Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-30 @ 8:31 AM
Study NCT ID:
NCT05851950
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RUFUS - Group Rumination-focused CBT for Negative Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Brief Negative Symptoms Scale (BNSS)', 'timeFrame': 'up to 20 weeks', 'description': 'Assessment of negative symptoms on a scale from 0-78'}], 'secondaryOutcomes': [{'measure': 'Perseverative Thinking Questionnaire (PTQ)', 'timeFrame': 'up to 20 weeks', 'description': 'Measuring frequency of rumination. Resulting in a total score of 0-60.'}, {'measure': 'Ruminative Response Scale (RRS)', 'timeFrame': 'up to 20 weeks', 'description': 'Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.'}, {'measure': 'Social Functioning Scale (SFS)', 'timeFrame': 'up to 20 weeks', 'description': 'Measuring level of functioning on a scale from of 0-228'}, {'measure': 'Scale for the assessment of positive symptoms (SAPS)', 'timeFrame': 'up to 20 weeks', 'description': 'Measuring presence of positive symptoms on a scale from 0-170'}, {'measure': 'Calgary depression scale (CDS)', 'timeFrame': 'up to 20 weeks', 'description': 'Measuring depressive symptoms on a scale from 0-27'}, {'measure': 'Behavior Rating Inventory of Executive Function (BRIEF)', 'timeFrame': 'up to 20 weeks', 'description': 'Measuring executive functioning on a scale from 75-225'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychotic Disorders']}, 'descriptionModule': {'briefSummary': "Abstract - --\n\nIntroduction:\n\nPsychosis spectrum disorders are characterized by both positive and negative symptoms, but whereas there is good effect of treatment on positive symptoms, there is still a scarcity of effective interventions aimed at reducing negative symptoms. Rumination has been proposed as an important and fundamental factor in the development and maintenance of symptoms across psychiatric diagnoses, and there is a need to develop effective interventions targeting rumination behaviors and negative symptoms in patients with psychotic disorders. The aim of the current study is to investigate the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (RFCBT) in the treatment of young people with psychosis spectrum disorders as well as investigating potential indications of treatment efficacy.\n\nMethods and analysis: The study is a mixed-method clinical randomized controlled pilot trial with a target sample of 60 patients, who are randomized to either receive 13 weeks of group CFCBT or 13 weeks of treatment as usual (TAU). All patients are examined at the start of the project and at the 13-week follow-up. The researcher will compare changes in outcomes from baseline to posttreatment between group CFCBT and TAU. In addition, qualitative analyzes are carried out to explore feasibility and acceptability and to uncover the patients' experience of receiving the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with a psychosis spectrum disorder (ICD-10 F2x)\n2. At least 8 months left of their OPUS treatment\n3. The presence of rumination behavior as assessed by a score of minimum 30 on the Perseverative Thinking Questionnaire (PTQ)\n4. Danish-speaking\n\nExclusion Criteria:\n\n1. Substance abuse or positive symptoms that make participation in therapy difficult\n2. Severe suicidal thoughts/behavior\n3. Lacks capacity to consent\n4. Mild, moderate, or severe intellectual disability (IQ ˂ 70)\n5. Planned adjustment of antidepressant and/or antipsychotic treatment (noted in the patient's medical record)"}, 'identificationModule': {'nctId': 'NCT05851950', 'acronym': 'RUFUS', 'briefTitle': 'RUFUS - Group Rumination-focused CBT for Negative Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'RUFUS - a Randomized Mixed Methods Pilot Clinical Trial Investigating the Relevance and Feasibility of Rumination-focused Cognitive Behavioral Therapy in the Treatment of Patients With Emergent Psychosis Spectrum Disorder', 'orgStudyIdInfo': {'id': '05851950'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rumination-focused cognitive behavioural group therapy', 'description': '1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session.', 'interventionNames': ['Other: group rumination focused cognitive behavioural therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'standard OPUS treatment. OPUS treatment is handled by an interdisciplinary OPUS team and consists primarily of medical treatment, psychoeducation, training in symptom management and social skills as well as family discussions. All patients in OPUS have a contact doctor and a contact person who is responsible for coordinating the treatment and collaborating with municipal bodies.', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'group rumination focused cognitive behavioural therapy', 'type': 'OTHER', 'description': 'Psychotherapy', 'armGroupLabels': ['rumination-focused cognitive behavioural group therapy']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'opus treatment', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christin Lund', 'role': 'CONTACT', 'email': 'christin.louise.nymann.lund@regionh.dk'}], 'facility': 'Mental Health Centre Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Lars Clemmensen', 'role': 'CONTACT', 'email': 'lars.clemmensen@regionh.dk', 'phone': '23492490'}], 'overallOfficials': [{'name': 'Louise B Glenthøj', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental health center of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}