Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02479594
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Competence-feedback and Therapy Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory II (BDI II)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'self-report measure to assess depressive symptoms'}], 'secondaryOutcomes': [{'measure': 'Hamilton Depression Scale (HAMD-17)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'external assessment to assess depressive symptoms'}, {'measure': 'Inventory of Interpersonal Problems (IIP-C)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': "self-report instrument to identify a person's salient interpersonal difficulties based on the interpersonal circumplex model"}, {'measure': 'Health-related quality of life (SF-12)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'self-report measure to assess health-related quality of life'}, {'measure': 'Client Satisfaction Questionaire (CSQ8)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'self-report measure to assess satisfaction with therapy'}, {'measure': 'Cognitive Therapy Scale (CTS)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'external-assessment measure that assesses psychotherapeutic competency during a cognitive therapy session. CTS will be used by two trained raters licensed as psychological psychotherapists'}, {'measure': 'Helping Alliance Questionaire (HAQ)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'self-report measure to assess therapeutic alliance from the therapists perspective (therapist version; HAQ-T), the patients perspective (HAQ-P) and the raters perspective (HAQ-R)'}, {'measure': 'Assessment of Patient Interpersonal Behavior (AFPIB)', 'timeFrame': 'participants will be followed for the duration of psychotherapy, an expected average of 20 weeks', 'description': 'assessment of patient in-session interpersonal behavior'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['competence-feedback'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '40884452', 'type': 'DERIVED', 'citation': "Maass U, Witthoft M, Junga YM, Hahn D, Weck F. Relationships Among Patients' Interpersonal Behaviors in Sessions, Therapist Competence, and the Therapeutic Alliance in Cognitive Behavior Therapy: A Cross-Lagged Panel Analysis. J Clin Psychol. 2025 Aug 30. doi: 10.1002/jclp.70040. Online ahead of print."}, {'pmid': '34881909', 'type': 'DERIVED', 'citation': 'Weck F, Junga YM, Kliegl R, Hahn D, Brucker K, Witthoft M. Effects of competence feedback on therapist competence and patient outcome: A randomized controlled trial. J Consult Clin Psychol. 2021 Nov;89(11):885-897. doi: 10.1037/ccp0000686.'}]}, 'descriptionModule': {'briefSummary': 'In a randomized controlled study design, n = 58 treatments of patients with depression were to be conducted under a feedback-condition, in which the therapist would receive feedback five times within 20 treatment sessions. The competence-feedback includes detailed feedback about 14 different aspects of therapist behavior. The control group includes n = 58 further treatments within which therapists do not receive any competence-feedback (treatment as usual; TAU).', 'detailedDescription': "Psychotherapeutic competencies are considered to be an important factor for therapy success. However, empirical studies which have investigated the competence-outcome relationship were only based on correlational analyses. Therefore, these studies are inappropriate for the investigation of causal relationships. In previous studies, feedback on therapists' competencies was found to be suitable for enhancing such competencies. Therefore, in the current research project, competence-feedback should be used to enhance therapeutic competencies systematically, in order to investigate the causal impact of these competencies on therapy outcome. Using a randomized controlled study design, n = 58 treatments of patients with depression were to be conducted under a feedback-condition, in which the therapist would receive feedback five times within 20 treatment sessions. The competence-feedback includes detailed feedback about 14 different aspects of therapist behavior. The control group includes n = 58 further treatments within which therapists do not receive any competence-feedback (treatment as usual; TAU). In order to ensure comparability of both treatment conditions (regarding an observation situation), the therapists in the TAU condition should also receive feedback, but only after the treatments are finished. We hypothesize that the feedback-group is superior to the TAU-group and that their treatments lead to significantly better therapy outcome. Moreover, we use mediator analysis to analyze whether the group-outcome relationship is mediated by therapeutic competencies or by the quality of the therapeutic alliance. The results are highly relevant for clinical process research, psychotherapy training and for the dissemination of treatment approaches in routine care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'THERAPISTS\n\nInclusion Criteria:\n\n* Having successfully completed the interim Audit\n* Having started to treat ambulant patients\n\nExclusion Criteria:\n\n\\---\n\nPATIENTS\n\nInclusion Criteria:\n\n* Clinical diagnosis of Major Depression (Meeting DSM-IV criteria)\n* Informed consent\n\nExclusion Criteria:\n\n* Suicidal tendency\n* Clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder\n* Clinical diagnosis of personality disorder cluster A (odd disorders) and B (dramatic, emotional or erratic)'}, 'identificationModule': {'nctId': 'NCT02479594', 'briefTitle': 'Competence-feedback and Therapy Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'The Importance of Competence-feedback for Therapy Outcome: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'WE_01'}, 'secondaryIdInfos': [{'id': 'WE 4652/7-1', 'type': 'OTHER_GRANT', 'domain': 'German Research foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'competence-feedback', 'description': 'Therapists assigned to this group will receive standardized feedback on their psychotherapeutic competency after every fourth treatment session with a patient for a period of 20 therapy sessions. The feedback will be given by two experienced raters who are licensed as psychological psychotherapists.', 'interventionNames': ['Behavioral: competence-feedback']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Therapists assigned to this group will receive no competence-feedback.', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'competence-feedback', 'type': 'BEHAVIORAL', 'description': 'competence-feedback', 'armGroupLabels': ['competence-feedback']}, {'name': 'control', 'type': 'OTHER', 'description': 'control group without competence-feedback', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55122', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Florian Weck, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Potsdam'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Potsdam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of studies', 'investigatorFullName': 'Florian Weck', 'investigatorAffiliation': 'University of Potsdam'}}}}