Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder

Both insomnia and Post Traumatic Stress Disorder (PTSD) are independent risk factors for cardiometabolic diseases; the leading causes of morbidity and mortality in the US for which the growing geriatric population is at elevated risk. PTSD and insomnia disorder frequently co-occur yet require unique treatments, as sleep difficulties are one of the most common residual symptoms that remain after completing an evidence-based PTSD treatment.

This pilot pre-post trial provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. Individuals over 50 years of age, who have received care at the VA Greater Los Angeles Healthcare System, and who have been exposed to a stressful or traumatic life event will be recruited for this study.

Participants will be asked to complete a baseline evaluation that involves (a) being asked questions about health, medications, personal information, quality of life, sleep patterns and habits, mood, and stressful/traumatic experiences; (b) wearing a blood pressure monitor at home for 24 hours; (c) wearing a continuous glucose monitor sensor that contains a small filament (a thread-sized needle) inserted into the upper arm or abdomen for 7 consecutive days; (d) wearing a wristwatch device that measures sleep/wake patterns for 7 consecutive days; and (e) completing a daily sleep diary for 7 consecutive days. Participants may also be screened for sleep apnea with a portable sleep apnea monitoring device with sensors worn on the wrist, index finger and chest for one night.

Information from the baseline evaluation and medical records will be reviewed by the research team to determine whether an individual is eligible and likely able to complete all future study activities. Participants will be contacted to be advised of their study eligibility status. If eligible after the baseline assessment, study staff will review future study activities and confirm the participant's interest in continuing in the study. All eligible and interested participants will then receive an evidence-based PTSD treatment (CPT; 12 sessions). Following completion of the PTSD treatment, participants will receive a sleep education program (CBT-I; 5 sessions). For eligible individuals, participation in this research will last about 11 months.

Main study outcomes assessments from the baseline evaluation will be repeated three times: (1) one week after completion of the PTSD treatment; (2) one week after completion of the sleep education program; and (3) 6-months after the sleep education program ends. Data will be analyzed using "intention to treat" principles, using appropriate statistical methods for pilot clinical trials.

The investigators hope to determine how these treatment programs affect health in older adults with PTSD and insomnia. Findings from this pilot study will expand our understanding of the relationships between evidence-based insomnia and trauma treatments and key outcomes of sleep, PTSD symptoms, cardiometabolic health and quality of life in older adults with PTSD and insomnia while informing future research.

• Homeostatic Model Assessment of Insulin Resistance (HOMA) [Time frame: Change from baseline to 1 week after completion of sleep intervention]
• Hemoglobin A1c (HbA1c) [Time frame: Change from baseline to 6 months after completion of sleep intervention]
• Body Mass Index (BMI) [Time frame: Change from baseline to 1 week after completion of sleep intervention]
• Central adiposity [Time frame: Change from baseline to 1 week after completion of sleep intervention]
• Actigraphy [Time frame: Change from baseline to 1 week after completion of sleep intervention]
• Dyslipidemia [Time frame: Change from baseline to 1 week after completion of sleep intervention]