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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMean 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks after post-intervention
Attendance Rate
Percentage of participants completing 4/6 sessions of the intervention.
Time frame: 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.
Time frame: Post intervention, an average of 4 weeks after baseline
Number of Adverse Events
Number of adverse events related to participation in the study.
Time frame: 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).
Time frame: 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)
Time frame: Post intervention, an average of 4 weeks after baseline
Patient Health Questionnaire-9
9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.
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
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).
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Committed Action Questionnaire
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).
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
General Anxiety Disorder-7
7-item self-report measure of anxiety symptoms. Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Euro QoL-5D 5L
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.
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
COREQ
4-item self-report of nursing facility satisfaction. Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
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Time frame: Post intervention, an average of 4 weeks after baseline
University of Washington Resilience Scale Short Form
4-item self-report of an individual's perceived resilience. Summed scores will be converted to T-scores using a conversion table.
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Psychotropic medication use
Chart or self reported psychotropic medication use. Patients will self-report changes to medication, including dosage, at post-intervention and follow-up
Time frame: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
Re-hospitalization
Resident re-hospitalization during the study period
Time frame: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention