Depression, Feasibility Studies, Nursing Home Resident, Skilled Nursing Facility
Conditions
Brief summary
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
BEHAVIORALInterventions 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Score Treatment Credibility | After session 1 of intervention, an average of 1 week after baseline | 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. |
| Mean Total Score Client Satisfaction Questionnaire | Post intervention, an average of 4 weeks after baseline | 3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction. |
| Percentage of Eligible Participants Enrolled | Post intervention, an average of 4 weeks after baseline | Percentage of eligible approached individuals that are enrolled into the study. |
| Percentage of Participants with Missing Data | 4 weeks after post-intervention | Percentage of all participants with no measure fully missing at 4-week follow-up. |
| Attendance Rate | Post intervention, an average of 4 weeks after baseline | Percentage of participants completing 4/6 sessions of the intervention. |
| Clinician Fidelity | Post intervention, an average of 4 weeks after baseline | Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed. |
| Number of Adverse Events | 4 weeks after post-intervention | Number of adverse events related to participation in the study. |
| Treatment Acceptability Survey | Post intervention, an average of 4 weeks after baseline | Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study). |
| Percentage of Participants Meeting Participant Comprehension Criterion | Post intervention, an average of 4 weeks after baseline | Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | 9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms. |
| Selection, Optimization, and Compensation (SOC) in Everyday Use | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | 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). |
| Committed Action Questionnaire | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | 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). |
| General Anxiety Disorder-7 | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | 7-item self-report measure of anxiety symptoms. Higher scores indicate higher levels of anxiety symptoms (Range = 0-21). |
| Euro QoL-5D 5L | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | 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. |
| COREQ | Post intervention, an average of 4 weeks after baseline | 4-item self-report of nursing facility satisfaction. Higher averaged scores indicate greater facility satisfaction (Range = 1-5). |
| University of Washington Resilience Scale Short Form | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | 4-item self-report of an individual's perceived resilience. Summed scores will be converted to T-scores using a conversion table. |
| Psychotropic medication use | Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | Chart or self reported psychotropic medication use. Patients will self-report changes to medication, including dosage, at post-intervention and follow-up |
| Re-hospitalization | Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention | Resident re-hospitalization during the study period |
Countries
United States
Contacts
CONTACTBRISK Study Coordinator
PRINCIPAL_INVESTIGATOREvan Plys, PhD
Massachusetts General Hospital
Outcome results
None listed