Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
Overview
- Phase
- Phase 2
- Intervention
- Apnea and Insomnia Relief (AIR)
- Conditions
- Sleep Apnea Syndromes
- Sponsor
- VA Office of Research and Development
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- World Health Organization Quality of Life (WHOQOL-BREF)
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
Detailed Description
This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study and recommended for PAP therapy
- •Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
- •Meet DSM-5 Criteria for Insomnia Disorder
- •Willing to attend all treatment and assessment appointments
- •English literacy and cognition sufficient to participate in treatment and assessment
Exclusion Criteria
- •Psychosis or manic episode in last 5 years
- •Moderate or severe substance use disorder in past 6 months
- •Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial
- •Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial
- •Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
- •Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator)
- •Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator)
- •Working night shifts or rotating shifts that include night shifts
- •Lack of stable housing
- •Pregnancy
Arms & Interventions
Apnea and Insomnia Relief (AIR)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Intervention: Apnea and Insomnia Relief (AIR)
Sleep Education (SE)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Intervention: Sleep Education (SE)
Outcomes
Primary Outcomes
World Health Organization Quality of Life (WHOQOL-BREF)
Time Frame: Change from baseline to 3 months after treatment ends
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
World Health Organization Quality of Life (WHOQOL-BREF)
Time Frame: Change from baseline to 1 week post-treatment (after 6 weeks)
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
Secondary Outcomes
- Functional Outcomes of Sleep Questionnaire (FOSQ-10)(Change from baseline to 3 months after treatment ends)
- Insomnia Severity Index (ISI)(Change from baseline to 3 months after treatment ends)
- CPAP Adherence(Past 7 days, at 3 months after treatment ends)
- Clinician Administered PTSD Scale for DSM-5 (CAPS-5)(Change from baseline to 1 week post-treatment (after 6 weeks))
- Total Sleep Time (Actigraphy-based)(Change from baseline to 1 week post-treatment (after 6 weeks))
- Functional Outcomes of Sleep Questionnaire (FOSQ-10)(Change from baseline to 1 week post-treatment (after 6 weeks))
- Insomnia Severity Index (ISI)(Change from baseline to 1 week post-treatment (after 6 weeks))
- CPAP Adherence(Past 7 days, at 1 week after treatment ends)