NCT00674830

Self-help Treatment for Insomnia in Breast Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	professionally administered cognitive-behavioral therapy	professionally administered CBT-I consisting of six weekly sessions
BEHAVIORAL	self-administered form of cognitive-behavioral therapy	self-administered CBT-I consisting of six short booklets and videotapes
BEHAVIORAL	placebo	usual care

Timeline

• Start date: 2008-04-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2008-05-08
• Last updated: 2013-08-15

Locations

1 site across 1 country: Canada