Nursing Home ResidentBRISK-INCT07655232
Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities
A study testing Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals in people with Nursing Home Resident and Skilled Nursing Facility, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents. 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
- Conditions the study is for
- Nursing Home Resident, Skilled Nursing Facility, Depression
- What is being tested?
- Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 28 Feb 2027
- 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
- Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5
- 5+ chronic conditions based on Elixhauser Comorbidity Index
- Aged ≥ 18 years
- Able and willing to participate in the study
Who cannot join
- Intended length of SNF stay < 7 days
- More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) <13
- Participant's roommate is already enrolled in study/intervention
- High risk of suicide/active documented SI per the PHQ-9, item 9 or otherwise
- Participation 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.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
BRISK Study Coordinator, 617-643-9406, brisk@mgb.org
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 Individuals) for skilled nursing facility residents. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 6 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) for Individuals
- 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) for IndividualsBehavioural
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 group | Role | What they receive |
|---|---|---|
| InSTILL for Individuals | Experimental | 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. InSTILL for Individuals includes 6 sessions (2x per week for about 3 weeks) delivered in person or remotely. Receives: Behavioral: Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Score 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: After session 1 of intervention, an average of 1 week after baseline
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, an average of 4 weeks after baseline
Percentage of Eligible Participants Enrolled
Percentage of eligible approached individuals that are enrolled into the study.
Measured: Post intervention, an average of 4 weeks after baseline
Percentage of Participants with Missing Data
Percentage of all participants with no measure fully missing at 4-week follow-up.
Measured: 4 weeks after post-intervention
Attendance Rate
Percentage of participants completing 4/6 sessions of the intervention.
Measured: Post intervention, an average of 4 weeks after baseline
Clinician Fidelity
Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed.
Measured: Post intervention, an average of 4 weeks after baseline
Number of Adverse Events
Number of adverse events related to participation in the study.
Measured: 4 weeks after post-intervention
Treatment Acceptability Survey
Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study).
Measured: Post intervention, an average of 4 weeks after baseline
Percentage of Participants Meeting Participant Comprehension Criterion
Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10)
Measured: Post intervention, an average of 4 weeks after baseline
Secondary outcomes (9)
Patient Health Questionnaire-9
9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.
Measured: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Committed Action Questionnaire
8-item self-report measure of pursuit of valued goals despite challenges and difficulties. Higher scores indicate greater use and effectiveness of emotional regulation skills (Range = 0-48).
Measured: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
General Anxiety Disorder-7
7-item self-report measure of anxiety symptoms. Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).
Measured: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
COREQ
4-item self-report of nursing facility satisfaction. Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
Measured: Post intervention, an average of 4 weeks after baseline
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: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Re-hospitalization
Resident re-hospitalization during the study period
Measured: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start17 Nov 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing Home ResidentStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evan Plys, Massachusetts General Hospital
- Investigators
- Evan Plys, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655232
- Sponsor's protocol ID
- 2024P001945B
- Acronym
- BRISK-I
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention
- ClinicalTrials.gov ID
- NCT07655232
- Acronym / sponsor ID
- BRISK-I / 2024P001945B
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 6 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InSTILL for Individuals | Experimental | Behavioral: Interventions for Stressful Transitions in Later Life (InSTILL) for IndividualsParticipants 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. InSTILL for Individuals includes 6 sessions (2x per week for about 3 weeks) delivered in person or remotely. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5
- 5+ chronic conditions based on Elixhauser Comorbidity Index
- Aged ≥ 18 years
- Able and willing to participate in the study
Key exclusion criteria (5 listed)
- Intended length of SNF stay < 7 days
- More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) <13
- Participant's roommate is already enrolled in study/intervention
- High risk of suicide/active documented SI per the PHQ-9, item 9 or otherwise
- Participation in newly initiated psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventions for Stressful Transitions in Later Life (InSTILL) for IndividualsThe 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. | Behavioural | InSTILL for Individuals |
Primary outcome
Mean Total Score Treatment Credibility
Time frame: After session 1 of intervention, an average of 1 week after baseline
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.
Mean Total Score Client Satisfaction Questionnaire
Time frame: Post intervention, an average of 4 weeks after baseline
3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction.
Percentage of Eligible Participants Enrolled
Time frame: Post intervention, an average of 4 weeks after baseline
Percentage of eligible approached individuals that are enrolled into the study.
Percentage of Participants with Missing Data
Time frame: 4 weeks after post-intervention
Percentage of all participants with no measure fully missing at 4-week follow-up.
Attendance Rate
Time frame: Post intervention, an average of 4 weeks after baseline
Percentage of participants completing 4/6 sessions of the intervention.
Clinician Fidelity
Time frame: Post intervention, an average of 4 weeks after baseline
Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed.
Number of Adverse Events
Time frame: 4 weeks after post-intervention
Number of adverse events related to participation in the study.
Treatment Acceptability Survey
Time frame: Post intervention, an average of 4 weeks after baseline
Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study).
Percentage of Participants Meeting Participant Comprehension Criterion
Time frame: Post intervention, an average of 4 weeks after baseline
Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10)
9 secondary outcomes
Patient Health Questionnaire-9
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Selection, Optimization, and Compensation (SOC) in Everyday Use
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Committed Action Questionnaire
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
General Anxiety Disorder-7
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Euro QoL-5D 5L
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
COREQ
Time frame: Post intervention, an average of 4 weeks after baseline
University of Washington Resilience Scale Short Form
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Psychotropic medication use
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Re-hospitalization
Time frame: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Nursing Home Resident
Active, not recruiting
Virtual Nature as a Health-promoting Intervention for Nursing Home Residents With Dementia
Dementia, Nursing Home Resident
Active, not recruiting
Sustainable Improvement of INTERprofessional Care for Better Resident Outcomes
Unplanned Hospitalizations
Recruiting
Behavioral Health Program for Short-Stay Nursing Facility Residents & Care Partners
Nursing Home Resident, Skilled Nursing Facility
Not yet recruitingObservational study
A Geriatric Mobile Team for Nursing Home Residents: a Feasibility Pilot Study
Nursing Home Resident, Geriatric Assessment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan Plys, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals 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 4 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 20 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?
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 BRISK Study Coordinator (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?
Mean Total Score Treatment Credibility (time frame: After session 1 of intervention, an average of 1 week after baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.