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

Conditions

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

  • United Kingdom
      • Glasgow and Aberdeen, United Kingdom
        • North Glasgow and Grampian Trusts

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

NHS Greater Glasgow and Clyde

Collaborators

Cancer Research UK

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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