Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence



Status:Recruiting
Conditions:Smoking Cessation, Psychiatric, Psychiatric, Tobacco Consumers
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:September 1, 2015
End Date:March 30, 2019
Contact:Megan M Kelly, PhD MS
Email:megan.kelly1@va.gov
Phone:(857) 364-6196

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Veterans with PTSD have high rates of smoking (34%-86% vs. 18% in the general population) and
have substantial difficulties with quitting tobacco. Only 23% of individuals with PTSD quit
smoking compared to 50% of the general population. As a result, Veterans with PTSD are at
high risk of developing severe health problems and poor physical functioning. Fifty percent
of these long-term smokers will die of a smoking-related cause and on average, will lose 25
years of their life compared to non-smokers. 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 emphasis on substantially improving health-related quality of life and
functioning across several areas makes ACT-PT particularly innovative and different from
existing treatments. However, research is needed on the relative feasibility, acceptability,
and efficacy of ACT-PT compared to standard smoking cessation treatments.

The proposed SPiRE (I21) will involve a randomized clinical trial study of 50 Veteran smokers
with PTSD and tobacco dependence randomized to one of two different types of psychosocial
treatment 10 individual sessions of ACT-PT (n= 25) versus 10 individual sessions of the
American Lung Association's Freedom From Smoking Program [FFS] (n=25) with all participants
receiving 12 weeks of the nicotine patch. 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.


Inclusion Criteria:

- Veterans enrolled at the Edith Nourse Rogers Memorial Veterans Hospital

- Current DSM-5 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

Exclusion Criteria:

- 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 13 or a current BDI score 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
We found this trial at
1
site
Bedford, Massachusetts 01730
Principal Investigator: Megan Marie Kelly, PhD MS
Phone: (857) 364-6196
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from
Bedford, MA
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