NCT07891546

Brief Summary

The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL) for skilled nursing facility residents and care partners. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. Participants will join 8 bi-weekly sessions of the InSTILL program. Participants will complete assessments at three timepoints (all) and a brief-exit interview.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

10 months

First QC Date

October 5, 2026

Last Update Submit

October 16, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Mean Total Score Treatment Credibility

    2-item self-report measure of participant's belief regarding how helpful the intervention will be for them. Higher scores (min = 0, max = 4) scores indicate greater credibility.

    After session 1 of intervention (one 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.

    Post-intervention (week 6)

  • Percentage of Eligible Participants Enrolled

    Percentage of eligible approached individuals that are enrolled into the study.

    Post-intervention (week 6)

  • Percentage of Participants with Missing Data

    Percentage of all participants with no measure fully missing at follow-up.

    1-month follow-up (week 10)

  • Attendance Rate

    Percentage of participants completing 6/8 sessions of the intervention.

    Post-intervention (week 6)

  • Number of Adverse Events

    Number of adverse events related to participation in the study.

    1-month follow-up (week 10)

Secondary Outcomes (9)

  • Patient Health Questionnaire-9

    pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  • Selection, Optimization, and Compensation (SOC) in Everyday Use

    pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  • PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a

    pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  • PROMIS Global Mental Health-4

    pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  • Euro QoL-5D 5L

    pre-intervention (week 0); post-intervention (week 6); 1 month follow-up (week 10)

  • +4 more secondary outcomes

Study Arms (1)

InSTILL

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 and care partners. InSTILL includes 8 sessions (2x per week for about 4 weeks) delivered in person or remotely.

Behavioral: Interventions for Stressful Transitions in Later Life (InSTILL)

Interventions

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.

InSTILL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 1
  • For residents, have a care partner who is willing to participate
  • For care partner, identifies as care partner of eligible participant, as indicated by providing regular health-related, socioemotional, or practical support
  • Aged ≥ 18 years
  • Able and willing to participate in the study

You may not qualify if:

  • For residents, intended length of SNF stay \< 7 days
  • For residents, more than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) \<13
  • For residents, participant's roommate is already enrolled in study/intervention
  • High risk of suicide
  • Participation in a newly initiated psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 23, 2026

Study Start

February 5, 2025

Primary Completion

December 11, 2025

Study Completion

December 11, 2025

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations