Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

Posttraumatic Stress Disorder Clinical Trial

— ACT-PT  

Official title:

Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576899
• Other study ID #: D1756-P
• Secondary ID: 121RX-001756-01A
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tobacco
• Tobacco Use Disorder

Intervention

Behavioral:
• Acceptance and Commitment Therapy for PTSD and Tobacco Use
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 Smoking
The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Point Prevalence of Smoking Abstinence	Smoking outcomes will include a self-report of the number of cigarettes smoked at end of treatment, 1-month follow-up, and the 3-month follow-up, verified by carbon monoxide (CO) breath tests (< 8 ppm).	Change in smoking abstinence from Baseline to End of Treatment (12 week outcome)
Primary	PTSD Symptoms as Measured by the PTSD Checklist (PCL-5)	The PCL-5 is a brief, self-report symptom checklist that assesses the 20 symptoms of PTSD outlined in the Diagnostic and Statistical Manual-5 (DSM-5) and was designed to assess symptom changes during and after treatment in addition to screening. The PCL has shown satisfactory temporal stability, internal consistency, test-retest reliability, and convergent validity. The minimum value of the PCL-5 is 0, and the maximum value is 80. Higher scores indicate more severe PTSD symptoms.	Change in PTSD symptoms from Baseline to End of Treatment (12 week outcome)
Primary	Functional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)	The Short Form 36 Health Survey (SF-36) is a 36-item self-report measure of current physical, mental health, and social functioning. We are reporting the mental health functioning outcome. A total score was computed by summing and transforming the five-item scores into a score between 0 (lowest mental health) and 100 (highest mental health). Lower scores indicate more severe functioning related to mental health problems.	Change in Functional Impairment from Baseline to End of Treatment (12 week outcome)
Primary	Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire	The Quality of Life Enjoyment and Satisfaction Questionnaire is a commonly used self-report measure to assess quality of life in several domains: general activities, physical health, subjective feelings, leisure time activities, social relationships, work, and household duties. Higher scores indicate better enjoyment and satisfaction with life. The scoring of the Quality of Life Enjoyment and Satisfaction Questionnaire involves summing the first 14 items to yield a total score. The total score ranges from 14 to 70 and is expressed as a percentage based on the maximum total score of the items completed (0-100).	Change in Quality of Life from Baseline to from Baseline to End of Treatment (12 week outcome)