Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT05018312
Status:
UNKNOWN
Last Update Posted:
2023-03-28
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D010554', 'term': 'Personality Disorders'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking will be applied in the data analysis process'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Naturalistic, superiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rosenberg Self-Esteem Scale (RSES)', 'timeFrame': 'Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)', 'description': 'The RSES is a 10-item measure of self-esteem that includes five positive items and five negative items which are reversed scored (Rosenberg, 1965). In general, the RSES has demonstrated good convergent validity and good test-retest reliability and in similar populations of adults with social phobia, the RSES has demonstrated high internal consistency.\n\nThe minimum score is 10 and maximum value is 40. A higher score indicate that the patient has a better self-esteem, compared to a lower.'}, {'measure': 'General Self-Efficacy Scale (GSES)', 'timeFrame': 'Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)', 'description': "The GSE is a 10-item psychometric scale that is designed to a ssess optimistic self-beliefs to cope with a variety of difficult demands in life. In contrast to other scales that were designed to assess optimism, this one explicitly refers to personal agency, i.e., the belief that one's actions are responsible for successful outcomes.\n\nThe minimum score is 10 and maximum value is 40. A higher score indicate that the patient feels better suited to handle difficult situations, compared to a lower."}, {'measure': 'Working Alliance Inventory (WAI)', 'timeFrame': 'T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)', 'description': "The WAI is a 12-item psychometric questionnaire that is designed to assess the therapeutic alliance between a patient and a therapist.\n\nThe questionaire isn't scored."}, {'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)', 'description': 'The CSQ-8 is a self-report questionnaires constructed to measure satisfaction with services received by individuals and families.\n\nThe minimum score is 8 and maximum value is 32. A higher score indicate that the patient is more satisfied with the treatment, compared to a lower.'}, {'measure': 'National Patient Reported Outcome Measures (PROM)- Psychiatry', 'timeFrame': 'Baseline T0 (end of intervention, an average of four weeks after allocation); T1 (end of intervention) and T2 (after one month psychotherapy)', 'description': 'The Danish National PROM is a 19-item, self-report measure covering patients own view on their mental and physical health, and level of general well-being.\n\nThe minimum score is 19 and maximum value is 114. A higher score indicate that the patient is less burdened by his/her symptoms, compared to a lower.'}, {'measure': 'Purpose-made questionary on specific feasibility-outcomes', 'timeFrame': 'T1 (end of intervention, an average of four weeks after allocation)', 'description': "We intend to - for the purpose of this trial - construct questionnaires evaluating the patients' and clinicians´ evaluation of the intervention."}, {'measure': 'Readiness for Psychotherapy Index', 'timeFrame': 'Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)', 'description': 'The RPI is a 20-item self-report measure that uses a 5-point Likert scale to assess 7 dimensions of readiness for psychotherapy: level of distress, desire for change, willingness to work in therapy, recognition of problems as psychological, willingness to discuss personal matters, willingness to endure discomfort in therapy, and responsibility for change. The questionnaire will be translated and validated for use in a Danish mental health service population.\n\nThe minimum score is 20 and maximum value is 100. A higher score indicate that the patient is less ready to participate in psychotherapy, compared to a lower.'}], 'primaryOutcomes': [{'measure': 'University of Rhode Island Change Assessment Scale (URICA)', 'timeFrame': 'Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)', 'description': 'The URICA is a 32-item self-report measure that includes 4 subscales measuring the motivation for change: Precontemplation, Contemplation, Action, and Maintenance. The minimum score is 32 and maximum value is 160. A higher score indicate that the patient is more ready to making changes in their life, compared to a lower.'}], 'secondaryOutcomes': [{'measure': 'Liebowitz Social Anxiety Scale-Self- Report (LSAS)', 'timeFrame': 'Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy)', 'description': 'The 24-item LSAS-SR, includes questions pertaining to social interaction and performance situations. The LSAS-SR have shown to have good convergent, discriminant validity, and reliability. The minimum score is 48 and maximum value is 144. A higher score indicate that the patient have greater problems with anxiety, compared to a lower.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Therapeutic Assessment', 'Psychiatry', 'Person-centered', 'Mental Health Service', 'Pre-therapy', 'Collaborative Assessment'], 'conditions': ['Psychotherapy', 'Social Anxiety Disorder', 'Personality Disorders']}, 'referencesModule': {'references': [{'pmid': '39456051', 'type': 'DERIVED', 'citation': "Hovmand OR, Reinholt N, Dichmann K, Borisov R, Hjorthoj C, Arnfred S. Results of a randomized controlled superiority trial of the effect of modified collaborative assessment vs. standard assessment on patients' readiness for psychotherapy (CO-ASSM-RCT). Trials. 