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

This study has been completed.
Sponsor:
Collaborators:
United States Department of Defense
C.R.Darnall Army Medical Center
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Dr. Daniel Taylor, University of North Texas, Denton, TX
ClinicalTrials.gov Identifier:
NCT01549899
First received: February 4, 2012
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Insomnia
Behavioral: In-person Cognitive Behavioral Therapy of Insomnia
Behavioral: Internet Cognitive Behavioral Therapy of Insomnia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia

Further study details as provided by University of North Texas, Denton, TX:

Primary Outcome Measures:
  • Sleep Diary [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Measure of self-reported depression symptoms.

  • Substance use [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.

  • Actigraphy [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.

  • Beck Anxiety Inventory [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-report measure of anxiety symptoms

  • Insomnia Severity Index [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-report insomnia symptoms.

  • Epworth Sleepiness Scale [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-report daytime sleepiness.

  • Dysfunctional Beliefs and Attitudes About Sleep Scale [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-reported beliefs and attitudes about sleep.

  • Multidimensional Fatigue Inventory [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-reported fatigue symptoms across multiple dimensions.

  • Veterans Rand 12-Item Health Survey [ Time Frame: Change from Baseline to Post-Treatment and 6 month follow-up ] [ Designated as safety issue: No ]
    Self-reported quality of life and health.


Enrollment: 187
Study Start Date: March 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549899

Locations
United States, Texas
Carl R. Darnall Army Medical Center
Fort Hood, Texas, United States, 76544
Sponsors and Collaborators
Dr. Daniel Taylor
United States Department of Defense
C.R.Darnall Army Medical Center
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Daniel J Taylor, Ph.D. University of North Texas Health Science Center
  More Information

Responsible Party: Dr. Daniel Taylor, Associate Professor, University of North Texas, Denton, TX
ClinicalTrials.gov Identifier: NCT01549899     History of Changes
Other Study ID Numbers: W81XWH-10-1-0828  PT090525 
Study First Received: February 4, 2012
Last Updated: May 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Texas, Denton, TX:
Insomnia
Cognitive
Behavioral
Therapy
Internet
Depression
Substance Use
Post-Tramatic Stress Disorder

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on December 09, 2016