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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Insomnia
Insomnia Disorder
Intervention Behavioral: Cognitive Behavioral Therapy
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Waiting List Control Cognitive Behavioral Therapy
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 59 59
Completed 59 59
Not Completed 0 0
Arm/Group Title Waiting List Control Cognitive Behavioral Therapy Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 59 59 118
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 118 participants
50.45  (13.26) 48.56  (11.39) 49.54  (12.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 118 participants
Female
39
  66.1%
40
  67.8%
79
  66.9%
Male
20
  33.9%
19
  32.2%
39
  33.1%
Total Sleep Time   [1] 
Mean (Full Range)
Unit of measure:  Hours
Number Analyzed 59 participants 59 participants 118 participants
5.54
(1.74 to 10.80)
5.61
(1.73 to 10.35)
5.58
(1.73 to 10.80)
[1]
Measure Description: Total sleep time is collected from patients self-report weekly sleep diaries. It is the length of time spent in bed minus sleep onset latency and time spent awake in bed.
1.Primary Outcome
Title Sleep Quality
Hide Description 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).
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Waiting List Control Cognitive Behavioral Therapy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: 0-4 scale of sleep quality
1.77  (0.77) 2.18  (0.87)
2.Secondary Outcome
Title Pre-Sleep Arousal
Hide Description 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Waiting List Control Cognitive Behavioral Therapy
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: PSA Scale
25.46  (7.53) 22.42  (7.97)
3.Secondary Outcome
Title Beliefs and Attitudes About Sleep
Hide Description [Not Specified]
Time Frame 6 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Waiting List Control Cognitive Behavioral Therapy
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Waiting List Control Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Waiting List Control Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Waiting List Control Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Coordinator
Organization: University of Manitoba
Phone: 204-787-5098
EMail: NVincent@exchange.hsc.mb.ca
Layout table for additonal information
Responsible Party: Dr. Nora Vincent, University of Manitoba
ClinicalTrials.gov Identifier: NCT00821041    
Other Study ID Numbers: H2004:112
HSCF 176
First Submitted: January 8, 2009
First Posted: January 12, 2009
Results First Submitted: May 5, 2011
Results First Posted: September 16, 2011
Last Update Posted: August 8, 2013