Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-03 @ 11:44 PM
Study NCT ID:
NCT03453957
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Alliance Tensions and Repair in Psychotherapy Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participating therapists will be aware of their group (Professional development training vs no training control); however, their participating patient/clients will not know which experimental group their therapists belongs to.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a 2-arm, parallel, prospective, single-blind cluster RCT with 1-1 allocation comparing: (a) therapists who receive the professional development intervention to identify and repair alliance tensions at the study outset versus (b) therapists who receive the intervention after participation is complete (no training control). Therapists will be randomized to study condition and patients will be clustered within therapists. Randomization will control for: (a) the effect of therapist variables (age, gender, theoretical orientation, experience, differing initial skill level) on competence, therapeutic alliance, or patient outcomes; (b) potential biases caused by pre-treatment patient variables (symptom severity, co-morbidity, chronicity, psychoactive medications); and (c) treatment or study factors (e.g. frequency of sessions, time to complete the study sessions, treatment received after the study sessions). Patients will be blind to therapist study arm allocation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean tension resolution rating scale', 'timeFrame': '6 therapy sessions over 6 weeks up to 6 months depending on the frequency of therapy', 'description': 'The Rupture Resolution Rating System (3RS) is an observer-based measure to identify alliance tensions and resolution processes. Independent blind reliable trained judges will rate video recordings of 6 psychotherapy session recorded with participating clients. A mean tension score will be assigned per client which will be the average of the 6 session scores.\n\nscore ranges from 1 (withdrawal/confrontation rupture(s) did not occur; not significant for the alliance) to 5 (withdrawal/confrontation rupture(s) occurred; significant for the alliance).'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder 7-item scale (GAD-7) change from baseline', 'timeFrame': 'baseline and end of 6 therapy sessions, 6 weeks to 6 months depending on the frequency of therapy', 'description': 'Self-report measurement of severity of anxiety using the GAD-7 scale. A change in anxiety scores will be assess following 6 therapy session with data collected before therapy(baseline) and again after all 6 sessions of therapy have been completed. Scores range from 0 (low anxiety) to 27 (high anxiety) with scores over 10 being of clinical significance.'}, {'measure': 'Patient Health Questionnaire 9-item scale (PHQ-9) change from baseline', 'timeFrame': 'baseline and end of 6 therapy sessions, 6 weeks to 6 months depending on the frequency of therapy', 'description': 'Self-report measurement of depression symptoms using the PHQ-9 scale. A change in depression symptom scores will be assess following 6 therapy session with data collected before therapy and again after all 6 sessions of therapy have been completed. Scores range from 0 (low) to 27 (high) with scores over 10 being of clinical significance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Practice based research'], 'conditions': ['Psychotherapy', 'Therapeutic Alliance']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.pprnet.ca', 'label': 'PPRNet website including study-related information and publications'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a professional development program intended to improve the relationship or alliance between therapists and patients/clients who are receiving psychotherapy in the community. Half of the participating therapists will receive training to detect and improve alliance with new patients while half will not. The professional development training is expected to improve therapists effectiveness in identifying and correcting alliance tensions which will, in turn, improve therapeutic outcomes for patients/clients.', 'detailedDescription': "Psychotherapy is the treatment of choice for many mental disorders, yet there is a gap between research and practice. Research indicates that: the therapist-patient alliance is important to reduce patient symptoms, alliance tensions are detrimental to patients, and those therapists who identify and repair alliance tensions can improve patient outcomes. In this study we will use state of the art research to train community-based therapists in evidence-based interventions to identify and repair alliance tensions. Trained therapists and their patients will be compared to therapists who provide usual care to their patients. Improvement in therapists' skills in identifying and repairing alliance tensions and how this is associated with better patient mental health outcomes will be measured. Trained therapists will be interviewed to identify the best ways of improving the training and disseminating the findings to psychotherapists across Canada. Research to improve practicing therapists' ability to identify and repair therapeutic alliance tensions will result in better mental health outcomes for patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Therapist\n\nInclusion Criteria:\n\n* regulated health professional\n* in good standing with a Canadian provincial regulatory college\n* scope of practice includes psychotherapy\n* ability to add 3 or more new, English speaking clients to caseload over 6 to 9 months\n* ability to obtain timely permission to conduct research from therapist's employing institution or health group when applicable\n\nExclusion Criteria:\n\n* none\n\nPatient/Client\n\nInclusion Criteria:\n\n* 18 years of age or older\n* will participate in psychotherapy sessions in English\n* will see the study-affiliated therapist for a minimum of 6 sessions in the next 6 months\n\nExclusion Criteria:\n\n* already seeing another therapist\n* diagnosed with a neurocognitive disorder\n* diagnosed with a psychotic disorder\n* expressed suicidal behaviour in the past six months as assessed by their participating therapist"}, 'identificationModule': {'nctId': 'NCT03453957', 'briefTitle': 'Therapeutic Alliance Tensions and Repair in Psychotherapy Practices', 'organization': {'class': 'OTHER', 'fullName': 'University of Ottawa'}, 'officialTitle': 'Therapeutic Alliance Tensions and Repair in Psychotherapy Practices: A Psychotherapy Practice Research Network (PPRNet) Study', 'orgStudyIdInfo': {'id': '363733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Professional Development Program', 'description': 'Therapists who participate in workshops and consultation sessions with study trainers during study-related therapy sessions and their participating patients/clients.', 'interventionNames': ['Other: Professional development program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Therapists who did not participate in workshops and consultations sessions while engaging in study-related therapy sessions and their participating patients/clients.'}], 'interventions': [{'name': 'Professional development program', 'type': 'OTHER', 'description': 'Professional development program consists of training including workshops and consultation sessions to enhance therapists ability to detect and repair alliance ruptures in active community based psychotherapy.', 'armGroupLabels': ['Professional Development Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1N 6N5', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Giorgio Tasca, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ottawa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Giorgio A. Tasca', 'investigatorAffiliation': 'University of Ottawa'}}}}