Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
Part of paid clinical trials in North Hills, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT05516277
- Status
- Recruiting
Conditions
- Cardiovascular Diseases
- Insomnia
- Metabolic Disease
- Posttraumatic Stress Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Behavioral Sleep Education Intervention — BEHAVIORALManual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.
Study Details
This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study 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. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
Key Dates
- Start date
- Apr 1, 2023
- Status verified
- Apr 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 167 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Behavioral Sleep Education InterventionManual-based education program focusing on behavioral sleep techniques provided in individual 60-minute sessions for 5 weekly sessions.
Primary Outcome Measure
Consensus sleep diary questionnaire [ Time Frame: Change from baseline to 1 week after completion of sleep intervention ]
Central Contacts
- Monica Kelly, PhD818-891-7711
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System | North Hills | California | 91343 | Monica Kelly, PhD (PRINCIPAL_INVESTIGATOR) |
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