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

Not Applicable

Not yet recruiting

• Conditions: Nursing Home Resident; Skilled Nursing Facility; Depression; Feasibility Studies; Caregiver

• Registration Number: NCT07220486
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-21
• Study First Submitted QC: 2025-10-22
• Last Update Submitted: 2025-10-22
• Study First Posted: 2025-10-24
• Last Update Posted: 2025-10-24
• Study Start: 2025-11-01
• Primary Completion: 2027-09
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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