.
NCT02576899 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02576899 about?
NCT02576899 is a clinical study titled "Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence". Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and have substantial difficulties with quitting tobacco. Despite the significant morbidity and mortality associated with smoking, no smoking cessation treatments exist that intensively target PTSD symptoms as a...
What is the current status of trial NCT02576899?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-09-01. Estimated completion is 2019-12-31.
What conditions does trial NCT02576899 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder, Tobacco.
What interventions are being tested in trial NCT02576899?
The interventions under investigation include: Acceptance and Commitment Therapy for PTSD and Tobacco Use (BEHAVIORAL), Freedom From Smoking (BEHAVIORAL).
Who is sponsoring clinical trial NCT02576899?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02576899 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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