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 their primary support person. The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful. The researchers will compare the InSTILL program to minimally enhanced usual care. Participants will be randomly assigned to receive either the InSTILL program or minimally enhanced usual care. Participants will complete assessments at three timepoints (all) and a brief-exit interview.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents and their care partners experiencing elevated levels of psychological distress. The intervention is designed to improve life management skills, emotion regulation skills, and dyadic coping skills with the goal of reducing depression symptoms among both dyad members (i.e., resident and care partner).
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGTreatment 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: peri-intervention
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: immediately after the intervention
Feasibility of Recruitment
Percentage of eligible approached dyads that are enrolled into the study.
Time frame: baseline, pre-intervention
Feasibility of Data Collection
Percentage of all participants with no measure fully missing at follow-up.
Time frame: 1 month follow-up
Treatment Adherence
Percentage of InSTILL participants completing 5/8 sessions
Time frame: immediately after the intervention
Clinician Fidelity
Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist.
Time frame: immediately after the intervention
Adverse Events
Any adverse events related to participation in the study.
Time frame: 1 month follow-up
Treatment Acceptability Survey
Percentage of InSTILL participants scoring above the scale midpoint on all 9 Treatment Acceptability Survey items (developed for the current study).
Time frame: immediately after the intervention
PHQ-9
9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Selection, Optimization, and Compensation in Everyday Use
4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Committed Action Questionnaire
8-item self-report measure of pursuit of valued goals despite challenges and difficulties
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Perceptions of Collaboration Questionnaire
12-item self-report measure of dyadic coping, including collaboration and interpersonal enjoyment.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
General Anxiety Disorder-7
7-item self-report measure of anxiety symptoms.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Euro QoL-5D 5L
6-item self-report measure of subjective health-related quality of life.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Relationship Assessment Scale
Single-item self-report measure of relationship satisfaction with study partner.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Preparedness for Future Care
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5-item self-report measure of active preparation for future health care needs.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
COREQ
4-item self-report of nursing facility satisfaction.
Time frame: immediately after the intervention
University of Washington Resilience Scale Short Form
4-item self-report of an individual's perceived resilience.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Zarit Burden Interview
4-item self-report screener of caregiver burden. Administered to care partners only.
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Psychotropic medication use
Chart or self reported psychotropic medication use
Time frame: baseline, pre-intervention; immediately after the intervention; 1 month follow-up
Re-hospitalization
Resident re-hospitalization during the study period
Time frame: immediately after the intervention; 1 month follow-up