N/A
Completed N=178
Tele-Self CBTI Trial
Source: ClinicalTrials.gov NCT03727438 ↗Enrolled (actual)
178
Serious AEs
17.4%
Results posted
Sep 2024
Primary outcomePrimary: Insomnia Severity — 16.1; 16.1; 10.4; 14.1 ISI score — p=<0.01
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 to HEC and interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity |
16.1; 16.1; 10.4; 14.1 | <0.01 sig |
| SECONDARY Subjective Sleep Onset Latency (SOL) |
49.4; 49.4; 26.5; 46.1 | <0.01 sig |
| SECONDARY Subjective Wake After Sleep Onset (WASO) |
58.8; 58.8; 33.5; 54.0 | <0.01 sig |
| SECONDARY Subjective Sleep Efficiency (SE) |
65.4; 65.4; 79.0; 68.0 | <0.01 sig |
| SECONDARY Objective Wake After Sleep Onset |
48.7; 48.7; 48.7; 54.9 | > 0.05 |
| SECONDARY Objective Total Sleep Time (TST) |
5.9; 5.9; 6.2; 6.2 | >0.05 |
| SECONDARY Objective Sleep Efficiency (SE) |
86.3; 86.3; 87.0; 85.4 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Meets diagnostic criteria for Insomnia Disorder
- Receives care through the Durham VA Health Care System (HCS) catchment area
Exclusion Criteria
- Severe Obstructive Sleep Apnea with treatment non-adherence
- Unstable co-morbid sleep disorder determined via chart review
- e.g., rule out for Narcolepsy, rule out for Shift Work Disorder
- Current or prior participation in Cognitive Behavioral Therapy for Insomnia (CBTI)
- Excessive daytime sleepiness
- Nighttime or rotating shift work within the last year
- Psychotic disorder diagnosis
- Bipolar disorder diagnosis
- Recreational substance use
- Current alcohol abuse
- Severe depression or suicidality
- Dementia diagnosis
- Cognitive impairment
- Epilepsy diagnosis
- Seizure disorder diagnosis
- Lack of proficiency in the English language
- Hearing impairment that impedes telehealth intervention
- Unable to complete study procedures
Data sourced from ClinicalTrials.gov (NCT03727438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.