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

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 Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: In-person Cognitive Behavioral Therapy of Insomnia; Behavioral: Internet Cognitive Behavioral Therapy of Insomnia

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Hood, Texas, United States, 76544
      • Carl R. Darnall Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-person CBT 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.	Behavioral: In-person Cognitive Behavioral Therapy of Insomnia; 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).
Active Comparator: Internet CBT 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.	Behavioral: Internet Cognitive Behavioral Therapy of Insomnia; 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.
No Intervention: Minimal Contact; 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?

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

Collaborators and Investigators

• Sponsor: Dr. Daniel Taylor
• Collaborators: United States Department of Defense; The University of Texas Health Science Center at San Antonio; C.R.Darnall Army Medical Center
• Investigators: Principal Investigator: Daniel J Taylor, Ph.D., University of North Texas Health Science Center

Publications and helpful links

General Publications

• Taylor DJ, Peterson AL, Pruiksma KE, Hale WJ, Young-McCaughan S, Wilkerson A, Nicholson K, Litz BT, Dondanville KA, Roache JD, Borah EV, Brundige A, Mintz J; STRONG STAR Consortium. Impact of cognitive behavioral therapy for insomnia disorder on sleep and comorbid symptoms in military personnel: a randomized clinical trial. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy069.
• Taylor DJ, Wilkerson AK, Pruiksma KE, Williams JM, Ruggero CJ, Hale W, Mintz J, Organek KM, Nicholson KL, Litz BT, Young-McCaughan S, Dondanville KA, Borah EV, Brundige A, Peterson AL; STRONG STAR Consortium. Reliability of the Structured Clinical Interview for DSM-5 Sleep Disorders Module. J Clin Sleep Med. 2018 Mar 15;14(3):459-464. doi: 10.5664/jcsm.7000.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 4, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Insomnia; Therapy; Substance Use; Cognitive; Behavioral; Internet; Post-Tramatic Stress Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: W81XWH-10-1-0828; PT090525 (Other Identifier: CDMRP)