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

Phase 3

Completed

Conditions: Insomnia

Interventions: Behavioral: In-person Cognitive Behavioral Therapy of Insomnia
Behavioral: Internet Cognitive Behavioral Therapy of 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

Arm && Interventions

Group	Intervention	Description
In-person CBT of Insomnia	In-person Cognitive Behavioral Therapy of Insomnia	CBTi consisted of 6 weekly 60-minute sessions and included identical informational material. The treatments contained the following efficacious and commonly used modules of cognitive behavioral treatments for insomnia: Stimulus Control, Sleep Restriction, Sleep Hygiene, Relaxation Training, Cognitive Restructuring.
Internet CBT of Insomnia	Internet Cognitive Behavioral Therapy of Insomnia	The I-CBTi protocol was developed by the National Center for Telehealth and Technology with the first author (DJT) serving as the subject matter expert, and administered on the afterdeployment.org website. The information and instructions for I-CBTi were identical to in-person CBTi; however, their mode of delivery in I-CBTi is considerably different due to the constraints of its automated, online format. The lessons were presented as audio recordings accompanied by visual graphics and animations and several lessons, had interactive components such as games, quizzes, and prompts for participants to schedule healthy sleep habits.

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
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.
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.
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.
Beck Anxiety Inventory	Change from Baseline to Post-Treatment and 6 month follow-up	Self-report measure of anxiety symptoms
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.
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.
Veterans Rand 12-Item Health Survey	Change from Baseline to Post-Treatment and 6 month follow-up	Self-reported quality of life and health.