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NCT Number: NCT07220486

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

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.

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Key information

Conditions

Nursing Home Resident Behavior Behavioral Symptoms Caregiver Depression Feasibility Studies Skilled Nursing Facility

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

BRISK Study Team

CONTACT

[email protected]

617-643-9406

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Treatment Credibility

    Time frame: 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.

  2. Client Satisfaction Questionnaire

    Time frame: 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.

  3. Feasibility of Recruitment

    Time frame: baseline, pre-intervention

    Percentage of eligible approached dyads that are enrolled into the study.

  4. Feasibility of Data Collection

    Time frame: 1 month follow-up

    Percentage of all participants with no measure fully missing at follow-up.

  5. Treatment Adherence

    Time frame: immediately after the intervention

    Percentage of InSTILL participants completing 5/8 sessions

  6. Clinician Fidelity

    Time frame: immediately after the intervention

    Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist.

  7. Adverse Events

    Time frame: 1 month follow-up

    Any adverse events related to participation in the study.

  8. Treatment Acceptability Survey

    Time frame: 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 outcomes

  1. PHQ-9

    Time frame: 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.

  2. Selection, Optimization, and Compensation in Everyday Use

    Time frame: 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.

  3. Committed Action Questionnaire

    Time frame: 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

  4. Perceptions of Collaboration Questionnaire

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

    12-item self-report measure of dyadic coping, including collaboration and interpersonal enjoyment.

  5. General Anxiety Disorder-7

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

    7-item self-report measure of anxiety symptoms.

  6. Euro QoL-5D 5L

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

    6-item self-report measure of subjective health-related quality of life.

  7. Relationship Assessment Scale

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

    Single-item self-report measure of relationship satisfaction with study partner.

  8. Preparedness for Future Care

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

    5-item self-report measure of active preparation for future health care needs.

  9. COREQ

    Time frame: immediately after the intervention

    4-item self-report of nursing facility satisfaction.

  10. University of Washington Resilience Scale Short Form

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

    4-item self-report of an individual's perceived resilience.

  11. Zarit Burden Interview

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

    4-item self-report screener of caregiver burden. Administered to care partners only.

  12. Psychotropic medication use

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

    Chart or self reported psychotropic medication use

  13. Re-hospitalization

    Time frame: immediately after the intervention; 1 month follow-up

    Resident re-hospitalization during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Makenna E Law, BS

CONTACT

[email protected]

617-643-9406

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: BRISK

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 24, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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