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Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)

15. juni 2026 opdateret af: Evan Plys, Massachusetts General Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: BRISK Study Coordinator
  • Telefonnummer: 617-643-9406
  • E-mail: brisk@mgb.org

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
        • Kontakt:
          • BRISK Study Coordinator
          • Telefonnummer: 617-643-9406
          • E-mail: brisk@mgb.org

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: InSTILL for Individuals
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.
Adfærdsmæssigt: Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Total Score Treatment Credibility
Tidsramme: 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.
After session 1 of intervention, an average of 1 week after baseline
Mean Total Score Client Satisfaction Questionnaire
Tidsramme: 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.
Post intervention, an average of 4 weeks after baseline
Percentage of Eligible Participants Enrolled
Tidsramme: Post intervention, an average of 4 weeks after baseline
Percentage of eligible approached individuals that are enrolled into the study.
Post intervention, an average of 4 weeks after baseline
Percentage of Participants with Missing Data
Tidsramme: 4 weeks after post-intervention
Percentage of all participants with no measure fully missing at 4-week follow-up.
4 weeks after post-intervention
Attendance Rate
Tidsramme: Post intervention, an average of 4 weeks after baseline
Percentage of participants completing 4/6 sessions of the intervention.
Post intervention, an average of 4 weeks after baseline
Clinician Fidelity
Tidsramme: 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.
Post intervention, an average of 4 weeks after baseline
Number of Adverse Events
Tidsramme: 4 weeks after post-intervention
Number of adverse events related to participation in the study.
4 weeks after post-intervention
Treatment Acceptability Survey
Tidsramme: 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).
Post intervention, an average of 4 weeks after baseline
Percentage of Participants Meeting Participant Comprehension Criterion
Tidsramme: 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)
Post intervention, an average of 4 weeks after baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Health Questionnaire-9
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Selection, Optimization, and Compensation (SOC) in Everyday Use
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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).
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Committed Action Questionnaire
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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).
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
General Anxiety Disorder-7
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
7-item self-report measure of anxiety symptoms. Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Euro QoL-5D 5L
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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.
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
COREQ
Tidsramme: Post intervention, an average of 4 weeks after baseline
4-item self-report of nursing facility satisfaction. Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
Post intervention, an average of 4 weeks after baseline
University of Washington Resilience Scale Short Form
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
4-item self-report of an individual's perceived resilience. Summed scores will be converted to T-scores using a conversion table.
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Psychotropic medication use
Tidsramme: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Chart or self reported psychotropic medication use. Patients will self-report changes to medication, including dosage, at post-intervention and follow-up
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Re-hospitalization
Tidsramme: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Resident re-hospitalization during the study period
Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Massachusetts General Hospital

Efterforskere

  • Ledende efterforsker: Evan Plys, PhD, Massachusetts General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. november 2025

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024P001945B

Plan for individuelle deltagerdata (IPD)

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