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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549899
• Other study ID #: W81XWH-10-1-0828
• Secondary ID: PT090525
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2012
• Last updated: May 5, 2016
• Start date: March 2012
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: University of North Texas, Denton, TX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Carl R. Darnall Army Medical Center	Fort Hood	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Dr. Daniel Taylor	C.R.Darnall Army Medical Center, The University of Texas Health Science Center at San Antonio, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Beck Depression Inventory II	Measure of self-reported depression symptoms.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Substance use	Self-reported use of sleep medications, caffeine, and nicotine obtained during the interview and on sleep diaries.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	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.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	PTSD Check List-Military	Measures self-reported Post-Traumatic Stress Disorders symptoms in military personnel.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Beck Anxiety Inventory	Self-report measure of anxiety symptoms	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Insomnia Severity Index	Self-report insomnia symptoms.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Epworth Sleepiness Scale	Self-report daytime sleepiness.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Dysfunctional Beliefs and Attitudes About Sleep Scale	Self-reported beliefs and attitudes about sleep.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Multidimensional Fatigue Inventory	Self-reported fatigue symptoms across multiple dimensions.	Change from Baseline to Post-Treatment and 6 month follow-up	No
Secondary	Veterans Rand 12-Item Health Survey	Self-reported quality of life and health.	Change from Baseline to Post-Treatment and 6 month follow-up	No