Back to resultsComparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
In-person Cognitive Behavioral Therapy of Insomnia
Internet Cognitive Behavioral Therapy of Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Cognitive, Behavioral, Therapy, Internet, Depression, Substance Use, Post-Tramatic Stress Disorder
Eligibility Criteria
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.
Sites / Locations
- Carl R. Darnall Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
In-person CBT of Insomnia
Internet CBT of Insomnia
Minimal Contact
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Beck Depression Inventory II
Measure of self-reported depression symptoms.
Substance use
Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.
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.
PTSD Check List-Military
Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Beck Anxiety Inventory
Self-report measure of anxiety symptoms
Insomnia Severity Index
Self-report insomnia symptoms.
Epworth Sleepiness Scale
Self-report daytime sleepiness.
Dysfunctional Beliefs and Attitudes About Sleep Scale
Self-reported beliefs and attitudes about sleep.
Multidimensional Fatigue Inventory
Self-reported fatigue symptoms across multiple dimensions.
Veterans Rand 12-Item Health Survey
Self-reported quality of life and health.
Full Information
NCT ID
NCT01549899
First Posted
February 4, 2012
Last Updated
May 5, 2016
Sponsor
Dr. Daniel Taylor
Collaborators
United States Department of Defense, C.R.Darnall Army Medical Center, The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT01549899
Brief Title
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
Official Title
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Daniel Taylor
Collaborators
United States Department of Defense, C.R.Darnall Army Medical Center, The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Cognitive, Behavioral, Therapy, Internet, Depression, Substance Use, Post-Tramatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
In-person CBT of Insomnia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internet CBT of Insomnia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Minimal Contact
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
In-person Cognitive Behavioral Therapy of Insomnia
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Internet Cognitive Behavioral Therapy of Insomnia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Diary
Description
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
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II
Description
Measure of self-reported depression symptoms.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Substance use
Description
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
Title
Actigraphy
Description
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
Title
PTSD Check List-Military
Description
Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Beck Anxiety Inventory
Description
Self-report measure of anxiety symptoms
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Insomnia Severity Index
Description
Self-report insomnia symptoms.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Epworth Sleepiness Scale
Description
Self-report daytime sleepiness.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Dysfunctional Beliefs and Attitudes About Sleep Scale
Description
Self-reported beliefs and attitudes about sleep.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Multidimensional Fatigue Inventory
Description
Self-reported fatigue symptoms across multiple dimensions.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
Title
Veterans Rand 12-Item Health Survey
Description
Self-reported quality of life and health.
Time Frame
Change from Baseline to Post-Treatment and 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Taylor, Ph.D.
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carl R. Darnall Army Medical Center
City
Fort Hood
State/Province
Texas
ZIP/Postal Code
76544
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29618098
Citation
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.
Results Reference
derived
PubMed Identifier
29458705
Citation
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.
Results Reference
derived
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Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
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