Tele-Self CBTI Trial
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About
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.
Full description
Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia diagnoses increased 19-fold among military service members from 2000 to 2009. Insomnia has been shown to play a causal role in depression, anxiety, suicidality, disability due to a mental health disorder, hypertension, obesity, metabolic syndrome, diabetes, and all-cause mortality, thus serving as an additional risk factor for some of the most common medical conditions seen in patients utilizing the VA healthcare system. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than pharmacotherapy. But access to behavioral sleep medicine expertise within the VA is very limited.
Self-management and telehealth are viable options for achieving these goals. This study is a randomized controlled trial comparing Tele-Self CBTI to Health Education Control (HEC) for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this 2-arm trial, 200 participants will be randomized in a 1:1 ratio to Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; or c) referred for clinic-based CBTI (but not yet treated) will be identified using electronic health records (EHR) and telephone interviews.
Outcomes include insomnia severity in addition to subjective (sleep diary) and objective (actigraphy) measures of sleep variables, including: sleep onset latency (SOL), wakefulness after sleep onset (WASO), and sleep efficiency (SE). These outcomes will be assessed at 3 time points: baseline, 8 weeks, and 6 months after baseline. Participants in both arms will continue to receive usual medical care. Each assessment period involves: a) 2 weeks of home-based sleep assessment (diary and actigraphy), and b) completion of telephone-based questionnaires. Following completion of each home-based sleep assessment period, a study staff member will contact participants to complete study questionnaires by phone. Study participants will be asked to return actigraphy devices at the end of each assessment period.
Tele-Self CBTI is comprised of two treatment components: 1) Self-directed treatment via a treatment manual entitled, "Improve your Sleep: A Self-Guided Approach for Veterans with Insomnia" and 2) telephone-based nurse support. Participants will complete 6 weekly reading modules from the treatment manual on topics reflecting typical CBTI treatment components: Sleep Restriction; Stimulus Control; Cognitive Therapy; Relaxation; and Sleep Hygiene Education. Tele-Self CBTI will be delivered across 6 weekly telephone contacts of 20 minutes or less through a study nurse who will briefly review treatment manual content with the participant, review sleep diaries, and create and adjust sleep prescriptions as needed. Patients randomized to Health Education Control (HEC) will completed weekly readings and receive 6 weekly phone calls from a study nurse. Consistent with phone contacts in the intervention arm, HEC phone contacts will involve reviewing content in the health education manual and will last approximately 20 minutes; matching as closely as possible call duration with Tele-Self CBTI participants. Sleep-focused content will be prohibited during HEC calls. Participants have 8 weeks to complete the 6 phone calls.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Meets diagnostic criteria for Insomnia Disorder
- Receives care through the Durham VA Health Care System (HCS) catchment area
Exclusion criteria
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Severe Obstructive Sleep Apnea with treatment non-adherence
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Unstable co-morbid sleep disorder determined via chart review
- e.g., rule out for Narcolepsy, rule out for Shift Work Disorder
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Current or prior participation in Cognitive Behavioral Therapy for Insomnia (CBTI)
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Excessive daytime sleepiness
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Nighttime or rotating shift work within the last year
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Psychotic disorder diagnosis
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Bipolar disorder diagnosis
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Recreational substance use
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Current alcohol abuse
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Severe depression or suicidality
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Dementia diagnosis
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Cognitive impairment
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Epilepsy diagnosis
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Seizure disorder diagnosis
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Lack of proficiency in the English language
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Hearing impairment that impedes telehealth intervention
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Unable to complete study procedures
Trial design
Primary purpose
Allocation
Interventional model
Masking
178 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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