Behavioral Health Program for Short-Stay Nursing Facility Residents & Care Partners (BRISK)

Building Resilience in Skilled Nursing Care: A Behavioral Health Intervention for Residents & Care Partners

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Study Overview

• Status: Recruiting
• Conditions: Depression; Feasibility Studies; Caregiver; Skilled Nursing Facility; Nursing Home Resident
• Intervention / Treatment: Behavioral: Interventions for Stressful Transitions in Later Life

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Makenna E Law, BS; Phone Number: 617-643-9406; Email: brisk@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: BRISK Study Team; Phone Number: 617-643-9406; Email: brisk@mgb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient and care partner both aged ≥ 18 years
• Patient with care partner (known person providing regular health-related, socioemotional, or practical support) willing to participate
• Patient reporting depression symptoms on a screening tool (Patient Health Questionnaire)

Exclusion Criteria:

• Patient intended length of nursing facility stay < 7 days
• Patient evidencing more than mild impairment on a cognitive screen (Brief Interview for Mental Status)
• Patient's roommate in skilled nursing facility already enrolled in study/intervention
• Either patient or care partner reporting high risk of suicidality, based on a standardized safety assessment tool
• Either patient or care partner participating in newly initiated psychotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: InSTILL; Participants in this arm will participate in the Interventions for Stressful Transitions in Later Life (InSTILL), a behavioral health intervention tailored to the needs of short stay nursing facility residents and their primary care partner. InSTILL includes 8 sessions (2x per week for about 4 weeks) delivered in person or remotely. Both participants (e.g., resident and care partner) attend all sessions together, facilitated by a trained clinician.	Behavioral: Interventions for Stressful Transitions in Later Life; The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents and their care partners experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills, emotion regulation skills, and dyadic coping skills with the goal of reducing depression symptoms among both dyad members (i.e., resident and care partner).
No Intervention: Minimally Enhanced Usual Care; Participants in this group will receive a psychoeducational pamphlet with enhanced referrals for community support resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	peri-intervention
Client Satisfaction Questionnaire	3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.	immediately after the intervention
Feasibility of Recruitment	Percentage of eligible approached dyads that are enrolled into the study.	baseline, pre-intervention
Feasibility of Data Collection	Percentage of all participants with no measure fully missing at follow-up.	1 month follow-up
Treatment Adherence	Percentage of InSTILL participants completing 5/8 sessions	immediately after the intervention
Clinician Fidelity	Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist.	immediately after the intervention
Adverse Events	Any adverse events related to participation in the study.	1 month follow-up
Treatment Acceptability Survey	Percentage of InSTILL participants scoring above the scale midpoint on all 9 Treatment Acceptability Survey items (developed for the current study).	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9	9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Selection, Optimization, and Compensation in Everyday Use	4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Committed Action Questionnaire	8-item self-report measure of pursuit of valued goals despite challenges and difficulties	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Perceptions of Collaboration Questionnaire	12-item self-report measure of dyadic coping, including collaboration and interpersonal enjoyment.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
General Anxiety Disorder-7	7-item self-report measure of anxiety symptoms.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Euro QoL-5D 5L	6-item self-report measure of subjective health-related quality of life.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Relationship Assessment Scale	Single-item self-report measure of relationship satisfaction with study partner.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Preparedness for Future Care	5-item self-report measure of active preparation for future health care needs.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
COREQ	4-item self-report of nursing facility satisfaction.	immediately after the intervention
University of Washington Resilience Scale Short Form	4-item self-report of an individual's perceived resilience.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Zarit Burden Interview	4-item self-report screener of caregiver burden. Administered to care partners only.	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Psychotropic medication use	Chart or self reported psychotropic medication use	baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Re-hospitalization	Resident re-hospitalization during the study period	immediately after the intervention; 1 month follow-up

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Evan Plys, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: October 21, 2025
• First Submitted That Met QC Criteria: October 22, 2025
• First Posted (Estimated): October 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Investigative Techniques; Methods
• Other Study ID Numbers: 2025P0001624; K23AG078410 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No