Insomnia
Conditions
Brief 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.
Interventions
BEHAVIORALprofessionally administered cognitive-behavioral therapy
professionally administered CBT-I consisting of six weekly sessions
BEHAVIORALself-administered form of cognitive-behavioral therapy
self-administered CBT-I consisting of six short booklets and videotapes
BEHAVIORALplacebo
usual care
Sponsors
Canadian Breast Cancer Research Alliance
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sleep diary indices, actigraphy, Insomnia Severity Index | pre-treatment, post-treatment, 3 follow-up |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ, MFI, CFQ, TCEIQ, HADS, DBAS, UHCSQ, costs | pre-treatement, post-treatment, 3 follow-up |
Countries
Canada
Outcome results
None listed