Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
15 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
20
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: BRISK Study Coordinator
- Telefoonnummer: 617-643-9406
- E-mail: brisk@mgb.org
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02114
- Werving
- Massachusetts General Hospital
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Contact:
- BRISK Study Coordinator
- Telefoonnummer: 617-643-9406
- E-mail: brisk@mgb.org
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mean Total Score Treatment Credibility
Tijdsspanne: 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.
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After session 1 of intervention, an average of 1 week after baseline
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Mean Total Score Client Satisfaction Questionnaire
Tijdsspanne: Post intervention, an average of 4 weeks after baseline
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3-item self-report measure assessing patient satisfaction with the program.
Higher total scores (min = 3, max = 12) indicate greater satisfaction.
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Post intervention, an average of 4 weeks after baseline
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Percentage of Eligible Participants Enrolled
Tijdsspanne: Post intervention, an average of 4 weeks after baseline
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Percentage of eligible approached individuals that are enrolled into the study.
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Post intervention, an average of 4 weeks after baseline
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Percentage of Participants with Missing Data
Tijdsspanne: 4 weeks after post-intervention
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Percentage of all participants with no measure fully missing at 4-week follow-up.
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4 weeks after post-intervention
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Attendance Rate
Tijdsspanne: Post intervention, an average of 4 weeks after baseline
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Percentage of participants completing 4/6 sessions of the intervention.
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Post intervention, an average of 4 weeks after baseline
|
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Clinician Fidelity
Tijdsspanne: 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.
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Post intervention, an average of 4 weeks after baseline
|
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Number of Adverse Events
Tijdsspanne: 4 weeks after post-intervention
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Number of adverse events related to participation in the study.
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4 weeks after post-intervention
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Treatment Acceptability Survey
Tijdsspanne: 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).
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Post intervention, an average of 4 weeks after baseline
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Percentage of Participants Meeting Participant Comprehension Criterion
Tijdsspanne: 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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient Health Questionnaire-9
Tijdsspanne: 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.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Selection, Optimization, and Compensation (SOC) in Everyday Use
Tijdsspanne: 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).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Committed Action Questionnaire
Tijdsspanne: 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).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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General Anxiety Disorder-7
Tijdsspanne: 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).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Euro QoL-5D 5L
Tijdsspanne: 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.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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COREQ
Tijdsspanne: Post intervention, an average of 4 weeks after baseline
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4-item self-report of nursing facility satisfaction.
Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
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Post intervention, an average of 4 weeks after baseline
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University of Washington Resilience Scale Short Form
Tijdsspanne: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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4-item self-report of an individual's perceived resilience.
Summed scores will be converted to T-scores using a conversion table.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Psychotropic medication use
Tijdsspanne: 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
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Re-hospitalization
Tijdsspanne: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Resident re-hospitalization during the study period
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Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Evan Plys, PhD, Massachusetts General Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
17 november 2025
Primaire voltooiing (Geschat)
1 oktober 2026
Studie voltooiing (Geschat)
31 december 2026
Studieregistratiedata
Eerst ingediend
9 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
15 juni 2026
Eerst geplaatst (Werkelijk)
17 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
15 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024P001945B
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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