Internet-based Treatment for Chronic Insomnia

Phase 2

Completed

• Conditions: Insomnia; Insomnia Disorder
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT00821041
• Lead Sponsor: University of Manitoba

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Results First Submitted: 2011-05-05
• Results First Submitted QC: 2011-08-13
• Results First Posted: 2011-09-16
• Primary Completion: 2012-01
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	Cognitive Behavioral Therapy	A 6 weeks online course. Each week participants log on to view videos and read information that focus on a variety of intervention techniques. These include relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training. Participants also monitor their sleep using an online sleep diary and respond to questions regarding their adherence to the program.

Primary Outcome Measures

Name	Time	Method
Sleep Quality	6 weeks	Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?" And "How enjoyable was your sleep last night?" (0 = not at all, 4 = very).

Secondary Outcome Measures

Name	Time	Method
Beliefs and Attitudes About Sleep	6 weeks
Pre-Sleep Arousal	6 weeks	Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada