Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-25 @ 6:48 AM
Study NCT ID:
NCT03730532
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2018-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Self-help for Anxiety - a Patient Preference Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patient Preference Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2018-11-02', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Anxiety Inventory', 'timeFrame': 'Measured at screening, at 6 weeks, 12 weeks and 24 weeks', 'description': 'measuring change in anxiety at four time points'}], 'secondaryOutcomes': [{'measure': 'Generalised Anxiety Disorder - 7', 'timeFrame': 'Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up', 'description': 'measuring change in anxiety across the intervention and follow-up'}, {'measure': 'patient health questionnaire - 9', 'timeFrame': 'Measured at screening, weekly for 6 weeks, then at 12 week and 24 week follow-up', 'description': 'measuring change in depression across the intervention and follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Guided self help', 'Cognitive Analytic Therapy', 'Cognitive Behavioral Therapy'], 'conditions': ['Anxiety']}, 'referencesModule': {'references': [{'pmid': '37395600', 'type': 'DERIVED', 'citation': 'Kellett S, Bee C, Smithies J, Aadahl V, Simmonds-Buckley M, Power N, Dugen-Williams C, Fallon N, Delgadillo J. Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial. Br J Psychiatry. 2023 Sep;223(3):438-445. doi: 10.1192/bjp.2023.78.'}]}, 'descriptionModule': {'briefSummary': 'Supporting patients in exerting choice over their treatment is a central aspect of modern healthcare. In Improving Access to Psychological Therapies (IAPT) services, then patients treated at step 2 are only and always offered cognitive-behaviourally informed guided self-help (GSH), when they are deemed suitable for treatment at step 2 of IAPT services (termed CBT-GSH). Step 2 interventions are guided self-help (GSH) delivered by Psychological Wellbeing Practitioners (PWPs). Recently, a new type of GSH has been developed and found to be feasible and effective in IAPT services - this is called cognitive-analytic guided self-help (CAT-GSH). This research aims to test the efficacy of CAT-GSH by comparing outcomes over time achieved in both types of GSH and interviewing participants about their experience of the GSH. The methodology to support patient choice is a patient preference trial. In this method, then patients that meet inclusion criteria for the trial are offered and choose between either CAT-GSH and CBT-GSH. Those patients that are unconcerned with the type of treatment are randomised to either CAT-GSH or CBT-GSH. The primary outcome measure is the Beck Anxiety Inventory. No changes to the standard practice of the PWPs will occur during the trial, the trial will be situated in a standard IAPT service and be a therefore conducted in a routine practice setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients have self-referred or been referred by their GP or other health or social care professional for a step 2 intervention for treatment of a common mental health problem,\n* patients meet criteria for an anxiety disorder on MINI screening interview assessment and also met caseness on the BAI (as defined by a score of \\>10 on the BAI at assessment).\n* Patients want to engage in GSH to address the anxiety disorder\n* patients are motivated to engage in treatment and can attend six sessions of face-to-face GSH.\n\nExclusion Criteria:\n\n* engaging in any another IAPT step 2 interventions.\n* Do not meet criteria for an anxiety disorder as defined by the MINI and the BAI score.\n* Meet criteria for depression and a comorbid anxiety disorder, as identified by the BAI and MINI, where the depression is more severe and is the patient's main concern.\n* Have a severe/chronic mental health problem and are already involved in psychiatric or secondary care mental health services.\n* Have substance misuse issues that would interfere with engagement with the GSH.\n* Have a diagnosed learning disability that precludes engagement in GSH.\n* Have a diagnosis of social phobia or PTSD"}, 'identificationModule': {'nctId': 'NCT03730532', 'briefTitle': 'Guided Self-help for Anxiety - a Patient Preference Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sheffield'}, 'officialTitle': 'Comparing Cognitive-behavioural and Cognitive-analytic Guided Self-help for Anxiety; a Patient Preference Clinical Trial', 'orgStudyIdInfo': {'id': '240751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomised CBT', 'description': 'Cognitive Behavioural Therapy Guided Self Help', 'interventionNames': ['Other: Cognitive Behavioural Therapy Guided Self Help']}, {'type': 'EXPERIMENTAL', 'label': 'Randomised CAT', 'description': 'Cognitive Analytic Therapy Guided Self Help', 'interventionNames': ['Other: Cognitive Analytic Therapy Guided Self Help']}, {'type': 'EXPERIMENTAL', 'label': 'Preference CAT', 'description': 'Cognitive Analytic Therapy Guided Self Help', 'interventionNames': ['Other: Cognitive Analytic Therapy Guided Self Help']}, {'type': 'EXPERIMENTAL', 'label': 'Preference CBT', 'description': 'Cognitive Behavioural Therapy Guided Self Help', 'interventionNames': ['Other: Cognitive Behavioural Therapy Guided Self Help']}], 'interventions': [{'name': 'Cognitive Behavioural Therapy Guided Self Help', 'type': 'OTHER', 'description': '6-week manualised Cognitive Behavioural Therapy Guided Self Help', 'armGroupLabels': ['Preference CBT', 'Randomised CBT']}, {'name': 'Cognitive Analytic Therapy Guided Self Help', 'type': 'OTHER', 'description': '6-week manualised Cognitive Analytic Therapy Guided Self Help', 'armGroupLabels': ['Preference CAT', 'Randomised CAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OL11RU', 'city': 'Oldham', 'state': 'Lancashire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Charlotte Bee', 'role': 'CONTACT', 'email': 'charlotte.bee2@nhs.net', 'phone': '0161 7162777'}], 'facility': 'Oldham Healthy Minds IAPT', 'geoPoint': {'lat': 53.54051, 'lon': -2.1183}}], 'centralContacts': [{'name': 'Steve Kellett', 'role': 'CONTACT', 'email': 's.kellett@sheffield.ac.uk', 'phone': '+44114 222 6537'}, {'name': 'Emma Beattie-Edwards', 'role': 'CONTACT', 'email': 'ebeattieedwards1@sheffield.ac.uk'}], 'overallOfficials': [{'name': 'Steve Kellett', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sheffield'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sheffield', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trainee Clinical Psychologist', 'investigatorFullName': 'Emma Beattie-Edwards', 'investigatorAffiliation': 'University of Sheffield'}}}}