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Self-help Treatment for Insomnia in Breast Cancer Patients

NCT ID: NCT00674830

Last Updated: 2013-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-08-31

Brief Summary

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The main goal of this population-based study is to assess the efficacy of two forms of cognitive-behavioral therapy (CBT) to treat various levels of insomnia symptoms in women with breast cancer: a professionally administered form and a patient self-administered form. It is hypothesized that the two treatment conditions will be associated with significantly greater improvements in sleep, psychological distress, fatigue, cognitive functioning, and quality of life, relative to the control condition (i.e., usual care). It is also hypothesized that the magnitude of effect sizes obtained in association with treatment at each time assessment will be greater for the professionally administered treatment than the self-administered treatment.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

professionally administered cognitive-behavioral therapy

Group Type EXPERIMENTAL

professionally administered cognitive-behavioral therapy

Intervention Type BEHAVIORAL

professionally administered CBT-I consisting of six weekly sessions

2

self-administered form of cognitive behavioral therapy

Group Type EXPERIMENTAL

self-administered form of cognitive-behavioral therapy

Intervention Type BEHAVIORAL

self-administered CBT-I consisting of six short booklets and videotapes

3

usual care

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BEHAVIORAL

usual care

Interventions

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professionally administered cognitive-behavioral therapy

professionally administered CBT-I consisting of six weekly sessions

Intervention Type BEHAVIORAL

self-administered form of cognitive-behavioral therapy

self-administered CBT-I consisting of six short booklets and videotapes

Intervention Type BEHAVIORAL

placebo

usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* To be receiving treatment for a diagnosis of breast or gynaecological cancer
* To obtain a score of 8 or higher on the Insomnia Severity Index (ISI) or to be using a hypnotic medication ≥ 1 night per week

Exclusion Criteria

* To have received a diagnosis or being treated for :

* a sleep disorder other than insomnia (e.g., sleep apnea)
* a severe psychiatric disorder (e.g., psychotic disorder)
* a severe cognitive disorder (e.g., dementia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Canadian Breast Cancer Research Alliance

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josée Savard, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche de l'HDQ

Locations

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Centre de recherche de l'HDQ

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Savard J, Ivers H, Savard MH, Morin CM. Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer. Sleep. 2016 Apr 1;39(4):813-23. doi: 10.5665/sleep.5634.

Reference Type DERIVED
PMID: 26715229 (View on PubMed)

Savard J, Ivers H, Savard MH, Morin CM. Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. Sleep. 2014 Aug 1;37(8):1305-14. doi: 10.5665/sleep.3918.

Reference Type DERIVED
PMID: 25083010 (View on PubMed)

Other Identifiers

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017738

Identifier Type: -

Identifier Source: org_study_id