Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-29 @ 4:09 AM
Study NCT ID:
NCT05260060
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2022-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Youth Metacognitive Therapy Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Chief investigator, research assistants and statisticians will be blind to treatment allocation of participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other Feasibility Outcomes', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': 'Feasibility will also be assessed using referral rates (Baseline), recruitment and retention rates (Baseline, 20 week, 32 weeks and 44 weeks), participant attendance at treatment sessions, and willingness to be randomized to treatment.'}], 'primaryOutcomes': [{'measure': 'Revised Children Anxiety and Depression Scale - Short Version (RCADS)', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': 'Youth self-report questionnaire measuring total anxiety, total depression and total anxiety and depression.\n\nThis is a feasibility study and therefore it is not primarily powered to detect a difference (change in scores). The principal aim is to test the feasibility of a study using. Here we are testing the feasibility of using the measures (RCADS), therefore the measures will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Specifically, range in scores, number of complete measures, proportion of missing data. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment effects.'}], 'secondaryOutcomes': [{'measure': 'Strength and Difficulties Questionnaire (SDQ)', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': 'Measure of psychological well-being across five subscales: emotion, hyperactivity, conduct, peer relations and pro-social behaviour.\n\nFeasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.'}, {'measure': 'Metacognition Questionnaire - Adolescent Version (MCQ-A)', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': 'Measure of metacognitive beliefs across five subscales: positive beliefs about worry, negative beliefs about uncontrollability and danger, cognitive confidence, cognitive self-consciousness and cognitive control.\n\nFeasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.'}, {'measure': 'Mood & Feelings Questionnaire (MFQ)', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': 'Measure of depressive symptoms in 6-17 year olds.\n\nFeasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.'}, {'measure': 'Child Health Utility - 9D (CHU-9D)', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': 'Measure of paediatric quality of life using dimensions: worried, sad, pain, tired, annoyed, school/homework, sleep, daily routine, ability to join in activities.\n\nFeasibility of the measure will be assessed by monitoring descriptive data and the analysis of complete data once follow up has been completed. Analyses of outcomes (change) will focus on descriptive statistics and confidence intervals for treatment.'}, {'measure': 'Health and Social Case Service-Use Interview (SUI)', 'timeFrame': 'Baseline, 20 weeks follow up, 32 weeks follow up, 44 weeks follow up', 'description': "Assessment of the child's use of primary, secondary or community-based health and social care services and how often they have used the service in the last 16 weeks or since last study assessment."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metacognitive Therapy', 'Feasibility', 'Anxiety', 'Depression', 'Mental health'], 'conditions': ['Child Mental Disorder', 'Anxiety Disorders', 'Depression']}, 'referencesModule': {'references': [{'pmid': '36096940', 'type': 'DERIVED', 'citation': 'Wells A, Carter K, Hann M, Shields G, Wallis P, Cooper B, Capobianco L. Youth Metacognitive Therapy (YoMeta): protocol for a single-blind randomised feasibility trial of a transdiagnostic intervention versus treatment as usual in 11-16-year-olds with common mental health problems. Pilot Feasibility Stud. 2022 Sep 12;8(1):207. doi: 10.1186/s40814-022-01162-5.'}], 'seeAlsoLinks': [{'url': 'https://adept-ru.com/research-projects/yometa/', 'label': 'Research Project Website Page'}]}, 'descriptionModule': {'briefSummary': 'One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem. The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP.\n\nThe most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT).\n\nThe aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seeking treatment for emotional disorder symptoms (i.e. generalized anxiety disorder, panic disorder, agoraphobia, post-traumatic stress disorder, obsessive compulsive disorder, social anxiety and/or depression).\n* Native fluency in English language\n* Medication permitted but must be stabilised for 6 weeks.\n\nExclusion Criteria:\n\n* Presence of significant risk or safeguarding concerns\n* Head injury/organic impairment\n* Formal diagnosis or under assessment for Autism Spectrum Disorder or Attention Deficit-Hyperactivity Disorder\n* Eating Disorder'}, 'identificationModule': {'nctId': 'NCT05260060', 'acronym': 'YoMETA', 'briefTitle': 'Youth Metacognitive Therapy Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Youth Metacognitive Therapy (YoMETA): A Single-Blind Parallel Randomised Feasibility Trial', 'orgStudyIdInfo': {'id': 'IRAS ID: 296079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Treatment (Control)', 'description': 'Participants allocated to the control group will receive treatment as usual under the child and adolescent mental health service.', 'interventionNames': ['Behavioral: Treatment as usual: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Group MCT (Intervention)', 'description': 'Participants allocated to the intervention group will receive group metacognitive therapy sessions.', 'interventionNames': ['Behavioral: Group Metacognitive Therapy (Group-MCT): Experimental']}], 'interventions': [{'name': 'Treatment as usual: Control', 'type': 'BEHAVIORAL', 'description': 'Treatment usually delivered in service that may include but is not limited to cognitive behaviour therapy, exposure, eye movement desensitisation and reprocessing , behaviour therapy, family therapy.', 'armGroupLabels': ['Usual Treatment (Control)']}, {'name': 'Group Metacognitive Therapy (Group-MCT): Experimental', 'type': 'BEHAVIORAL', 'description': 'Group metacognitive therapy (Group-MCT) focuses on developing adaptive control of worry, repetitive negative thinking and attention and modifies beliefs that maintain unhelpful thinking patterns. Treatment is 6 to 8 weekly sessions delivered by two trained mental health professionals, guided by a treatment manual, lasting approximately 90 minutes each session.', 'armGroupLabels': ['Group MCT (Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Adrian Wells', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}, {'name': 'Greater Manchester Mental Health NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical and Experimental Psychopathology', 'investigatorFullName': 'Adrian Wells', 'investigatorAffiliation': 'University of Manchester'}}}}