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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
Sponsor:
Information provided by (Responsible Party):
Dr. Nora Vincent, University of Manitoba

Study Description
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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.


Condition or disease Intervention/treatment Phase
Insomnia Insomnia Disorder Behavioral: Cognitive Behavioral Therapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Beliefs and Attitudes About Sleep [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3N4
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Norah Vincent, Ph.D. University of Manitoba
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Nora Vincent, Associate Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT00821041    
Other Study ID Numbers: H2004:112
HSCF 176
First Posted: January 12, 2009    Key Record Dates
Results First Posted: September 16, 2011
Last Update Posted: August 8, 2013
Last Verified: August 2013
Keywords provided by Dr. Nora Vincent, University of Manitoba:
insomnia
online systems
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders