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

NCT07220486 | Recruiting DMC

• 2 other identifiers: 2025P0001624K23AG078410
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nursing Home Resident; Skilled Nursing Facility; Depression; Feasibility Studies; Caregiver

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (13)

• PHQ-9

  baseline, pre-intervention; immediately after the intervention; 1 month follow-up

• Selection, Optimization, and Compensation in Everyday Use

  baseline, pre-intervention; immediately after the intervention; 1 month follow-up

• Committed Action Questionnaire

  baseline, pre-intervention; immediately after the intervention; 1 month follow-up

• Perceptions of Collaboration Questionnaire

  baseline, pre-intervention; immediately after the intervention; 1 month follow-up

• General Anxiety Disorder-7

  baseline, pre-intervention; immediately after the intervention; 1 month follow-up

Study Arms (2)

InSTILL

EXPERIMENTAL

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

Minimally Enhanced Usual Care

NO INTERVENTION

Participants in this group will receive a psychoeducational pamphlet with enhanced referrals for community support resources.

Interventions

Interventions for Stressful Transitions in Later Life BEHAVIORAL

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).

InSTILL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Evan Plys, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makenna E Law, BS

CONTACT

617-643-9406; brisk@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 24, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)