Tele-Self CBTI Trial
Public ClinicalTrials.gov record NCT03727438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self-CBTI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 to HEC and interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.
Study identification
- NCT ID
- NCT03727438
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 178 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 3, 2019
- Primary completion
- Dec 15, 2022
- Completion
- Mar 31, 2023
- Last update posted
- Sep 23, 2024
2019 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705-3875 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03727438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 23, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03727438 live on ClinicalTrials.gov.