Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals
BehavioralThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: InSTILL for IndividualsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean 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 baseline2
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 baseline3
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 baseline4
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-interventionSecondary outcomes
1
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-intervention2
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-intervention3
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-intervention4
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-interventionSponsors and contacts
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Source ClinicalTrials.gov