BACKGROUND/RATIONALE:
Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk. Although SDB is more common among men than women, it still impacts 17% of women in the general population. [The investigators' preliminary evidence suggests it is even more common among women Veterans who receive VA care.] The recommended first-line therapy for most patients with SDB is positive airway pressure therapy (PAP). Published studies show that women have lower PAP adherence than men, particularly in the US, yet the investigators are not aware of data comparing men and women Veterans. Because women Veterans experience significant sleep disturbance and other consequences of sleep disorders, adjusting to PAP therapy may be quite difficult. To date, studies have not tested interventions specifically designed to improve PAP adherence among women, accounting for important sleep-related and social factors.

OBJECTIVE(S):
Aim 1: Test the efficacy of the ABC-SA program in improving PAP adherence, compared to a control program modeled after usual care, for women Veterans with SDB.

Aim 2: Test the efficacy of the ABC-SA program for improving objectively-measured and patient reported sleep quality, compared to the control program.

Exploratory Aim 3: Test the efficacy of the ABC-SA program for improving quality of life and symptoms of depression, compared to the control program.

METHODS:
This study is a randomized controlled trial (RCT) to test the efficacy of a program combining patient education with behavioral techniques to improve adherence to PAP therapy. Women Veterans 18 years and older, who have received care at the VA Greater Los Angeles Healthcare System, and who have at least 1 risk factor for sleep disordered breathing (SDB) will be recruited for this study. Screening for sleep apnea will be performed in the participant's home using a WatchPAT device. Both objective (actigraphy) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an AHI of 5 or higher, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.

Participants will be randomized to two groups. PAP devices, along with education about SDB and insomnia, will be provided to participants in both groups as part of the 6-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months.

Main study outcomes (sleep quality and PAP adherence) will be assessed 3 months after PAP initiation, and PAP adherence will be tracked remotely for 12 months. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for clinical trials.

FINDINGS/RESULTS:
This is a new study and there are no findings to report.

IMPACT:
The long-term objective of this program of research is to advance VA toward efficient and optimal implementation of best practices for treatment of all sleep disorders among women Veterans. We see the proposed work as a critical step in that process.

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External Links for this Project

NIH Reporter

Grant Number: I01HX002300-01A1
Link: https://reporter.nih.gov/project-details/9394752

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PUBLICATIONS:

Journal Articles

1. Ravyts SG, Erickson AJ, Washington DL, Yano EM, Carlson GC, Mitchell MN, Kelly M, Alessi CA, McGowan SK, Song Y, Martin JL, Dzierzewski JM. A non-inferiority randomized controlled trial comparing behavioral sleep interventions in women veterans: An examination of pain outcomes. Journal of psychosomatic research. 2023 Oct 21; 175:111536. [view]
2. Saldaña KS, McGowan SK, Martin JL. Acceptance and Commitment Therapy as an Adjunct or Alternative Treatment to Cognitive Behavioral Therapy for Insomnia. Sleep medicine clinics. 2023 Mar 1; 18(1):73-83. [view]
3. Carlson GC, Kelly MR, Mitchell M, Josephson KR, McGowan SK, Culver NC, Kay M, Alessi CA, Fung CH, Washington DL, Hamilton A, Yano EM, Martin JL. Benefits of Cognitive Behavioral Therapy for Insomnia for Women Veterans with and without Probable Post-Traumatic Stress Disorder. Women's health issues : official publication of the Jacobs Institute of Women's Health. 2022 Mar 1; 32(2):194-202. [view]
4. Moghtaderi I, Kelly MR, Carlson GC, Fung CH, Josephson KR, Song Y, Swistun D, Zhu R, Mitchell M, Lee D, Badr MS, Washington DL, Yano EM, Alessi CA, Zeidler MR, Martin JL. Identifying gaps in clinical evaluation and treatment of sleep-disordered breathing in women veterans. Sleep & Breathing = Schlaf & Atmung. 2023 Oct 1; 27(5):1929-1933. [view]
5. Carlson GC, Kelly MR, Grinberg AM, Mitchell M, McGowan SK, Culver NC, Kay M, Alessi CA, Washington DL, Yano EM, Martin JL. Insomnia Precipitating Events among Women Veterans: The Impact of Traumatic and Nontraumatic Events on Sleep and Mental Health Symptoms. Behavioral sleep medicine. 2021 Sep 1; 19(5):672-688. [view]

DRA: Aging, Older Veterans' Health and Care, Health Systems Science
DRE: Treatment - Implementation, TRL - Applied/Translational, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: none
MeSH Terms: none