Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-25 @ 2:39 AM
Study NCT ID:
NCT04321759
Status:
RECRUITING
Last Update Posted:
2023-11-14
First Post:
2020-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D066107', 'term': 'Social Skills'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized cluster design with 19 service centers assigned to one of the two treatments.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 378}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Social Adjustment Scale II', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Measure of social functioning'}, {'measure': 'Change in Heinrich Quality of Life Scale', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Measure of social functioning'}, {'measure': 'Change in Social Skills Performance Assessment', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Measure of social functioning using role played scenarios'}], 'secondaryOutcomes': [{'measure': 'Change in Auditory Verbal Learning Test', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of verbal ability in NIH Toolbox'}, {'measure': 'Change in List Sorting Working Memory', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of working memory in NIH Toolbox'}, {'measure': 'Change in Positive and Negative Syndrome Scale, PANSS-6', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Short form of measure of positive and negative symptoms'}, {'measure': 'Change in Picture Sequence Memory', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of visual/episodic memory \\& learning in NIH Toolbox'}, {'measure': 'Change in Picture Vocabulary', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of language in NIH Toolbox'}, {'measure': 'Change in Oral Reading Recognition', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of language in NIH Toolbox'}, {'measure': 'Change in Penn Mouse Practice Test', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of speed of processing in PennCNB'}, {'measure': 'Change in Penn Digit Symbol Test', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of speed of processing in PennCNB'}, {'measure': 'Change in Penn Conditional Exclusion Test', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of reasoning \\& problem solving in PennCNB'}, {'measure': 'Change in Penn Continuous Performance Test', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Neurocognition measure of reasoning \\& problem solving in PennCNB'}, {'measure': 'Change in Managing Emotions', 'timeFrame': 'Measurement at 0, 6, 12, 18, 24 months', 'description': 'Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive functioning', 'Social skills', 'Community functioning'], 'conditions': ['Schizophrenia and Related Disorders']}, 'referencesModule': {'references': [{'pmid': '36050663', 'type': 'RESULT', 'citation': 'Schutt RK, Xie H, Mueser KT, Killam MA, Delman J, Eack SM, Mesholam-Gately R, Pratt SI, Sandoval L, Santos MM, Golden LR, Keshavan MS. Cognitive Enhancement Therapy vs social skills training in schizophrenia: a cluster randomized comparative effectiveness evaluation. BMC Psychiatry. 2022 Sep 1;22(1):583. doi: 10.1186/s12888-022-04149-x.'}], 'seeAlsoLinks': [{'url': 'https://bmcpsychiatry.biomedcentral.com/counter/pdf/10.1186/s12888-022-04149-x.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.', 'detailedDescription': 'Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18 to 65;\n2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview);\n3. estimated IQ of \\> 70 (established via WTAR).\n\nExclusion Criteria:\n\n1. the presence of a current organic brain syndrome;\n2. intellectual disability (DSM-5);\n3. participation in either CET or SST within the prior year.'}, 'identificationModule': {'nctId': 'NCT04321759', 'briefTitle': 'Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Comparative Effectiveness of Cognitive Enhancement Therapy vs. Social Skills Training in Serious Mental Illness', 'orgStudyIdInfo': {'id': '2020P000094'}, 'secondaryIdInfos': [{'id': 'CER-2018C3-14701', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Enhancement Therapy', 'description': 'CET is a comprehensive manualized cognitive remediation program designed to maximize gains in social functioning by integrating computer-based training to enhance neurocognition with group-based exercises to improve social cognition.', 'interventionNames': ['Behavioral: Cognitive Enhancement Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Social Skills Training', 'description': 'The HOPES social rehabilitation program uses the principles of SST (modeling, role playing, positive and corrective feedback, homework assignments, in vivo skills practice), designed to improve both psychosocial functioning and preventive health..', 'interventionNames': ['Behavioral: Social Skills Training']}], 'interventions': [{'name': 'Cognitive Enhancement Therapy', 'type': 'BEHAVIORAL', 'description': "CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.", 'armGroupLabels': ['Cognitive Enhancement Therapy']}, {'name': 'Social Skills Training', 'type': 'BEHAVIORAL', 'otherNames': ['HOPES'], 'description': 'The psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.', 'armGroupLabels': ['Social Skills Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jimmy Choi, PsyD', 'role': 'CONTACT'}], 'facility': 'Hartford Hospital - Institute of Living', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristen Woodberry, MSW, PhD', 'role': 'CONTACT'}], 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Fred Crow, MD', 'role': 'CONTACT'}], 'facility': 'Massachusetts Mental Health Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01603', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Xaioduo Fan, MD, MPH', 'role': 'CONTACT'}], 'facility': 'UMass Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'centralContacts': [{'name': 'Jennifer Sabbagh', 'role': 'CONTACT', 'email': 'jsabbagh@bidmc.harvard.edu', 'phone': '617-975-8545', 'phoneExt': '58545'}, {'name': 'Blanche Spindell', 'role': 'CONTACT', 'email': 'bspindel@bidmc.harvard.edu', 'phone': '617-735-4261'}], 'overallOfficials': [{'name': 'Matcheri S Keshavan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'Russell K Schutt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Stanley Cobb Professor and Academic Head of Psychiatry, Department of Psychiatry,', 'investigatorFullName': 'Matcheri S. Keshavan MD', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}