San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563, United States
NCT Number: NCT04007796
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
San Francisco, California, 94121-1563, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
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 3 months after treatment ends
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)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Time frame: Change from baseline to 3 months after treatment ends
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
An actigraph will be used to determine total sleep time. An actigraph is a validated objective sleep measurement device commonly used outside the laboratory setting to detect movement and infer sleep and wake based on wrist activity.
Time frame: Past 7 days, at 1 week after treatment ends
Average daily CPAP use.
Time frame: Past 7 days, at 3 months after treatment ends
Average daily CPAP use.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
This 30-item semi-structured interview provides a dimensional and categorical measure of PTSD. The severity score is based on frequency and intensity of PTSD symptoms. Categorically, it determines presence of both lifetime and current PTSD. Current and lifetime PTSD will be assessed at pre-treatment. Only current PTSD will be assessed at post-treatment. This interview also assesses the onset and duration of symptoms, distress, impact of symptoms on functioning (social and occupational), change in symptoms since a previous administration, response validity, and dissociative subtype of PTSD. Total score ranging from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
VA Office of Research and Development
Fed
Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
Acronym: AIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04399200
Apnea, Arterial Occlusive Diseases
Grenoble, France
View Trial DetailsNCT06283017
Apnea, Dyssomnias
Adelaide, South Australia, Australia
View Trial DetailsNCT06627127
Apnea, Dyssomnias
Wollongong, New South Wales, Australia
View Trial DetailsNCT06283030
Apnea, Dyssomnias
Nashville, Tennessee, United States
View Trial Details