CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Acceptance and Commitment Therapy for PTSD and Tobacco Use +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02576899
NCT02576899Phase 1Completed

Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

VA Office of Research and Development·interventional·Posted Oct 15, 2015·Updated Apr 10, 2020

In Brief

A Phase 1 clinical trial evaluating Acceptance and Commitment Therapy for PTSD and Tobacco Use and Freedom From Smoking for Tobacco and Posttraumatic Stress Disorder. Completed, enrolled 36 participants across 1 site.

Detailed 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, treatment adherence, fidelity, ease of the assessment process), and 2) evaluate the preliminary efficacy of ACT-PT vs. FFS with the primary outcomes of tobacco use, PTSD symptoms, health-related quality of life, and functional impairment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 15, 2015
Enrollment StartSep 1, 2015
Primary CompletionMar 30, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.7 years ago

Interventions

Acceptance and Commitment Therapy for PTSD and Tobacco Usebehavioral

ACT-PT 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.

Freedom From Smokingbehavioral

The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.