Internet-Based Treatment for Chronic Insomnia - Full Text View

Sponsored by:	University of Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00821041

Purpose

Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 5-week, online treatment for insomnia.

Design This is a randomized controlled trial with online treatment and waiting list control conditions.

Participants

Participants are adults 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, 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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
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: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pre-Sleep Arousal [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Beliefs and Attitudes about Sleep [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Waiting list control: No Intervention
CBT: Experimental	Behavioral: Cognitive Behavioral Therapy 5 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821041

Contacts

Contact: Kate H Swain, B.A.	204-787-5098	khartswain@gmail.com
Contact: Sharon Dennis	204-787-5161	SDennis@exchange.hsc.mb.ca

Locations

Canada, Manitoba
University of Manitoba	Recruiting
Winnipeg, Manitoba, Canada, R3E 3N4
Contact: Shelley Rempel-Rossum 204-789-3389 remross@cc.umanitoba.ca
Principal Investigator: Norah Vincent, Ph.D.

Sponsors and Collaborators

University of Manitoba

Investigators

Principal Investigator:

Norah Vincent, Ph.D.

University of Manitoba

More Information

Responsible Party:	U of Manitoba ( Dr. Norah Vincent )
Study ID Numbers:	H2004:112, HSCF 176
Study First Received:	January 8, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00821041
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Manitoba:

insomnia
online systems

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009