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Nursing Home ResidentBRISKNCT07891546

Pilot Study of a Behavioral Program for Depression in Skilled Nursing Facility Residents and Care Partners

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 care partners. 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 (InSTILL)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
5 Feb 2025to 11 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 1
  • For residents, have a care partner who is willing to participate
  • For care partner, identifies as care partner of eligible participant, as indicated by providing regular health-related, socioemotional, or practical support
  • Aged ≥ 18 years
  • Able and willing to participate in the study

Who cannot join

  • For residents, intended length of SNF stay < 7 days
  • For residents, more than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) <13
  • For residents, participant's roommate is already enrolled in study/intervention
  • High risk of suicide
  • Participation in a newly initiated psychotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention

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 care partners. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 8 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Being tested
Interventions for Stressful Transitions in Later Life (InSTILL)
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 Life (InSTILL)Behavioural

    The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills and emotion regulation skill with the goal of reducing depression symptoms.

Study groups in NCT07891546
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 care partners. InSTILL includes 8 sessions (2x per week for about 4 weeks) delivered in person or remotely.
Receives: Behavioral: Interventions for Stressful Transitions in Later Life (InSTILL)

What is being measured

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

  1. Mean Total Score Treatment Credibility

    2-item self-report measure of participant's belief regarding how helpful the intervention will be for them. Higher scores (min = 0, max = 4) scores indicate greater credibility.

    Measured: After session 1 of intervention (one week after baseline)

  2. Mean Total Score 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: Post-intervention (week 6)

  3. Percentage of Eligible Participants Enrolled

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

    Measured: Post-intervention (week 6)

  4. Percentage of Participants with Missing Data

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

    Measured: 1-month follow-up (week 10)

  5. Attendance Rate

    Percentage of participants completing 6/8 sessions of the intervention.

    Measured: Post-intervention (week 6)

  6. Number of Adverse Events

    Number of adverse events related to participation in the study.

    Measured: 1-month follow-up (week 10)

Secondary outcomes (9)

  1. Patient Health Questionnaire-9

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

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  2. Selection, Optimization, and Compensation (SOC) in Everyday Use

    4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life. Items are averaged for a composite score, with higher scores indicate greater SOC strategy use (Range = 1-6).

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  3. PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a

    4-item self-report measure of ability to manage difficult emotions. Higher scores indicate greater use and effectiveness of emotional regulation skills; raw scores will be converted to T-scores (normed, M=50, SD=10).

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  4. PROMIS Global Mental Health-4

    4-item self report of overall emotional wellbeing. Raw scores are converted to T-scores (normed, M=50, SD=10)

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  5. Euro QoL-5D 5L

    6-item self-report measure of subjective health-related quality of life. Higher scores indicate worse health-related quality of life (Range = 5-25). The scale also includes a separately scored single-item global health indicator, asked on a 0-100 scale with higher scores indicate higher subjective health-related quality of life.

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  6. CoreQ

    4-item self-report of nursing facility satisfaction. Higher averaged scores indicate greater facility satisfaction (Range = 1-5).

    Measured: Post-intervention (week 6)

  7. University of Washington Resilience Scale Short Form

    4-item self-report of an individual's perceived resilience. Summed scores will be converted to T-scores using a conversion table.

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  8. Psychotropic medication use

    Chart or self reported psychotropic medication use. Patients will self-report changes to medication, including dosage, at post-intervention and follow-up

    Measured: pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  9. Re-hospitalization

    Resident re-hospitalization during the study period

    Measured: post-intervention (week 6); 1 month follow-up (week 10)

Timeline

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

  1. First posted23 Oct 2026
  2. Study start5 Feb 2025
  3. Primary completion11 Dec 2025
  4. Study completion11 Dec 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07891546
Sponsor's protocol ID
2024P001945A
Acronym
BRISK
Status last verified
Oct 2026
First submitted
5 Oct 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
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 (InSTILL) 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 5 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: finished, as of the sponsor's last update on 23 Oct 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Total Score Treatment Credibility (time frame: After session 1 of intervention (one week after baseline)). The study lists 6 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 NCT07891546.

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 23 Oct 2026.

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