Behavioral Health Program for Nursing Home Residents

(BRISK Trial)

Overseen By Makenna E Law, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Short stay, Cognitive impairment, Suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help nursing home residents and their main support person manage stress during difficult transitions. The goal is to determine if "Interventions for Stressful Transitions in Later Life" is practical, satisfying, and useful compared to standard care, which includes basic educational resources and community support referrals. Participants will be randomly assigned to either participate in the program or receive the usual care, and their experiences will be assessed over time. This trial may suit nursing home residents who experience depression and have someone regularly assisting with their care and emotional support. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve stress management for many in similar situations.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a behavioral health program, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that the InSTILL program is safe for nursing home residents?

A previous study examined programs like the InSTILL program to help older adults adjust to living in nursing homes. These programs generally aim to reduce stress and ease the transition. Research has shown these programs are well-received and pose no physical health risks, as they focus on mental and emotional support rather than medication or surgery.

Although specific safety data for the InSTILL program is unavailable, similar programs are typically designed to be safe. They include activities such as discussions with a trained professional and learning coping strategies. Participants in similar programs have not reported serious side effects, indicating they are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the InSTILL program for stress management in nursing home residents because it offers a personalized, interactive approach that involves both the resident and their care partner. Unlike standard care options that might include medication or general counseling, this program focuses on the unique needs of short-stay residents, providing eight tailored sessions that can be delivered in person or remotely. This method fosters a supportive environment, encouraging active participation and collaboration, which may lead to improved transition experiences and mental well-being.

What evidence suggests that the InSTILL program is effective for nursing home residents?

Research has shown that programs like InSTILL, which participants in this trial may receive, can ease the transition into nursing homes for older adults. These programs reduce stress and aid emotional adjustment during significant life changes. By involving both the resident and a primary support person, they facilitate a smoother move. Other studies have found that focusing on these transitions can enhance mental health and overall happiness. The InSTILL program provides structured sessions to help residents and their supporters navigate this challenging time together. Participants in another arm of this trial will receive a psychoeducational pamphlet with enhanced referrals for community support resources. ^{1 2 3 6 7}

Who Is on the Research Team?

Evan Plys, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for skilled nursing facility residents and their primary support person, both aged 18 or older. Participants must be experiencing symptoms of depression as indicated by a screening tool. The care partner should be someone providing regular health-related, emotional, or practical support.

Inclusion Criteria

Both my care partner and I are 18 years old or older.

I have reported symptoms of depression.

I have someone willing to support me through my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the InSTILL program or minimally enhanced usual care. InSTILL includes 8 sessions (2x per week for about 4 weeks) delivered in person or remotely.

4 weeks

8 sessions (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 1 month follow-up.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Interventions for Stressful Transitions in Later Life

Trial Overview The study tests the InSTILL program designed to help with behavioral health during stressful transitions in later life. It will be compared to minimally enhanced usual care to see if it's feasible, satisfactory, and beneficial. Participants are randomly assigned to one of these two options.

How Is the Trial Designed?

Group I: InSTILL Experimental Treatment 1 Intervention

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.

Group II: Minimally Enhanced Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220486

Behavioral Health Program for Short-Stay Nursing Facility ... The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9372886/

Interventions to Improve the Transition From Home to a ... - PMC This project aims to summarize existing interventions for improving transitional care, identifying their effectiveness and key components.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224019252

Interventions that support major life transitions in older ... This study examined the effectiveness of interventions that target the three most common transitions in later life, namely bereavement, retirement, and ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/07317115.2023.2274042

Improving the Transition of Older Adults into Residential ... Our review provides a summary of interventions aimed at improving the transition experience for older adults moving into RAC and highlights gaps in the ...

5. scholarworks.waldenu.edu scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=19120&context=dissertations

Strategies for Improving the Transition Process Home After ... This proves the effectiveness of a systematic medication review in preventing medication errors and reducing hospital readmissions and is why ...

6. researchgate.net researchgate.net/publication/350006549_Interventions_to_Improve_the_Transition_From_Home_to_a_Nursing_Home_A_Scoping_Review

(PDF) Interventions to Improve the Transition From Home ... The study identified eight multi- and five single-component interventions. From the multi-component interventions, seven main components were ...

7. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-020-01987-w

The adaptation of older adults' transition to residential care ... The transition to residential care facilities can be stressful for older people, entailing numerous challenges.