Phase 2 N=118 Randomized Single-blind Treatment

Internet-based Treatment for Chronic Insomnia

Insomnia · Insomnia Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00821041 ↗

Enrolled (actual)

118

Serious AEs

0.0%

Results posted

Sep 2011

Primary outcome: Primary: Sleep Quality — 1.77; 2.18 0-4 scale of sleep quality

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cognitive Behavioral Therapy (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Manitoba
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Quality	1.77; 2.18	—
SECONDARY Pre-Sleep Arousal	25.46; 22.42	—
SECONDARY Beliefs and Attitudes About Sleep	—	—

Summary

Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia. Design This is a randomized controlled trial with online treatment and waiting list control conditions. Participants Participants are adults in Manitoba Canada with chronic insomnia. Setting Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.

Eligibility Criteria

Inclusion Criteria

Access to high speed internet, insomnia duration > 6 months and occurring at least 4 nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30 minutes, and/or early morning awakening > 30 minutes before desired time, at least one type of daytime impairment.

Exclusion Criteria

Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14 drinks/week for males, > 12 drinks per week for females, current or past behavioral treatment for insomnia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00821041). 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.