NCT00134108

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

October 26, 2005

Status Verified

January 1, 2003

First QC Date

August 23, 2005

Last Update Submit

October 25, 2005

Conditions

InsomniaCancer

Interventions

Cognitive Behaviour TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets clinical criteria for insomnia.
  • Diagnosis of breast, prostate, colorectal or gynaecological cancer.
  • In follow-up phase with no further anti-cancer therapy planned.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Glasgow and Grampian Trusts

Glasgow and Aberdeen, United Kingdom

Location

Related Publications (1)

  • Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

    PMID: 41170811DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersNeoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Colin Espie, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 24, 2005

Study Start

January 1, 2003

Study Completion

December 1, 2005

Last Updated

October 26, 2005

Record last verified: 2003-01

Locations

GB(1)