Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2020-02-27
2025-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Lizabeth A Goldstein, PhD
Role: PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Locations
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San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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D2952-W
Identifier Type: -
Identifier Source: org_study_id
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