Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia

Phase 3

Completed

Conditions: Insomnia

Registration Number: NCT01549899

Lead Sponsor: Daniel J. Taylor, Ph.D.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 185

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep Diary Sleep Efficiency	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 Outcome Measures

Name	Time	Method
Actigraphy	Change from Baseline to Post-Treatment and 6 month follow-up	A wrist worn accelerometer that measures activity level and then uses validated algorithms to determine objectively daily bedtime, time to fall asleep, middle of the night awakenings, and time out of bed. These data will be aggregated to determine objective 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.
Beck Anxiety Inventory	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report measure of anxiety symptoms
Dysfunctional Beliefs and Attitudes About Sleep Scale	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported beliefs and attitudes about sleep.
Multidimensional Fatigue Inventory	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported fatigue symptoms across multiple dimensions.
Beck Depression Inventory II	Change from Baseline to Post-Treatment and 6 month follow-up	Measure of self-reported depression symptoms.
Substance Use	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.
PTSD Check List-Military	Change from Baseline to Post-Treatment and 6 month follow-up	Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Insomnia Severity Index	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report insomnia symptoms.
Epworth Sleepiness Scale	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report daytime sleepiness.
Veterans Rand 12-Item Health Survey	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported quality of life and health.

Trial Locations

Locations (1): Carl R. Darnall Army Medical Center
🇺🇸
Fort Hood, Texas, United States
Carl R. Darnall Army Medical Center
🇺🇸Fort Hood, Texas, United States