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Trial Outcomes & Findings for Internet-based Treatment for Chronic Insomnia (NCT NCT00821041)

NCT ID: NCT00821041

Last Updated: 2013-08-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

118 participants

Primary outcome timeframe

6 weeks

Results posted on

2013-08-08

Participant Flow

Participant milestones

Participant milestones
Measure
Waiting List Control
Cognitive Behavioral Therapy
Overall Study
STARTED
59
59
Overall Study
COMPLETED
59
59
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Internet-based Treatment for Chronic Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Waiting List Control
n=59 Participants
Cognitive Behavioral Therapy
n=59 Participants
Total
n=118 Participants
Total of all reporting groups
Age Continuous
50.45 Years
STANDARD_DEVIATION 13.26 • n=5 Participants
48.56 Years
STANDARD_DEVIATION 11.39 • n=7 Participants
49.54 Years
STANDARD_DEVIATION 12.32 • n=5 Participants
Sex: Female, Male
Female
39 Participants
n=5 Participants
40 Participants
n=7 Participants
79 Participants
n=5 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
19 Participants
n=7 Participants
39 Participants
n=5 Participants
Total Sleep Time
5.54 Hours
n=5 Participants
5.61 Hours
n=7 Participants
5.58 Hours
n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Waiting List Control
n=59 Participants
Cognitive Behavioral Therapy
n=59 Participants
Sleep Quality
1.77 0-4 scale of sleep quality
Standard Deviation 0.77
2.18 0-4 scale of sleep quality
Standard Deviation 0.87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Waiting List Control
n=59 Participants
Cognitive Behavioral Therapy
n=59 Participants
Pre-Sleep Arousal
25.46 PSA Scale
Standard Deviation 7.53
22.42 PSA Scale
Standard Deviation 7.97

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome data not reported

Adverse Events

Waiting List Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cognitive Behavioral Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Coordinator

University of Manitoba

Phone: 204-787-5098

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place