2024 Oct 25;25(1):716. doi: 10.1186/s13063-024-08517-8."}]}, 'descriptionModule': {'briefSummary': 'The present study wish to compare the preliminarily effects and feasibility of Modified Collaborative Assessment (MCA) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.', 'detailedDescription': 'The present study wish to compare the preliminarily effects and feasibility of Modified Collaborative Assessment (MCA) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual (AAU) among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.\n\nThe study will include and randomise 42 patients 1:1 to either MCA or AAU, which will be administered as a pre-treatment to the standard psychotherapeutic intervention they will receive in the psychotherapeutic clinic.\n\nMCA will utilize standardised psychological tests administered in collaboration with the patients, in order to thorough diagnose the included patients. The tests available will be the Present State Examination (PSE), the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD), the Screen for Cognitive Impairment in Psychiatry (SCIP), the Autism Diagnostic Observation Schedule (ADOS-2), the Examination of anomalous self-experience (EASE), the Wechsler Adult Intelligence Scale (WAIS-IV), the Level of Personality Functioning - Brief Form 2.0 (LPFS-BF), the Personality Inventory for DSM-5, 36 item version (PID-36) and the Conners´ Adult ADHD Rating Scales (CAARS).\n\nData are gathered through a number of questionnaires from patients prior to randomization (T0), at end of MCA (T1) and after four weeks of psychotherapy (T2) - absolute time depend on clinical logistics and timing of group therapy onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A tentative ICD-10 diagnosis of either SAD or EPD\n* Going to be offered treatment in the psychiatric community clinics in Naestved, Maribo or Slagelse\n\nExclusion Criteria:\n\n* Severe physical health problems.\n* Lack of spoken and written danish corresponding to 9th grade primary school.\n* Eating disorder with BMI \\< 18\n* Psychotic illness\n* Active diagnosis of substance abuse'}, 'identificationModule': {'nctId': 'NCT05018312', 'acronym': 'CO-ASSM-RCT', 'briefTitle': 'Modified Collaborative Assessment VS Standard Assessment on Readiness For Psychotherapy Among Patients With Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Psychiatric Research Unit, Region Zealand, Denmark'}, 'officialTitle': "Social Phobia and Evasiveness: A Feasibility, Superiority, Randomized Clinical Trial of the Effect of Modified Collaborative Assessment VS Standard Assessment on Patient's Readiness For Psychotherapy (CO-ASSM-RCT)", 'orgStudyIdInfo': {'id': '2021001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Collaborative Assessment (MCA)', 'description': 'The patients allocated to this arm will receive assessment inspired by therapeutic/collaborative assessment, as a pre-treatment to the standard psychotherapeutic treatment they will receive in the clinic.', 'interventionNames': ['Behavioral: Modified Collaborative Assessment (MCA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Assessment as usual (AAU)', 'description': 'The patients allocated to this arm will receive standard assessment offered in the clinic, before proceeding to the standard psychotherapeutic treatment they will receive in the clinic.', 'interventionNames': ['Behavioral: Assessment as Usual (AAU)']}], 'interventions': [{'name': 'Modified Collaborative Assessment (MCA)', 'type': 'BEHAVIORAL', 'description': 'The Modified Collaborative Assessment (MCA) will be assessment of the patients that Is more thoroughly-done, and which will be inspired by the school of Therapeutic Assessment and Collaborative Assessment. It will include the EASE, SCID-interview, PSE, ADOS and SCIP-interviews.', 'armGroupLabels': ['Modified Collaborative Assessment (MCA)']}, {'name': 'Assessment as Usual (AAU)', 'type': 'BEHAVIORAL', 'description': 'Assessment as usual is the standard assessment the patients will receive in the clinic. It includes one or more interviews with a mental health professional in the clinic.', 'armGroupLabels': ['Assessment as usual (AAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4930', 'city': 'Maribo', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Psykiatrisk Klinik Maribo', 'geoPoint': {'lat': 54.77662, 'lon': 11.50017}}, {'zip': '4700', 'city': 'Næstved', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Psykiatrisk Klinik Næstved', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}], 'overallOfficials': [{'name': 'Sidse Arnfred, MD PhD DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand MHS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psychiatric Research Unit, Region Zealand, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Unit for Psychotherapy and Psychopathology, Psychiatry West, Region Zealand Mental Health Service', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, senior consultant, MD MSc PHD DMSC', 'investigatorFullName': 'Sidse Arnfred', 'investigatorAffiliation': 'Psychiatric Research Unit, Region Zealand, Denmark'}}}}