Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Daniel J. Taylor, Ph.D.
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- Sleep Diary Sleep Efficiency
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a Minimal Contact control (MC), within an active duty military population to determine the comparative benefits of these interventions on improvement in sleep as well as domains strongly related to insomnia such as depression, substance abuse, and PTSD symptoms. A total of 189 military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi (n=77), ICBTi (n=35), or a MC control (n=77) condition. The investigators will compare these three groups on subjective and objective measures of sleep. The CBTi and MC control groups will be compared on other variables of interest (e.g., depression, substance abuse, and PTSD symptoms) and predictors of outcomes.
Investigators
Daniel J. Taylor, Ph.D.
Professor
University of North Texas, Denton, TX
Eligibility Criteria
Inclusion Criteria
- •Chronic Insomnia as defined by Research Diagnostic Criteria (RDC) criteria41 Complaint of \> 3 months (chronic insomnia) of disturbed sleep \>3 nights/week (severe insomnia) as defined by at least one of the following as assessed by sleep diaries: Sleep Onset Latency of \>30 min (initial insomnia) and/or Wake After Sleep-Onset of \>30 min (middle insomnia) and/or Early Morning Awakening of \>30 min before the desired wakeup time (late insomnia) and Sleep Efficiency \< 85%
- •Active Duty military member stationed at Fort Hood as assessed by self-report.
- •History of having deployed in support of OIF or OEF as assessed by self-report. • Stable on psychotropic and/or hypnotic medications for at least one month as assessed by self-report and review of medical record.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Sleep Diary Sleep Efficiency
Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up
Provides daily self-reports of bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine self-reported sleep efficiency (i.e., total sleep time/time in bed X 100). Other variable to be extracted will include total sleep time and total wake time.
Secondary Outcomes
- Beck Depression Inventory II(Change from Baseline to Post-Treatment and 6 month follow-up)
- Substance Use(Change from Baseline to Post-Treatment and 6 month follow-up)
- Actigraphy(Change from Baseline to Post-Treatment and 6 month follow-up)
- PTSD Check List-Military(Change from Baseline to Post-Treatment and 6 month follow-up)
- Beck Anxiety Inventory(Change from Baseline to Post-Treatment and 6 month follow-up)
- Insomnia Severity Index(Change from Baseline to Post-Treatment and 6 month follow-up)
- Epworth Sleepiness Scale(Change from Baseline to Post-Treatment and 6 month follow-up)
- Dysfunctional Beliefs and Attitudes About Sleep Scale(Change from Baseline to Post-Treatment and 6 month follow-up)
- Multidimensional Fatigue Inventory(Change from Baseline to Post-Treatment and 6 month follow-up)
- Veterans Rand 12-Item Health Survey(Change from Baseline to Post-Treatment and 6 month follow-up)