Clinical trial NCT02576899: Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Official title: Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco
Posttraumatic Stress Disorder
Keywords: smoking cessation
posttraumatic stress disorder
tobacco
treatment
smoking
mindfulness
acceptance
functioning
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

This project involves a 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 \[FFS\] with all participants. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Current unstable DSM-5 bipolar disorder \[i.e., instability characterized by two or more manic or depressive episodes in the past 12 months, and a current Young Mania Rating Scale total score of 13 or a current Beck Depression Inventory (BDI) score of 19\]
* 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

Primary outcomes:
measure: 7-day Point Prevalence of Smoking Abstinence
timeFrame: Change in smoking abstinence from Baseline to End of Treatment (12 week outcome)
measure: PTSD Symptoms as Measured by the PTSD Checklist (PCL-5)
timeFrame: Change in PTSD symptoms from Baseline to End of Treatment (12 week outcome)
measure: Functional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)
timeFrame: Change in Functional Impairment from Baseline to End of Treatment (12 week outcome)
measure: Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire
timeFrame: Change in Quality of Life from Baseline to from Baseline to End of Treatment (12 week outcome)
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Megan M Kelly, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: