Improving Functional Outcomes of Veterans With PTSD and Tobacco Dependence

NCT02576899 | Completed Phase 1 Results

• 2 other identifiers: D1756-P121RX-001756-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco; Posttraumatic Stress Disorder

Keywords

smoking cessation; posttraumatic stress disorder; tobacco; treatment; smoking; mindfulness; acceptance; functioning

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Stage 1b Study of ACT-PT vs. FFS

ACTIVE COMPARATOR

This study 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 \[FFS\]. 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.

Behavioral: Acceptance and Commitment Therapy for PTSD and Tobacco Use

Freedom From Smoking

PLACEBO COMPARATOR

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

Behavioral: Freedom From Smoking

Interventions

Acceptance and Commitment Therapy for PTSD and Tobacco Use BEHAVIORAL

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.

Stage 1b Study of ACT-PT vs. FFS

Freedom From Smoking BEHAVIORAL

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

Freedom From Smoking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Megan M. Kelly, Ph.D.
• Organization: VISN 1 MIRECC

Megan.Kelly1@va.gov

781-687-3317

Study Officials

• Megan M Kelly, PhD MS

  Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 15, 2015
• Study Start: September 1, 2015
• Primary Completion: March 30, 2019
• Study Completion: December 31, 2019
• Last Updated: April 10, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)