| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Apnea Syndromes Insomnia Disorder Stress Disorders, Post-Traumatic | Behavioral: Apnea and Insomnia Relief (AIR) Behavioral: Sleep Education (SE) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | The clinical interviewer conducting outcome-related interviews will be masked. |
| Primary Purpose: | Treatment |
| Official Title: | Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder |
| Actual Study Start Date : | February 27, 2020 |
| Estimated Primary Completion Date : | March 31, 2024 |
| Estimated Study Completion Date : | June 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
Behavioral: 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.
|
|
Active Comparator: 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.
|
Behavioral: 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.
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, California | |
| San Francisco VA Medical Center, San Francisco, CA | |
| San Francisco, California, United States, 94121 | |
| Principal Investigator: | Lizabeth A Goldstein, PhD | San Francisco VA Medical Center, San Francisco, CA |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||
| Last Update Posted Date | January 28, 2021 | ||||||
| Actual Study Start Date ICMJE | February 27, 2020 | ||||||
| Estimated Primary Completion Date | March 31, 2024 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Apnea and Insomnia Relief Study | ||||||
| Official Title ICMJE | Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder | ||||||
| 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study Masking: Single (Outcomes Assessor)Masking Description: The clinical interviewer conducting outcome-related interviews will be masked. Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||
| Estimated Enrollment ICMJE |
80 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | June 30, 2024 | ||||||
| Estimated Primary Completion Date | March 31, 2024 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04007796 | ||||||
| Other Study ID Numbers ICMJE | D2952-W | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||
| Verification Date | January 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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