NCT04007796 - Apnea and Insomnia Relief Study | Crick

Overview

The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

36

Conditions

Sleep Apnea Syndromes Insomnia Disorder Stress Disorders, Post-Traumatic

Interventions

Apnea and Insomnia Relief (AIR)BEHAVIORAL

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.

Sleep Education (SE)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Outcomes

Primary Outcomes

World Health Organization Quality of Life (WHOQOL-BREF)

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.

Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)

World Health Organization Quality of Life (WHOQOL-BREF)

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.

Time frame: Change from baseline to 3 months after treatment ends

Secondary Outcomes

Functional Outcomes of Sleep Questionnaire (FOSQ-10)

This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.

Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)

Functional Outcomes of Sleep Questionnaire (FOSQ-10)

This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.