- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134108
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
October 25, 2005 updated by: NHS Greater Glasgow and Clyde
Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients
The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glasgow and Aberdeen, United Kingdom
- North Glasgow and Grampian Trusts
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Colin Espie, PhD, University of Glasgow
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion
December 1, 2005
Study Registration Dates
First Submitted
August 23, 2005
First Submitted That Met QC Criteria
August 23, 2005
First Posted (Estimate)
August 24, 2005
Study Record Updates
Last Update Posted (Estimate)
October 26, 2005
Last Update Submitted That Met QC Criteria
October 25, 2005
Last Verified
January 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C8265/A3036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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