Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities

NCT07655232 | Recruiting

• 1 other identifier: 2024P001945B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nursing Home Resident; Skilled Nursing Facility; Depression; Feasibility Studies

Outcome Measures

Primary Outcomes (9)

• Mean Total Score Treatment Credibility

  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

  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

  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

  Percentage of all participants with no measure fully missing at 4-week follow-up.

  4 weeks after post-intervention

• Attendance Rate

  Percentage of participants completing 4/6 sessions of the intervention.

  Post intervention, an average of 4 weeks after baseline

• Clinician Fidelity

  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

  Number of adverse events related to participation in the study.

  4 weeks after post-intervention

• Treatment Acceptability Survey

  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

  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

Secondary Outcomes (9)

• Patient Health Questionnaire-9

  Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

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

  Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

• Committed Action Questionnaire

  Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

• General Anxiety Disorder-7

  Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

• Euro QoL-5D 5L

  Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

Study Arms (1)

InSTILL for Individuals

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. InSTILL for Individuals includes 6 sessions (2x per week for about 3 weeks) delivered in person or remotely.

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

Interventions

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

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 for Individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5
• + chronic conditions based on Elixhauser Comorbidity Index
• Aged ≥ 18 years
• Able and willing to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Evan Plys, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BRISK Study Coordinator

CONTACT

617-643-9406; brisk@mgb.org

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: June 9, 2026
• First Posted: June 17, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)