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Recruiting NCT07220486

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

No phase Interventional Nursing Home Resident Skilled Nursing Facility Depression Feasibility Studies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interventions for Stressful Transitions in Later Life.
Who it may be relevant to
Registry conditions: Nursing Home Resident, Skilled Nursing Facility, Depression, Feasibility Studies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Treatment Credibility [Time frame: peri-intervention]
  • Client Satisfaction Questionnaire [Time frame: immediately after the intervention]
  • Feasibility of Recruitment [Time frame: baseline, pre-intervention]
  • Feasibility of Data Collection [Time frame: 1 month follow-up]
  • Treatment Adherence [Time frame: immediately after the intervention]
  • Clinician Fidelity [Time frame: immediately after the intervention]
  • Adverse Events [Time frame: 1 month follow-up]
  • Treatment Acceptability Survey [Time frame: immediately after the intervention]
Secondary outcome measures (12)
  • PHQ-9 [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Selection, Optimization, and Compensation in Everyday Use [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Committed Action Questionnaire [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Perceptions of Collaboration Questionnaire [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • General Anxiety Disorder-7 [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Euro QoL-5D 5L [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Relationship Assessment Scale [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Preparedness for Future Care [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • COREQ [Time frame: immediately after the intervention]
  • University of Washington Resilience Scale Short Form [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Zarit Burden Interview [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]
  • Psychotropic medication use [Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07220486 · 2025P0001624 · K23AG078410

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