Self-help Treatment for Insomnia in Breast Cancer Patients

Laval University

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: placebo; Behavioral: self-administered form of cognitive-behavioral therapy; Behavioral: professionally administered cognitive-behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00674830

017738

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

professionally administered cognitive-behavioral therapy

Treatment:

Behavioral: professionally administered cognitive-behavioral therapy

2

Experimental group

Description:

self-administered form of cognitive behavioral therapy

Treatment:

Behavioral: self-administered form of cognitive-behavioral therapy

3

Placebo Comparator group

Description:

usual care

Treatment:

Behavioral: placebo