Phase 3 N=185 Randomized Single-blind Treatment

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

Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT01549899 ↗

Enrolled (actual)

185

Serious AEs

3.2%

Results posted

Apr 2025

Primary outcome: Primary: Sleep Diary Sleep Efficiency — 73.2; 72.5; 72.9; 84.5 Percentage Total Sleep Time/Time in Bed

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: In-person Cognitive Behavioral Therapy of Insomnia (Behavioral); Internet Cognitive Behavioral Therapy of Insomnia (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Daniel J. Taylor, Ph.D.
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Diary Sleep Efficiency	73.2; 72.5; 72.9; 84.5; 79.4; 73.1	—
SECONDARY Beck Depression Inventory II	—	—
SECONDARY Substance Use	—	—
SECONDARY Actigraphy	—	—
SECONDARY PTSD Check List-Military	—	—
SECONDARY Beck Anxiety Inventory	—	—
SECONDARY Insomnia Severity Index	—	—
SECONDARY Epworth Sleepiness Scale	—	—
SECONDARY Dysfunctional Beliefs and Attitudes About Sleep Scale	—	—
SECONDARY Multidimensional Fatigue Inventory	—	—
SECONDARY Veterans Rand 12-Item Health Survey	—	—

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT01549899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.