This trial is active, not recruiting.

Conditions insomnia, cancer
Treatment cognitive behaviour therapy
Sponsor NHS Greater Clyde and Glasgow
Collaborator Cancer Research UK
Start date January 2003
End date December 2005
Trial identifier NCT00134108, C8265/A3036


The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Meets clinical criteria for insomnia. - Diagnosis of breast, prostate, colorectal or gynaecological cancer. - In follow-up phase with no further anti-cancer therapy planned. Exclusion Criteria: - Anti-cancer chemotherapy or radiotherapy within 4 weeks of trial entry. - Evidence of sleep apnoea or other sleep disorder. - Evidence of untreated major depressive disorder.

Additional Information

Official title Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients
Principal investigator Colin Espie, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2005.
Information provided to ClinicalTrials.gov by NHS Greater Clyde and Glasgow.