InsomniaNCT00134108
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
A study testing Cognitive Behaviour Therapy in people with Insomnia and Cancer, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Cognitive Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2003to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Meets clinical criteria for insomnia.
- Diagnosis of breast, prostate, colorectal or gynaecological cancer.
- In follow-up phase with no further anti-cancer therapy planned.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Glasgow and Grampian Trusts
Glasgow and Aberdeen
About this study
Official title: 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.
- Being tested
- Cognitive Behaviour Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startJan 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Investigators
- Colin Espie, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134108
- Sponsor's protocol ID
- C8265/A3036
- Status last verified
- Jan 2003
- First submitted
- 23 Aug 2005
- Last updated
- 26 Oct 2005
- Results posted
- No
Publications
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.
PubMed 41170811
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients
- ClinicalTrials.gov ID
- NCT00134108
- Acronym / sponsor ID
- C8265/A3036
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Jan 2003
- Study completion
- Dec 2005
- First posted
- 24 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets clinical criteria for insomnia.
- Diagnosis of breast, prostate, colorectal or gynaecological cancer.
- In follow-up phase with no further anti-cancer therapy planned.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behaviour Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2005.
- Derived from this study: PubMed 41170811Cai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Espie, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy in people with Insomnia and Cancer, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00134108, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2005.