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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: In-person Cognitive Behavioral Therapy of Insomnia
* Behavioral: Internet Cognitive Behavioral Therapy of Insomnia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person CBT of Insomnia<br>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. | Behavioral: In-person Cognitive Behavioral Therapy of Insomnia<br>* 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).<br>|
| Active Comparator: Internet CBT of Insomnia<br>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. | Behavioral: Internet Cognitive Behavioral Therapy of Insomnia<br>* 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.<br>|
| No Intervention: Minimal Contact<br>Those assigned to the MC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week MC period. They will be called every other week to monitor their status and to provide support as needed. The calls will be limited to 10-15 minutes. MC participants will also be given contact information to use in case of worsening of symptoms or increasing distress. At the end of six weeks, they will complete the baseline assessments again, which will serve as the post-treatment assessment for the MC period. They will then be randomly assigned to either the CBTi or ICBTi groups. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Diary | 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. | Change from Baseline to Post-Treatment and 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory II | Measure of self-reported depression symptoms. | 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. | 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. | 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. | Change from Baseline to Post-Treatment and 6 month follow-up | 
| Beck Anxiety Inventory | Self-report measure of anxiety symptoms | Change from Baseline to Post-Treatment and 6 month follow-up | 
| Insomnia Severity Index | Self-report insomnia symptoms. | Change from Baseline to Post-Treatment and 6 month follow-up | 
| Epworth Sleepiness Scale | Self-report daytime sleepiness. | 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. | Change from Baseline to Post-Treatment and 6 month follow-up | 
| Multidimensional Fatigue Inventory | Self-reported fatigue symptoms across multiple dimensions. | Change from Baseline to Post-Treatment and 6 month follow-up | 
| Veterans Rand 12-Item Health Survey | Self-reported quality of life and health. | Change from Baseline to Post-Treatment and 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Cognitive, Behavioral, Internet, Depression, Substance Use, Therapy, Post-Tramatic Stress Disorder