Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:21 AM
Study NCT ID:
NCT07488559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study 2: Social Engage Coaching R33 Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loneliness', 'timeFrame': '8-week follow-up', 'description': 'PROMIS Social Isolation Short Form 4a assessed by Ecological Momentary Assessment (EMA) for 10 days.'}, {'measure': 'Belonging', 'timeFrame': '8-week follow-up', 'description': 'Interpersonal Needs Questionnaire assessed by Ecological Momentary Assessment (EMA) for 10 days.'}, {'measure': 'Time in conversations', 'timeFrame': '8-week follow-up', 'description': 'Self-report of frequency of conversations with others assessed by Ecological Momentary Assessment (EMA) for 10 days.'}, {'measure': 'Time outside the home', 'timeFrame': '8-week follow-up', 'description': 'Self-report of frequency of time outside the home assessed by Ecological Momentary Assessment (EMA) for 10 days.'}], 'secondaryOutcomes': [{'measure': 'Suicide ideation', 'timeFrame': '16-week follow-up', 'description': 'Geriatric Suicide Ideation Scale Screening version that provides a continuous score of severity of suicide ideation with four items, assessed by Ecological Momentary Assessment (EMA) for 10 days.'}, {'measure': 'Depression', 'timeFrame': '16-week follow-up', 'description': 'PROMIS Depression Short Form assessed by Ecological Momentary Assessment (EMA) for 10 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loneliness', 'Older adults', 'Ecological momentary assessment', 'Engage Psychotherapy', 'Late-life suicide'], 'conditions': ['Social Connection', 'Loneliness', 'Suicide Ideation', 'Social-emotional Quality of Life']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.', 'detailedDescription': 'The R33 phase is an RCT (S-ENG+eCAU vs. eCAU only; n=120) with follow-up at 8- and 16 weeks to test target engagement and clinical impact. 10 days of ecological momentary assessment (EMA) will be completed at all assessment points. Participants are 120 adults age 60 and older who report clinically significant loneliness and have access to social activities outside the home. EMA will comprehensively assess indices of social connection. Subjects will complete EMA daily following 3 personally-selected times for prompts (to enhance recall and ease of completion of assessments) for 10-days prior to starting study interventions, beginning the day after the baseline visit. Each EMA instance takes approximately 2-5 minutes to complete. Subjects who successfully complete the smartphone assessment protocol at baseline will be randomly assigned to coaching or waitlist control. Study conditions are Engage Coaching (10 individual coaching sessions) over (up to) 4 month or waitlist control (assessments only for 4 months and then coaching is offered). The follow-up assessments include baseline measures and EMA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Subjects are adults age 60 or older who have access to social activities, including through living in senior living communities, and who are at risk for suicide, including by endorsing clinically-significant loneliness over the prior month. Exclusion criteria are current problem drinking, psychosis, significant cognitive impairment, and hearing problems that preclude engagement with S-ENG and research assessors.'}, 'identificationModule': {'nctId': 'NCT07488559', 'briefTitle': 'Study 2: Social Engage Coaching R33 Phase', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'ENGAGE COACHING PROJECT R33', 'orgStudyIdInfo': {'id': 'STUDY00408657'}, 'secondaryIdInfos': [{'id': 'R33MH129476-03', 'link': 'https://reporter.nih.gov/quickSearch/R33MH129476-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Engage Coaching', 'description': 'Engage Coaching', 'interventionNames': ['Behavioral: Social Engage Coaching (S-ENG)']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'Study intervention (coaching) is provided after study completion (assessments)'}], 'interventions': [{'name': 'Social Engage Coaching (S-ENG)', 'type': 'BEHAVIORAL', 'description': "Social Engage Coaching (S-ENG) involves 10 individual coaching sessions focused on increasing social connection. S-ENG is a stepped, modular intervention that was developed to allow personalization to a given subject's needs, preferences, and individualized barriers to social connection. Early sessions include psychoeducation on the importance of social connection; a values clarification exercise on aspects of connection most important to subjects; and assessment of current social networks and social activities. Together, the coach and subject create a conceptualization of reasons for loneliness and identify personalized activities most likely to impact loneliness. The primary activity is 'action planning,' which involves selecting a social goal for the week, brainstorming ways to meet the goal, identifying barriers, and selecting specific actions to take before the next session. The first 8 sessions are offered weekly and the final two are monthly booster sessions.", 'armGroupLabels': ['Engage Coaching']}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/nda/access-data-info', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Data will be shared via the NIMH Data Archive in line with NIMH policies.', 'accessCriteria': 'Data will be accessible via the NIMH Data Archive.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kimberly Van Orden', 'investigatorAffiliation': 'University of Rochester'}}}}