Back to resultsClinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
Primary Purpose
Insomnia, Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behaviour Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
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.
Sites / Locations
- North Glasgow and Grampian Trusts
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00134108
First Posted
August 23, 2005
Last Updated
October 25, 2005
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Cancer Research UK
1. Study Identification
Unique Protocol Identification Number
NCT00134108
Brief Title
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
Official Title
Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2003
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
Cancer Research UK
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behaviour Therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Espie, PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Glasgow and Grampian Trusts
City
Glasgow and Aberdeen
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
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