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NCT05516277 · ClinicalTrials.gov registry record · NA
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
A NA study of Cardiovascular Diseases and Post Traumatic Stress Disorder, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- NA
- Development phase
- 167
- Enrollment target
- 1
- Study location
NCT05516277: Recruiting NA study of Cardiovascular Diseases and Post Traumatic Stress Disorder, sponsored by University of California, Los Angeles.
NCT05516277 is a NA study of Cardiovascular Diseases and Post Traumatic Stress Disorder that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 167 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05516277, a NA study of Cardiovascular Diseases and Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- NA
- Development phase
- 167 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Self-reported sleep quality assessed with the Consensus sleep diary, a brief patient questionnaire evaluating multiple aspects of sleep quality including sleep onset latency (time to fall asleep in minutes) and sleep efficiency percentage (time asleep in minutes/time in bed in minutes x 100).
Conditions Studied
Interventions
- BEHAVIORAL Behavioral Sleep Education Intervention
Study Locations (1)
California
- VA Greater Los Angeles Healthcare System - North Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT05516277 shows while recruiting
NCT05516277 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Behavioral Sleep Education Intervention is the first listed.
NCT05516277 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05516277 about?
NCT05516277 is a clinical study titled "Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder". 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....
What is the current status of trial NCT05516277?
This trial is currently recruiting. It is a NA study. The enrollment target is 167 participants. The study started on 2023-04-01. Estimated completion is 2027-03-31.
What conditions does trial NCT05516277 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Post Traumatic Stress Disorder, Insomnia, Metabolic Disease.
What interventions are being tested in trial NCT05516277?
The interventions under investigation include: Behavioral Sleep Education Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05516277?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05516277 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05516277's enrollment target sits among peer trials
167 164th of 300 higher than 135 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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