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NCT Number: NCT07655232

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

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.

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Key information

Conditions

Nursing Home Resident Behavior Behavioral Symptoms Depression Feasibility Studies Skilled Nursing Facility

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

BRISK Study Coordinator

CONTACT

[email protected]

617-643-9406

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean Total Score Treatment Credibility

    Time frame: 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.

  2. Mean Total Score Client Satisfaction Questionnaire

    Time frame: 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.

  3. Percentage of Eligible Participants Enrolled

    Time frame: Post intervention, an average of 4 weeks after baseline

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

  4. Percentage of Participants with Missing Data

    Time frame: 4 weeks after post-intervention

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

  5. Attendance Rate

    Time frame: Post intervention, an average of 4 weeks after baseline

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

  6. Clinician Fidelity

    Time frame: 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.

  7. Number of Adverse Events

    Time frame: 4 weeks after post-intervention

    Number of adverse events related to participation in the study.

  8. Treatment Acceptability Survey

    Time frame: 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).

  9. Percentage of Participants Meeting Participant Comprehension Criterion

    Time frame: 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)

Secondary outcomes

  1. Patient Health Questionnaire-9

    Time frame: 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.

  2. Selection, Optimization, and Compensation (SOC) in Everyday Use

    Time frame: 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).

  3. Committed Action Questionnaire

    Time frame: 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).

  4. General Anxiety Disorder-7

    Time frame: 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).

  5. Euro QoL-5D 5L

    Time frame: 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.

  6. COREQ

    Time frame: 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).

  7. University of Washington Resilience Scale Short Form

    Time frame: 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.

  8. Psychotropic medication use

    Time frame: 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

  9. Re-hospitalization

    Time frame: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention

    Resident re-hospitalization during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

BRISK Study Coordinator

CONTACT

[email protected]

617-643-9406

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention

Acronym: BRISK-I

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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