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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of North Texas, Denton, TX.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
C.R.Darnall Army Medical Center
University of Texas
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: April 5, 2012
Last verified: April 2012

February 4, 2012
April 5, 2012
March 2012
September 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01549899 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparing Internet and In-Person Brief Cognitive Behavioral Therapy of Insomnia
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 wait-list-control (WLC), 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 (63 per group) military personnel with chronic insomnia, aged 18-65, will be recruited and randomized to receive 6-sessions (over 6 weeks) of CBTi, Internet CBTi, or a wait list control condition. The investigators will compare these three groups on subjective and objective measures of sleep and other variables of interest (e.g., depression, substance abuse, and PTSD symptoms). To date, The investigators have hired all research personnel, built the 6-session internet treatment, trained and certified therapists in the in-person treatment, finalized measures, received preliminary approval by HARPO, UTHSCSA IRB, UNT IRB, and are awaiting the final approval letter from the investigators April 8, 2011 submission to the BAMC IRB. In addition, the investigators core database has been built. The investigators are now awaiting final approval from the IRBs before the investigators launch the study.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Insomnia
  • Behavioral: In-person Cognitive Behavioral Therapy of Insomnia
    In-person CBTi will be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consists of 6-sessions and will include the same efficacious and commonly used modules of CBTi (i.e., sleep education & hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive re-structuring).
  • Behavioral: Internet Cognitive Behavioral Therapy of Insomnia
    The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology. The treatment consists of the same components as the in-person CBTi, but their mode of delivery is considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions is divided into lessons covering different aspects of each of the components. The lessons are presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components are included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits. Patients can print out reviews of each session, instructions for relaxation, and written handouts with accompanying graphics and diagrams for each treatment.
  • Active Comparator: In-person CBT of Insomnia
    Intervention: Behavioral: In-person Cognitive Behavioral Therapy of Insomnia
  • Active Comparator: Internet CBT of Insomnia
    Intervention: Behavioral: Internet Cognitive Behavioral Therapy of Insomnia
  • No Intervention: Wait List Control/Minimal Contact
    Those assigned to the WLC control group will be asked to not work with another therapist or seek additional treatment for insomnia-related difficulties during the 6-week WLC 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. WLC 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 WLC period. They will then be randomly assigned to either the CBTi or ICBTi groups.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
189
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Sonia Holleman, BS 254-432-4169 sonia.holleman@amedd.army.mil
Contact: Jamie Anderson, BA (254) 288-1360 Jamie.Anderson@amedd.army.mil
United States
 
NCT01549899
W81XWH-10-1-0828, PT090525
Yes
Dr. Daniel Taylor, University of North Texas, Denton, TX
Dr. Daniel Taylor
  • Department of Defense
  • C.R.Darnall Army Medical Center
  • University of Texas
Principal Investigator: Daniel J Taylor, Ph.D. University of North Texas Health Science Center
University of North Texas, Denton, TX
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP