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Internet-based Treatment for Chronic Insomnia

NCT ID: NCT00821041

Last Updated: 2013-08-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insomnia Insomnia Disorder

Keywords

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insomnia online systems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Waiting list control

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training

Interventions

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Cognitive Behavioral Therapy

6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Nora Vincent

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norah Vincent, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Vincent N, Walsh K, Lewycky S. Determinants of success for computerized cognitive behavior therapy: examination of an insomnia program. Behav Sleep Med. 2013;11(5):328-42. doi: 10.1080/15402002.2012.700662. Epub 2013 Jan 3.

Reference Type DERIVED
PMID: 23286463 (View on PubMed)

Other Identifiers

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HSCF 176

Identifier Type: -

Identifier Source: secondary_id

H2004:112

Identifier Type: -

Identifier Source: org_study_id