Internet-based Treatment for Chronic Insomnia
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|ClinicalTrials.gov Identifier: NCT00821041|
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : September 16, 2011
Last Update Posted : August 8, 2013
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 are adults in Manitoba Canada with chronic insomnia.
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.
|Condition or disease||Intervention/treatment||Phase|
|Insomnia Insomnia Disorder||Behavioral: Cognitive Behavioral Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of an Internet-based Treatment for Chronic Insomnia|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||June 2013|
|No Intervention: Waiting list control|
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.
Behavioral: Cognitive Behavioral Therapy
6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
Other Name: CBT
- Sleep Quality [ Time Frame: 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).
- Pre-Sleep Arousal [ Time Frame: 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.
- Beliefs and Attitudes About Sleep [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821041
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R3E 3N4|
|Principal Investigator:||Norah Vincent, Ph.D.||University of Manitoba|