20 Participants NeededMy employer runs this trial

Behavioral Program for Depression

(BRISK-I Trial)

BS
Overseen ByBRISK Study Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

EP

Evan Plys, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults living in skilled nursing facilities who are experiencing depression or distress, have at least five chronic health conditions, and can participate in group sessions. People with severe memory problems, a short expected stay, high suicide risk, or already starting new therapy can't join.

Inclusion Criteria

Psychological distress indicated by Patient Health Questionnaire-2 score ≥ 2 OR Patient Health Questionnaire-9 score ≥ 5
Having 5 or more chronic conditions based on Elixhauser Comorbidity Index
I am able and willing to take part in this study.
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Exclusion Criteria

Intended length of Skilled Nursing Facility (SNF) stay less than 7 days
More than mild cognitive impairment indicated by Brief Interview for Mental Status (BIMS) score less than 13
Participant's roommate is already enrolled in study or intervention
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants join 6 bi-weekly sessions of the InSTILL program, delivered in person or remotely

3 weeks
6 visits (in-person or remote)

Follow-up

Participants complete assessments and a brief-exit interview to monitor safety and effectiveness

4 weeks
3 visits (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

  • Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals

Trial Overview

The study tests a behavioral program called InSTILL to help residents cope with stress and depression during transitions into nursing homes. Participants attend six group sessions over three months and complete assessments before, during, and after the program.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: InSTILL for IndividualsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+