Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:42 PM
Study NCT ID:
NCT00134108
Status:
UNKNOWN
Last Update Posted:
2005-10-26
First Post:
2005-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-01', 'completionDateStruct': {'date': '2005-12'}, 'lastUpdateSubmitDate': '2005-10-25', 'studyFirstSubmitDate': '2005-08-23', 'studyFirstSubmitQcDate': '2005-08-23', 'lastUpdatePostDateStruct': {'date': '2005-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Insomnia', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '41170811', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a formal controlled evaluation of the potential benefits of CBT for insomnia in cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets clinical criteria for insomnia.\n* Diagnosis of breast, prostate, colorectal or gynaecological cancer.\n* In follow-up phase with no further anti-cancer therapy planned.\n\nExclusion Criteria:\n\n* Anti-cancer chemotherapy or radiotherapy within 4 weeks of trial entry.\n* Evidence of sleep apnoea or other sleep disorder.\n* Evidence of untreated major depressive disorder.'}, 'identificationModule': {'nctId': 'NCT00134108', 'briefTitle': 'Clinical Benefit of Cognitive Behaviour Therapy (CBT) for Insomnia in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Clyde and Glasgow'}, 'officialTitle': 'Randomised Controlled Clinical Effectiveness Trial of Cognitive Behaviour Therapy (CBT) Versus Treatment as Usual (TAU) for Insomnia in Cancer Patients', 'orgStudyIdInfo': {'id': 'C8265/A3036'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive Behaviour Therapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glasgow and Aberdeen', 'country': 'United Kingdom', 'facility': 'North Glasgow and Grampian Trusts'}], 'overallOfficials': [{'name': 'Colin Espie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Research UK', 'class': 'OTHER'}]}}}