NCT01162655

Brief Summary

Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

December 22, 2009

Last Update Submit

May 25, 2017

Conditions

Keywords

InsomniaCognitive-Behavioral TherapyInternetTelehealth

Outcome Measures

Primary Outcomes (1)

  • Insomnia Severity

    The primary outcome measure will be insomnia severity, as assessed by the Insomnia Severity Index (ISI; Morin, 2003), a 6-item self-report measure of impairment due to sleep difficulties

    6 weeks

Secondary Outcomes (1)

  • Sleep diary data

    6 weeks

Study Arms (2)

Telehealth

EXPERIMENTAL

Complete CBT group via telehealth

Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)

Internet

EXPERIMENTAL

Complete Internet-based CBT program

Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)

Interventions

6-week course of CBT delivered either using internet or telehealth

InternetTelehealth

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be residents of rural Manitoba (Canada)
  • Must meet research diagnostic criteria for insomnia
  • Must have access to a computer and high-speed internet

You may not qualify if:

  • Comorbid conditions (medical and psychiatric) must be stable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3E 3N4, Canada

Location

Related Publications (1)

  • Holmqvist M, Vincent N, Walsh K. Web- vs. telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014 Feb;15(2):187-95. doi: 10.1016/j.sleep.2013.10.013. Epub 2013 Dec 31.

    PMID: 24461370BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Maxine Holmqvist, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist & Assistant Professor

Study Record Dates

First Submitted

December 22, 2009

First Posted

July 14, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations