Recruiting NCT07655232
Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals.
- Who it may be relevant to
- Registry conditions: Nursing Home Resident, Skilled Nursing Facility, Depression, Feasibility Studies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention
Overview
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.
Interventions
- Behavioral 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.
Primary outcome measures
- Mean Total Score Treatment Credibility [Time frame: After session 1 of intervention, an average of 1 week after baseline]
- Mean Total Score Client Satisfaction Questionnaire [Time frame: Post intervention, an average of 4 weeks after baseline]
- Percentage of Eligible Participants Enrolled [Time frame: Post intervention, an average of 4 weeks after baseline]
- Percentage of Participants with Missing Data [Time frame: 4 weeks after post-intervention]
- Attendance Rate [Time frame: Post intervention, an average of 4 weeks after baseline]
- Clinician Fidelity [Time frame: Post intervention, an average of 4 weeks after baseline]
- Number of Adverse Events [Time frame: 4 weeks after post-intervention]
- Treatment Acceptability Survey [Time frame: Post intervention, an average of 4 weeks after baseline]
- Percentage of Participants Meeting Participant Comprehension Criterion [Time frame: Post intervention, an average of 4 weeks after baseline]
Secondary outcome measures (9)
- Patient Health Questionnaire-9 [Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
- 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]
- Committed Action Questionnaire [Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
- General Anxiety Disorder-7 [Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
- Euro QoL-5D 5L [Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
- COREQ [Time frame: Post intervention, an average of 4 weeks after baseline]
- University of Washington Resilience Scale Short Form [Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
- Psychotropic medication use [Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
- Re-hospitalization [Time frame: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07655232 · 2024P001945B