Internet-based Treatment for Chronic Insomnia

• Sponsor: University of Manitoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT00821041
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Arms: 2
• Duration (Months): 81
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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

• Study Type: Interventional
• 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: Sep 1, 2006
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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 Names: CBT

Outcome Measures

Primary Outcome Measures

1. Sleep Quality [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 [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 [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Manitoba	Winnipeg	Manitoba	Canada	R3E 3N4

Sponsors and Collaborators

• University of Manitoba

Investigators

• Principal Investigator: Norah Vincent, Ph.D., University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Nora Vincent, Associate Professor, University of Manitoba
• ClinicalTrials.gov Identifier: NCT00821041
• Other Study ID Numbers: H2004:112; HSCF 176
• First Posted: Jan 12, 2009
• Last Update Posted: Aug 8, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Dr. Nora Vincent, Associate Professor, University of Manitoba: insomnia; online systems
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	Waiting List Control	Cognitive Behavioral Therapy
Arm/Group Description
Period Title: Overall Study
STARTED	59	59
COMPLETED	59	59
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Waiting List Control	Cognitive Behavioral Therapy	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	59	59	118
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	50.45 (13.26)	48.56 (11.39)	49.54 (12.32)
Sex: Female, Male (Count of Participants)
Female	39 66.1%	40 67.8%	79 66.9%
Male	20 33.9%	19 32.2%	39 33.1%
Total Sleep Time (Hours) [Mean (Full Range) ]
Mean (Full Range) [Hours]	5.54	5.61	5.58

Outcome Measures

1. Primary Outcome

Title	Sleep Quality
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Waiting List Control	Cognitive Behavioral Therapy
Arm/Group Description
Measure Participants	59	59
Mean (Standard Deviation) [0-4 scale of sleep quality]	1.77 (0.77)	2.18 (0.87)

2. Secondary Outcome

Title	Pre-Sleep Arousal
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Waiting List Control	Cognitive Behavioral Therapy
Arm/Group Description
Measure Participants	59	59
Mean (Standard Deviation) [PSA Scale]	25.46 (7.53)	22.42 (7.97)

3. Secondary Outcome

Title	Beliefs and Attitudes About Sleep
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Waiting List Control		Cognitive Behavioral Therapy
Arm/Group Description
All Cause Mortality
	Waiting List Control		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Waiting List Control		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/59 (0%)
Other (Not Including Serious) Adverse Events
	Waiting List Control		Cognitive Behavioral Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.