Recruiting

InSTILL

Sponsor:

Massachusetts General Hospital

Code:

NCT07220486

Conditions

Nursing Home Resident

Skilled Nursing Facility

Depression

Feasibility Studies

Caregiver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interventions for Stressful Transitions in Later Life

Study Details

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

Study ID

NCT07220486

Start date

Nov 5, 2025

Status verified date

Nov, 2025

Completion date

May, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Minimally Enhanced Usual Care

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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Makenna E Law, BS

617-643-9406brisk@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

BRISK Study Team

617-643-9406brisk@mgb.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-10.