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

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Behavioral Sleep Education Intervention — BEHAVIORAL
    Manual-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 Intervention
    Manual-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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare SystemNorth HillsCalifornia91343
Monica Kelly, PhD
818-891-7711
Monica Kelly, PhD (PRINCIPAL_INVESTIGATOR)

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