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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
185
In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education \& hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States
Sleep Diary Sleep Efficiency
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.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Beck Depression Inventory II
Measure of self-reported depression symptoms.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Substance Use
Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Actigraphy
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.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
PTSD Check List-Military
Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Beck Anxiety Inventory
Self-report measure of anxiety symptoms
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Insomnia Severity Index
Self-report insomnia symptoms.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Epworth Sleepiness Scale
Self-report daytime sleepiness.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Dysfunctional Beliefs and Attitudes About Sleep Scale
Self-reported beliefs and attitudes about sleep.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Multidimensional Fatigue Inventory
Self-reported fatigue symptoms across multiple dimensions.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
Veterans Rand 12-Item Health Survey
Self-reported quality of life and health.
Time frame: Change from Baseline to Post-Treatment and 6 month follow-up
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