Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

Completed · Phase 1

Conditions studied: Tobacco, Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID: NCT02576899
Run by: VA Office of Research and Development
People needed: 36
Starts: 2015-09-01
Expected to finish: 2019-12-31
Last updated by the study team: 2020-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Veterans enrolled at the Edith Nourse Rogers Memorial Veterans Hospital
Current Diagnostic and Statistical Manual (DSM-5) Diagnosis of PTSD
Minimum score of 38 (clinical cutoff for PTSD) on the PTSD Checklist for DSM-5
A regular smoker for at least 3 years
Currently smoking at least 10 cigarettes per day
Able to communicate meaningfully with the investigator
Competent to provide written informed consent
Ages 18 and older

You may not qualify if…

Current unstable DSM-5 bipolar disorder [i.e., instability characterized by two or more manic or depressive episodes in the past 12 months, and a current Young Mania Rating Scale total score of 13 or a current Beck Depression Inventory (BDI) score of 19]
Any lifetime DSM-5 psychotic disorder
Current or recent (within 1 month of study entry) moderate or severe DSM-5 alcohol or drug use disorder
Use of other tobacco products
A cognitive impairment that would interfere with participation
A suicide attempt or severe suicidal ideation within the past 3 months
Presence of any clinical features requiring inpatient or partial hospital treatment
Use of any other tobacco cessation counseling

Where it is running

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA — Bedford, Massachusetts, United States

Full record on ClinicalTrials.gov

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