Behavioral Health Program for Short-Stay Nursing Facility Residents & Care Partners
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient and care partner both aged ≥ 18 years
Patient with care partner (known person providing regular health-related, socioemotional, or practical support) willing to participate
Patient reporting depression symptoms on a screening tool (Patient Health Questionnaire)
Disqualifiers
Patient intended length of nursing facility stay < 7 days
Patient evidencing more than mild impairment on a cognitive screen (Brief Interview for Mental Status)
Patient's roommate in skilled nursing facility already enrolled in study/intervention
Either patient or care partner reporting high risk of suicidality, based on a standardized safety assessment tool
Trial design
Design model
Parallel
Treatments tested in this trial
Interventions for Stressful Transitions in Later Life
BehavioralThe 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: InSTILLExperimental treatment 1 intervention
Group B: Minimally Enhanced Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
peri-intervention2
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 intervention3
Feasibility of Recruitment
Percentage of eligible approached dyads that are enrolled into the study.
Time frame
baseline, pre-intervention4
Feasibility of Data Collection
Percentage of all participants with no measure fully missing at follow-up.
Time frame
1 month follow-upSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov