Clinical trial NCT03365024: Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk (R-Vets Sleep)
Official title: Computerized Cognitive Behavioral Treatment for Insomnia: Improving Rural Veteran Access to Evidence-Based Treatment to Reduce Suicide Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Mental Health Functioning
Physical Health Functioning
Keywords: CBT-I
Insomnia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2017-12-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is a major problem among veteran populations. Insomnia impacts physical and mental health functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to CBT-I is severely limited by a lack of trained clinicians within the Veterans Health Administration (VHA). There is a critical need to offer innovative approaches to meet the demand and need for insomnia treatment. Leveraging technology to meet treatment demands is consistent with service delivery models based upon stepped care principles. This randomized controlled trial will determine whether a computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia symptoms and improving functioning compared to a computerized program control.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 89
2. Eligible to receive care through VA ECHCS
3. Reliable access to the Internet
4. English speaking
5. Able to provide informed consent
6. Current insomnia diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) criteria

Exclusion Criteria:

1. Currently enrolled in/participating in other intervention research studies
2. Other untreated sleep disorders (e.g., sleep apnea, periodic limb movement)
3. Currently receiving formal psychological treatment for insomnia (not including sleep medications)
4. Past 3 month change in schedule and/or dosage of medications that are designed to improve/impact sleep
5. History of Bipolar Disorder (with manic episodes), Schizophrenia, Schizoaffective Disorder, or a Psychotic Disorder
6. Untreated seizures or seizure disorder
7. Physical illness that is active, unstable, degenerative, and/or progressive
8. Currently pregnant or plan to become pregnant in the next 6 months
9. Irregular work schedule, shift work, and/or life changes (e.g., new baby) interfering with regular sleep patterns
10. Significant cognitive impairment, as determined by chart review and/or during screening, that would interfere with ability to engage in SHUTi
11. Current non-alcohol Substance Use Disorder, excluding Cannabis Use Disorder, as determined by chart review and/or self-report screen of drug use (\> 1 time) in past 3 months
12. Current alcohol use diagnosis, as determined by SCID 5 module, in the past 3 months

Primary outcomes:
measure: Change in Insomnia Symptom Severity; Time 1 to Time 2
timeFrame: Baseline and 9 weeks
measure: Change in Mental Health; Time 1 to Time 2
timeFrame: Baseline and 9 weeks
measure: Change in Physical Health ; Time 1 to Time 2
timeFrame: Baseline and 9 weeks
measure: Change in Insomnia Symptom Severity; Time 1 to Time 3
timeFrame: Baseline and 6 Months
measure: Change in Mental Health; Time 1 to Time 3
timeFrame: Baseline and 6 Months
measure: Change in Physical Health; Time 1 to Time 3
timeFrame: Baseline and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA
state: Colorado
Study officials:
affiliation: VHAECH
name: Sarra Nazem, PhD
role: PRINCIPAL_INVESTIGATOR
References: