Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-02 @ 7:39 AM
Study NCT ID:
NCT06749392
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Individual-specific Synchrony Signature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly change in Hamilton rating scale for depression (HRSD)', 'timeFrame': 'Measured at baseline and every week for 16 weeks of treatment', 'description': "A 17-item clinically administered measure assessing the severity of depression. Each item is rated on a scale ranging from 0 (don't have) to 4 (sever) or 0 (don't have) to 2 (sever). The total score ranges between 0 and 52, where higher scores indicate worse outcome."}], 'secondaryOutcomes': [{'measure': 'Weekly change in Beck Depression Inventory (BDI)', 'timeFrame': 'Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.', 'description': "A 21-item, self-rated scale that evaluates key symptoms of depression. Each item is rated on a scale ranging from 0 (don't have) to 3 (sever). The total score ranges between 0 and 63, where higher scores indicate worse outcome."}, {'measure': 'Weekly change in Outcome Questionnaire (OQ)', 'timeFrame': 'Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.', 'description': 'A 30 items self-report measure designed to assess patient therapy outcomes on three primary dimensions: (a) subjective discomfort, (b) interpersonal relationships, and (c) social role performance. Each item is rated on a scale ranging from 0 (never) to 4 (almost always). The total score ranges between 0 and 120, where higher scores indicate worse outcome.'}, {'measure': 'Trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)', 'timeFrame': 'Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.', 'description': 'A 16-item self report measure designed to assess quality of life enjoyment and satisfaction. Each item is rated on a scale ranging from 1 (not at all) to 5 (extremely). The total score ranges between 16 and 80, where higher scores indicate better outcome.'}, {'measure': 'Experiences in Close Relationships Questionnaire (ECR)', 'timeFrame': 'Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.', 'description': 'A 36-item self-report measure designed to assess adult attachment styles. The measurement data will be aggregated into two sub-scales: anxiety and avoidance. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score on each subscale ranges between 18 and 126, where higher scores indicate worse outcome.'}, {'measure': 'Trajectories of change in Inventory of Interpersonal Problems (IIP-32)', 'timeFrame': 'Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.', 'description': 'A 32-item self-report measure designed to assess interpersonal problems. Each item is rated in terms of how distressing the problem is for the individual on a scale ranging from 0 (not at all) to 4 (extremely). The total score ranges between 0 and 128, where higher scores indicate higher interpersonal problems, worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Synchrony', 'Therapeutic relationship', 'Trait-like', 'State-like', 'Multi-modal', 'Mechanisms of change'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '40481468', 'type': 'DERIVED', 'citation': 'Zilcha-Mano S, Bouknik Y, Malka M, Krasovsky T. An individual-specific understanding of how synchrony becomes curative: study protocol. BMC Psychiatry. 2025 Jun 6;25(1):587. doi: 10.1186/s12888-025-06539-3.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to establish synchrony as an individual-specific mechanism of therapeutic change and offers novel insights into the mechanisms of curative interpersonal processes. The study identifies individual-specific trait-like synchrony signature and investigates the associations between synchrony signature, the individual\'s trait-like characteristics, and mental health, among participants diagnosed with Major Depressive Disorder. The study further investigates how deterministic the trait-like synchrony signature is by identifying for whom, how, and when changes are anticipated. Additionally, it examines whether synchrony signature transfers to relationships with the therapist, whether and how it changes throughout treatment, and whether such potential changes are associated with improvements in mental health. Synchrony is recognized as a key driver of collaborative, affiliative, and curative relationships. While its potential role in improving mental health through interpersonal relationships has sparked growing interest, particularly in psychotherapy, the field is at a crossroads, with mixed findings challenging the widespread theoretical assumption that "more synchrony is better." This study introduces a personalized framework that emphasizes individual-specific synchrony signatures, shifting from generalized assumptions to tailored understanding and interventions. The study explores how synchrony can transform relationships into curative ones by leveraging individual-tailored changes in synchrony signatures in psychotherapy. The potential impact is vast. Tailoring synchrony to individual-specific signatures represents a paradigm shift from a one-size-fits-all approach to personalized interventions. This personalized framework could revolutionize mental health care by facilitating the development of targeted strategies that enhance treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5, and scores above 14 on the 17-item Hamilton rating scale for depression at two consecutive assessments, one week apart.\n* For participants using psychiatric medication, the dosage must be stable for at least three months before the beginning of the study, and they will be asked to maintain stable dosage during the treatment\n* Age between 18 and 65 years\n* Hebrew language proficiency\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Current risk of suicide or self-harm\n* Current substance abuse disorders\n* Current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring\n* History of organic mental disease\n* Currently in psychotherapy'}, 'identificationModule': {'nctId': 'NCT06749392', 'acronym': 'SynSig', 'briefTitle': 'An Individual-specific Synchrony Signature', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'An Individual-specific Understanding of How Synchrony Becomes Curative', 'orgStudyIdInfo': {'id': '101123661'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive-expressive psychotherapy', 'description': 'Participants will receive supportive-expressive therapy for depressive disorder for 16 weeks.', 'interventionNames': ['Behavioral: Supportive-expressive treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list', 'description': 'Participants will wait for treatment for 16 weeks. After the waiting the participants will receive in a supportive-expressive treatment for depressive disorder for 16 weeks.'}], 'interventions': [{'name': 'Supportive-expressive treatment', 'type': 'BEHAVIORAL', 'description': 'Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation. This treatment postulates insight as its core mechanism of change.', 'armGroupLabels': ['Supportive-expressive psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3498838', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sigal Zilcha Mano, Professor', 'role': 'CONTACT', 'email': 'sigalzil@gmail.com'}, {'name': 'Michal Malka, PhD', 'role': 'CONTACT', 'email': 'mi770543@gmail.com', 'phone': '0543363061'}], 'facility': 'University of Haifa', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Sigal Zilcha-Mano', 'role': 'CONTACT', 'email': 'sigalzil@gmail.com', 'phone': '972-8249047'}, {'name': 'Michal Malka', 'role': 'CONTACT', 'email': 'mi770543@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared due to ethical reasons.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Sigal Zilcha Mano', 'investigatorAffiliation': 'University of Haifa'}}}}