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NCT03727438 · ClinicalTrials.gov registry record · NA
Tele-Self CBTI Trial
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 178
- Enrollment target
NCT03727438: Completed NA study, sponsored by VA Office of Research and Development.
NCT03727438 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 178 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03727438, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 178 participants
- Enrollment target
Study Summary
Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia has been shown to play a causal role in mental health, hypertension, obesity, and other health conditions, increasing risk for all-cause mortality. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than medications, but access to behavioral sleep medicine expertise within the VA is very limited. This study compares Tele-Self CBTI to Health Education Control for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this study, 200 participants will be randomized with a 50/50 chance to either Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; and/or c) referred for clinic-based CBTI (but not yet treated) for insomnia. Participants will be identified using electronic health records (EHR) and telephone interviews. Participants' sleep will be assessed at three time points, at Baseline, 8 weeks and 6 months after Baseline. The Tele-Self CBTi intervention is comprised of two treatment components: 1) self-directed treatment via weekly readings from a treatment manual, and 2) weekly telephone-based nurse support contacts across a 8 week intervention period. Participants randomized to Tele-Self CBTI will complete 6 weekly readings in addition to having 6 weekly telephone contacts with a study nurse; each call lasting approximately 20 minutes. Patients randomized to Health Education Control (HEC) will receive a health education manual on 6 health topics. They will also complete 6 weekly readings from the HEC manual and receive 6 weekly telephone contacts from a study nurse. All participants will continue to receive usual medical care while participating in the study. Following completion of this 6 month study, participants randomized
Interventions
- BEHAVIORAL Tele-Self CBTI
- OTHER Health Education Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2019-10-04 |
| Est. Completion | 2023-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03727438
The ClinicalTrials.gov registry entry for NCT03727438 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tele-Self CBTI is the first listed.
NCT03727438 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03727438 about?
NCT03727438 is a clinical study titled "Tele-Self CBTI Trial". Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia has been shown to play a causal role in mental health, hypertension, obesity, and other health conditions, increasing risk for all-cause mortality. Cognitive-Behavioral Therapy for...
What is the current status of trial NCT03727438?
This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2019-10-04. Estimated completion is 2023-04-01.
What interventions are being tested in trial NCT03727438?
The interventions under investigation include: Tele-Self CBTI (BEHAVIORAL), Health Education Control (OTHER).
Who is sponsoring clinical trial NCT03727438?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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