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NCT05016960 · ClinicalTrials.gov registry record · NA
SleepSMART for Veterans With MCI and Insomnia
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT05016960: Completed NA study, sponsored by VA Office of Research and Development.
NCT05016960 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05016960, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.
Primary Outcome
Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.
Interventions
- BEHAVIORAL Sleep-SMART
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT05016960 record still lists
NCT05016960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Sleep-SMART is the first listed.
NCT05016960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05016960 about?
NCT05016960 is a clinical study titled "SleepSMART for Veterans With MCI and Insomnia". Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Reh...
What is the current status of trial NCT05016960?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2022-01-04. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT05016960?
The interventions under investigation include: Sleep-SMART (BEHAVIORAL).
Who is sponsoring clinical trial NCT05016960?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05016960's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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