Internet-based Treatment for Chronic Insomnia
This study is ongoing, but not recruiting participants.
Sponsor:
University of Manitoba
Information provided by (Responsible Party):
Dr. Nora Vincent, University of Manitoba
ClinicalTrials.gov Identifier:
NCT00821041
First received: January 8, 2009
Last updated: September 16, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia Insomnia Disorder |
Behavioral: Cognitive Behavioral Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of an Internet-based Treatment for Chronic Insomnia |
Further study details as provided by University of Manitoba:
Primary Outcome Measures:
- Sleep Quality [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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:
- Pre-Sleep Arousal [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Enrollment: | 118 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Waiting list control | |
|
Experimental: CBT
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Nora Vincent, Associate Professor, University of Manitoba |
| ClinicalTrials.gov Identifier: | NCT00821041 History of Changes |
| Other Study ID Numbers: | H2004:112, HSCF 176 |
| Study First Received: | January 8, 2009 |
| Results First Received: | May 5, 2011 |
| Last Updated: | September 16, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Manitoba:
|
insomnia online systems |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013