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Nursing Home ResidentBRISKNCT07220486

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

A study testing Interventions for Stressful Transitions in Later Life in people with Nursing Home Resident and Skilled Nursing Facility, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interventions for Stressful Transitions in Later Life
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
5 Nov 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Makenna E Law, BS contact

617-643-9406

brisk@mgb.org

United States1 site, 1 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    BRISK Study Team, 617-643-9406, brisk@mgb.org

    Recruiting

Other trials in United States

About this study

Official title: Building Resilience in Skilled Nursing Care: A Behavioral Health Intervention for 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.

Being tested
Interventions for Stressful Transitions in Later Life
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interventions for Stressful Transitions in Later LifeBehavioural

    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).

Study groups in NCT07220486
Study groupRoleWhat they receive
InSTILLExperimentalParticipants 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.
Receives: Behavioral: Interventions for Stressful Transitions in Later Life
Minimally Enhanced Usual CareNo interventionParticipants in this group will receive a psychoeducational pamphlet with enhanced referrals for community support resources.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment Credibility

    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.

    Measured: peri-intervention

  2. Client Satisfaction Questionnaire

    3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.

    Measured: immediately after the intervention

  3. Feasibility of Recruitment

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

    Measured: baseline, pre-intervention

  4. Feasibility of Data Collection

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

    Measured: 1 month follow-up

  5. Treatment Adherence

    Percentage of InSTILL participants completing 5/8 sessions

    Measured: immediately after the intervention

  6. Clinician Fidelity

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

    Measured: immediately after the intervention

  7. Adverse Events

    Any adverse events related to participation in the study.

    Measured: 1 month follow-up

  8. Treatment Acceptability Survey

    Percentage of InSTILL participants scoring above the scale midpoint on all 9 Treatment Acceptability Survey items (developed for the current study).

    Measured: immediately after the intervention

Secondary outcomes (13)

  1. PHQ-9

    9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.

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

  2. Selection, Optimization, and Compensation in Everyday Use

    4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life.

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

  3. Committed Action Questionnaire

    8-item self-report measure of pursuit of valued goals despite challenges and difficulties

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

  4. Perceptions of Collaboration Questionnaire

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

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

  5. General Anxiety Disorder-7

    7-item self-report measure of anxiety symptoms.

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

  6. Euro QoL-5D 5L

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

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

  7. Relationship Assessment Scale

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

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

  8. Preparedness for Future Care

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

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

  9. COREQ

    4-item self-report of nursing facility satisfaction.

    Measured: immediately after the intervention

  10. University of Washington Resilience Scale Short Form

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

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

  11. Zarit Burden Interview

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

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

  12. Psychotropic medication use

    Chart or self reported psychotropic medication use

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

  13. Re-hospitalization

    Resident re-hospitalization during the study period

    Measured: immediately after the intervention; 1 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2025
  2. Study start5 Nov 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220486
Sponsor's protocol ID
2025P0001624
Other IDs
K23AG078410
Acronym
BRISK
Status last verified
Nov 2025
First submitted
21 Oct 2025
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Interventions for Stressful Transitions in Later Life in people with Nursing Home Resident and Skilled Nursing Facility, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Makenna E Law, BS (617-643-9406, brisk@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Credibility (time frame: peri-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07220486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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