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

Cardiovascular Diseases Clinical Trial

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

Status Recruiting

Clinical Trial Summary

This pilot randomized controlled 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 one of two non-medication sleep education and treatment programs 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.

Clinical Trial Description

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 randomized controlled trial provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by one of two non-medication sleep education and treatment programs 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 be randomly assigned to receive one of two sleep education programs (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 clinical trials.

The investigators hope to determine which sleep education program is most effective in improving sleep quality and how these programs affect health. 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. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Insomnia
• Metabolic Disease
• Metabolic Diseases
• Posttraumatic Stress Disorder
• Sleep Initiation and Maintenance Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT05516277
• Study type: Interventional
• Source: University of California, Los Angeles
• Contact: Monica Kelly, PhD
• Phone: 818-891-7711
• Email: monica.kelly2@va.gov
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Completion date: March 31, 2027