[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07655232":3,"trial-entities:NCT07655232":140,"trial-summary:NCT07655232":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":69,"sex":99,"minimum_age":100,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":101,"std_ages":114,"locations":117,"central_contacts":132,"overall_officials":134,"references":138,"see_also_links":139},"NCT07655232","2024P001945B","Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities","Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention","RECRUITING","2026-12-31","2026-06","2026-06-17","2025-11-17","Massachusetts General Hospital","OTHER",false,"The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 6 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.",null,[19,20,21,22],"Nursing Home Resident","Skilled Nursing Facility","Depression","Feasibility Studies",[],"INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},20,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals","The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills and emotion regulation skill with the goal of reducing depression symptoms.",[37],"InSTILL for Individuals",[39,43,47,50,54,57,60,63,66],{"measure":40,"description":41,"timeFrame":42},"Mean Total Score Treatment Credibility","3-item self-report measure of participant's belief regarding how helpful the intervention will be for them. Higher scores (min = 0, max = 30) scores indicate greater credibility.","After session 1 of intervention, an average of 1 week after baseline",{"measure":44,"description":45,"timeFrame":46},"Mean Total Score Client Satisfaction Questionnaire","3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.","Post intervention, an average of 4 weeks after baseline",{"measure":48,"description":49,"timeFrame":46},"Percentage of Eligible Participants Enrolled","Percentage of eligible approached individuals that are enrolled into the study.",{"measure":51,"description":52,"timeFrame":53},"Percentage of Participants with Missing Data","Percentage of all participants with no measure fully missing at 4-week follow-up.","4 weeks after post-intervention",{"measure":55,"description":56,"timeFrame":46},"Attendance Rate","Percentage of participants completing 4\u002F6 sessions of the intervention.",{"measure":58,"description":59,"timeFrame":46},"Clinician Fidelity","Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed.",{"measure":61,"description":62,"timeFrame":53},"Number of Adverse Events","Number of adverse events related to participation in the study.",{"measure":64,"description":65,"timeFrame":46},"Treatment Acceptability Survey","Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study).",{"measure":67,"description":68,"timeFrame":46},"Percentage of Participants Meeting Participant Comprehension Criterion","Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10)",[70,74,77,80,83,86,89,92,95],{"measure":71,"description":72,"timeFrame":73},"Patient Health Questionnaire-9","9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.","Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention",{"measure":75,"description":76,"timeFrame":73},"Selection, Optimization, and Compensation (SOC) in Everyday Use","4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life. Items are averaged for a composite score, with higher scores indicate greater SOC strategy use (Range = 1-6).",{"measure":78,"description":79,"timeFrame":73},"Committed Action Questionnaire","8-item self-report measure of pursuit of valued goals despite challenges and difficulties. Higher scores indicate greater use and effectiveness of emotional regulation skills (Range = 0-48).",{"measure":81,"description":82,"timeFrame":73},"General Anxiety Disorder-7","7-item self-report measure of anxiety symptoms. Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).",{"measure":84,"description":85,"timeFrame":73},"Euro QoL-5D 5L","6-item self-report measure of subjective health-related quality of life. Higher scores indicate worse health-related quality of life (Range = 5-25). The scale also includes a separately scored single-item global health indicator, asked on a 0-100 scale with higher scores indicate higher subjective health-related quality of life.",{"measure":87,"description":88,"timeFrame":46},"COREQ","4-item self-report of nursing facility satisfaction. Higher averaged scores indicate greater facility satisfaction (Range = 1-5).",{"measure":90,"description":91,"timeFrame":73},"University of Washington Resilience Scale Short Form","4-item self-report of an individual's perceived resilience. Summed scores will be converted to T-scores using a conversion table.",{"measure":93,"description":94,"timeFrame":73},"Psychotropic medication use","Chart or self reported psychotropic medication use. Patients will self-report changes to medication, including dosage, at post-intervention and follow-up",{"measure":96,"description":97,"timeFrame":98},"Re-hospitalization","Resident re-hospitalization during the study period","Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention","ALL","18 Years",{"inclusion":102,"exclusion":107,"raw_text":113},[103,104,105,106],"Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5","5+ chronic conditions based on Elixhauser Comorbidity Index","Aged ≥ 18 years","Able and willing to participate in the study",[108,109,110,111,112],"Intended length of SNF stay \\\u003C 7 days","More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) \\\u003C13","Participant's roommate is already enrolled in study\u002Fintervention","High risk of suicide\u002Factive documented SI per the PHQ-9, item 9 or otherwise","Participation in newly initiated psychotherapy","Inclusion Criteria:\n\n* Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5\n* 5+ chronic conditions based on Elixhauser Comorbidity Index\n* Aged ≥ 18 years\n* Able and willing to participate in the study\n\nExclusion Criteria:\n\n* Intended length of SNF stay \\\u003C 7 days\n* More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) \\\u003C13\n* Participant's roommate is already enrolled in study\u002Fintervention\n* High risk of suicide\u002Factive documented SI per the PHQ-9, item 9 or otherwise\n* Participation in newly initiated psychotherapy",[115,116],"ADULT","OLDER_ADULT",[118],{"facility":13,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":129},"Boston","Massachusetts","02114","United States",[124],{"name":125,"role":126,"phone":127,"email":128},"BRISK Study Coordinator","CONTACT","617-643-9406","brisk@mgb.org",{"lat":130,"lon":131},42.35843,-71.05977,[133],{"name":125,"role":126,"phone":127,"email":128},[135],{"name":136,"affiliation":13,"role":137},"Evan Plys, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":141,"biomarkers":142},[21],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]