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

This study is currently recruiting participants.
Verified April 2012 by University of North Texas, Denton, TX
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
  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 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.


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

Resource links provided by NLM:


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.


Estimated Enrollment: 189
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: In-person CBT of 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).
Active Comparator: Internet CBT of Insomnia 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549899

Contacts
Contact: Sonia Holleman, BS 254-432-4169 sonia.holleman@amedd.army.mil
Contact: Jamie Anderson, BA (254) 288-1360 Jamie.Anderson@amedd.army.mil

Locations
United States, Texas
Carl R. Darnall Army Medical Center Recruiting
Fort Hood, Texas, United States, 76544
Contact: Paul G Fowler, B.A.    254-288-1638    strongstar.crdamc@amedd.army.mil   
Principal Investigator: Bradley Evans, PsyD         
Sponsors and Collaborators
Dr. Daniel Taylor
C.R.Darnall Army Medical Center
University of Texas
Investigators
Principal Investigator: Daniel J Taylor, Ph.D. University of North Texas Health Science Center
  More Information

No publications provided

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: April 5, 2012
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 Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014