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Completed

NCT Number: NCT01549899

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.

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Key information

Conditions

Insomnia Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-person Cognitive Behavioral Therapy of Insomnia

Behavioral

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).

Internet Cognitive Behavioral Therapy of Insomnia

Behavioral

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 outcomes

  1. Sleep Diary Sleep Efficiency

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    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 outcomes

  1. Beck Depression Inventory II

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Measure of self-reported depression symptoms.

  2. Substance Use

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.

  3. Actigraphy

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    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.

  4. PTSD Check List-Military

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.

  5. Beck Anxiety Inventory

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-report measure of anxiety symptoms

  6. Insomnia Severity Index

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-report insomnia symptoms.

  7. Epworth Sleepiness Scale

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-report daytime sleepiness.

  8. Dysfunctional Beliefs and Attitudes About Sleep Scale

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-reported beliefs and attitudes about sleep.

  9. Multidimensional Fatigue Inventory

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-reported fatigue symptoms across multiple dimensions.

  10. Veterans Rand 12-Item Health Survey

    Time frame: Change from Baseline to Post-Treatment and 6 month follow-up

    Self-reported quality of life and health.

Sponsors and collaborators

Lead sponsor

Daniel J. Taylor, Ph.D.

Other

Collaborators

  • C.R.Darnall Army Medical Center
  • The University of Texas Health Science Center at San Antonio
  • United States Department of Defense

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2012
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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