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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apnea and Insomnia Relief (AIR) | Experimental | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change from baseline to 3 months after treatment ends |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 1 week post-treatment (after 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizabeth A Goldstein, PhD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121-1563 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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36 Veterans were randomized to treatment. 34 Veterans' data were retained for data analysis. Two Veterans' data were excluded because exclusion criteria were met during the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 1 week post-treatment (after 6 weeks) |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Liz Goldstein | San Francisco VA Health Care System | 415-694-3443 | lizabeth.goldstein2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2025 | Oct 22, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2020 | Oct 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D020182 | Sleep Apnea, Central |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
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The clinical interviewer conducting outcome-related interviews will be masked.
|
| 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. |
|
| 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. | Change from baseline to 3 months after treatment ends |
| Insomnia Severity Index (ISI) | 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. | Change from baseline to 1 week post-treatment (after 6 weeks) |
| Insomnia Severity Index (ISI) | 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. | Change from baseline to 3 months after treatment ends |
| Total Sleep Time (Actigraphy-based) | 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. | Change from baseline to 1 week post-treatment (after 6 weeks) |
| CPAP Adherence | Average daily CPAP use. | Past 7 days, at 1 week after treatment ends |
| CPAP Adherence | Average daily CPAP use. | Past 7 days, at 3 months after treatment ends |
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 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. | Change from baseline to 1 week post-treatment (after 6 weeks) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One participant did not specify their race/ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3 months after treatment ends |
|
|
|
| Secondary | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 1 week post-treatment (after 6 weeks) |
|
|
|
| Secondary | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3 months after treatment ends |
|
|
|
| Secondary | Insomnia Severity Index (ISI) | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 1 week post-treatment (after 6 weeks) |
|
|
|
| Secondary | Insomnia Severity Index (ISI) | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3 months after treatment ends |
|
|
|
| Secondary | Total Sleep Time (Actigraphy-based) | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | minutes | Change from baseline to 1 week post-treatment (after 6 weeks) |
|
|
|
| Secondary | CPAP Adherence | Average daily CPAP use. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | minutes | Past 7 days, at 1 week after treatment ends |
|
|
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| Secondary | CPAP Adherence | Average daily CPAP use. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | minutes | Past 7 days, at 3 months after treatment ends |
|
|
|
| Secondary | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 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. | An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 1 week post-treatment (after 6 weeks) |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| Asian |
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| Hispanic or Latino |
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| Other |
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| 3-Month Follow-Up |
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| Post-Treatment |
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| 3-Month Follow-Up |
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| Post-Treatment |
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| 3-Month Follow-Up |
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| Post-Treatment |
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| Post-Treatment |
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