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

NCT ID: NCT07220486

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2028-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nursing Home Resident Skilled Nursing Facility Depression Feasibility Studies Caregiver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Interventions for Stressful Transitions in Later Life

Intervention Type 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).

Minimally Enhanced Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Evan Plys

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Evan Plys, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Makenna E Law, BS

Role: CONTACT

Phone: 617-643-9406

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

BRISK Study Team

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23AG078410

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P0001624

Identifier Type: -

Identifier Source: org_study_id