Insomnia Disorder, Sleep Apnea Syndromes, Stress Disorders, Post-Traumatic
Conditions
Keywords
Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Disorder, Stress Disorders, Post-Traumatic, PTSD, Veterans
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.
Interventions
BEHAVIORALApnea 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.
BEHAVIORALSleep 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinical interviewer conducting outcome-related interviews will be masked.
Intervention model description
Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Quality of Life (WHOQOL-BREF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes of Sleep Questionnaire (FOSQ-10) | 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. |
| Insomnia Severity Index (ISI) | 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. |
| Total Sleep Time (Actigraphy-based) | 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. |
| CPAP Adherence | Past 7 days, at 1 week after treatment ends | Average daily CPAP use. |
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLizabeth A Goldstein, PhD
San Francisco VA Medical Center, San Francisco, CA
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Apnea and Insomnia Relief (AIR) | Sleep Education (SE) | Total |
|---|---|---|---|
| Age, Continuous | 51.06 years STANDARD_DEVIATION 12.19 | 49.44 years STANDARD_DEVIATION 12.16 | 50.29 years STANDARD_DEVIATION 12.02 |
| Race/Ethnicity, Customized Race/ethnicity Asian | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity Caucasian/White | 11 Participants | 8 Participants | 19 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
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.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apnea and Insomnia Relief (AIR) | World Health Organization Quality of Life (WHOQOL-BREF) | Baseline | 11.26 units on a scale | Standard Deviation 1.91 |
| Apnea and Insomnia Relief (AIR) | World Health Organization Quality of Life (WHOQOL-BREF) | Post-Treatment | 12.78 units on a scale | Standard Deviation 2.04 |
| Sleep Education (SE) | World Health Organization Quality of Life (WHOQOL-BREF) | Baseline | 9.75 units on a scale | Standard Deviation 2.95 |
| Sleep Education (SE) | World Health Organization Quality of Life (WHOQOL-BREF) | Post-Treatment | 10.84 units on a scale | Standard Deviation 2.8 |
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.
Time frame: Change from baseline to 3 months after treatment ends
Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apnea and Insomnia Relief (AIR) | World Health Organization Quality of Life (WHOQOL-BREF) | Baseline | 11.26 units on a scale | Standard Deviation 1.91 |
| Apnea and Insomnia Relief (AIR) | World Health Organization Quality of Life (WHOQOL-BREF) | 3-Month Follow-Up | 12.47 units on a scale | Standard Deviation 2.55 |
| Sleep Education (SE) | World Health Organization Quality of Life (WHOQOL-BREF) | Baseline | 9.75 units on a scale | Standard Deviation 2.95 |
| Sleep Education (SE) | World Health Organization Quality of Life (WHOQOL-BREF) | 3-Month Follow-Up | 10.71 units on a scale | Standard Deviation 2.39 |
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.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)
Secondary
CPAP Adherence
Average daily CPAP use.
Time frame: Past 7 days, at 1 week after treatment ends
Secondary
CPAP Adherence
Average daily CPAP use.
Time frame: Past 7 days, at 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks)