Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT02095457
Status:
UNKNOWN
Last Update Posted:
2014-03-24
First Post:
2014-03-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Routine Outcome Monitoring in Mental Health Outpatient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D010554', 'term': 'Personality Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-20', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall clinical well-being as measured by the CORE-OM rating scale', 'timeFrame': 'up to 3 years follow-up', 'description': 'The CORE-OM is a short questionnaire that addresses broad psychiatric symptoms including depression, anxiety, well-being, vocational and domestic functioning, social problems, etc.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization rates', 'timeFrame': 'up to three years of follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Routine Outcome Monitoring', 'Psychotherapy', 'Alliance', 'Feedback Informed Treatment', 'Mental Health Outpatients'], 'conditions': ['Affective Disorders', 'Anxiety Disorders', 'Psychotic Disorders', 'Personality Disorders']}, 'descriptionModule': {'briefSummary': 'Scientific Background: Inherent gaps exist between the worlds of research and clinical therapy, especially in mental-health systems. Developed as an important strategy aimed to bridge them, widening efforts worldwide have implemented Routine Outcome Monitoring (ROM), a method devised for systematic ongoing quantitative measurements used in diverse clinical practices, from psychotherapies to psychiatric management. The efficacy of this approach has been repeatedly demonstrated in various measures, such as satisfaction with treatment by patients and therapists, lower drop-out rates, symptomatic benefits, and more.\n\nObjectives: The aim of the current study is to test the feasibility and the clinical benefits of implementation of a Routine Outcome Monitoring System in a public clinical center, as a pioneering project in Israel, at the "Shalvata" Mental Health Center.\n\nWorking Hypotheses: Incorporation of a ROM system in routine clinical practice is hypothesized to improve patients\' and therapists\' overall satisfaction, allow for early detection and intervention in therapeutic raptures, decrease drop-out rates, and improve various clinical outcome measures.\n\nMethods: The suggested study is a two-stage (implementation and intervention) open trial. 900 new outpatients in \'Shalvata\' clinics will be recruited and randomized to intervention (ROM) and control groups. Assessment questionnaires will be filled periodically using \'CORE-NET\', a computerized system enabling repeated measurements and feedback in a user-friendly and efficient manner.\n\nData Analysis: The evaluation of the differential influence of monitoring processes on overall efficiency as compared to control group will be tested using Multiple Analysis of Variance (MANOVA). The predictive value of possible variables on process and outcome of therapy will be assessed using stratified regression analyses. The possible causal effects between specific lagged variables will be assessed using Hierarchical Linear Modeling and Time Series Analysis.\n\nContribution: This pioneering study is the first in Israel to offer a routine systematic evaluation of therapeutic processes, as well as assessing its clinical effects. Consequently, a large and meaningful data-set will emerge, enabling significant enrichment of our evidence-based understanding of therapeutic processes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing intake to the clinic and beginning therapy\n\nExclusion Criteria:\n\n* Mental retardation or dementia\n* Hebrew Illiteracy\n* Adults who are not under their own legal custody\n* Not being able to fulfill the questionnaires with minor help'}, 'identificationModule': {'nctId': 'NCT02095457', 'acronym': 'ROM-Shalvata', 'briefTitle': 'Routine Outcome Monitoring in Mental Health Outpatient', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'officialTitle': 'A Randomized Trial of Routine Computerized Outcome and Process Clinical Measures Monitoring in Mental Health Outpatient Services: Preparing for the Planned Public Mental Health Reform in Israel', 'orgStudyIdInfo': {'id': 'NIHP-R-161-2013'}, 'secondaryIdInfos': [{'id': 'R-161-2013', 'type': 'OTHER_GRANT', 'domain': 'The Israel National Institute for Health Policy Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Frequent Monitoring and Feedback', 'description': 'In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy', 'interventionNames': ['Behavioral: Frequent monitoring and feedback']}, {'type': 'SHAM_COMPARATOR', 'label': 'Infrequent monitoring without feedback', 'description': 'In the control arm, patients will infrequently fill short monitoring questionnaires, the results of which are not fed back to their therapists and staff. The frequency of monitoring is between about once a year', 'interventionNames': ['Behavioral: Frequent monitoring and feedback']}], 'interventions': [{'name': 'Frequent monitoring and feedback', 'type': 'BEHAVIORAL', 'description': 'In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy', 'armGroupLabels': ['Frequent Monitoring and Feedback', 'Infrequent monitoring without feedback']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'country': 'Israel', 'contacts': [{'name': 'Lior Biran, Clinical Psychologist', 'role': 'CONTACT', 'email': 'liorbiran@gmail.com, liorbi@clalit.org.il', 'phone': '972-54-4708886'}, {'name': 'Lior Biran', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ori Ganor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shalvata Mental Health Center Outpatient clinics', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'centralContacts': [{'name': 'Ori Ganor, MD', 'role': 'CONTACT', 'email': 'origa1@clalit.org.il', 'phone': '972-54-5454886'}, {'name': 'Lior Biran, Clinical Psychologist', 'role': 'CONTACT', 'email': 'liorbiran@gmail.com, liorbi@clalit.org.il', 'phone': '972-54-4708886'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ori Ganor, MD', 'investigatorFullName': 'Ori Ganor', 'investigatorAffiliation': 'Shalvata Mental Health Center'}}}}