Caregiver, 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 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.
Interventions
BEHAVIORALInterventions for Stressful Transitions in Later Life
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).
Sponsors
National Institute on Aging (NIA)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Either patient or care partner participating in newly initiated psychotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Credibility | peri-intervention | 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. |
| Client Satisfaction Questionnaire | immediately after the intervention | 3-item self-report measure assessing patient satisfaction with the program. Higher total scores (min = 3, max = 12) indicate greater satisfaction. |
| Feasibility of Recruitment | baseline, pre-intervention | Percentage of eligible approached dyads that are enrolled into the study. |
| Feasibility of Data Collection | 1 month follow-up | Percentage of all participants with no measure fully missing at follow-up. |
| Treatment Adherence | immediately after the intervention | Percentage of InSTILL participants completing 5/8 sessions |
| Clinician Fidelity | immediately after the intervention | Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist. |
| Adverse Events | 1 month follow-up | Any adverse events related to participation in the study. |
| Treatment Acceptability Survey | immediately after the intervention | Percentage of InSTILL participants scoring above the scale midpoint on all 9 Treatment Acceptability Survey items (developed for the current study). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COREQ | immediately after the intervention | 4-item self-report of nursing facility satisfaction. |
| University of Washington Resilience Scale Short Form | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 4-item self-report of an individual's perceived resilience. |
| PHQ-9 | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms. |
| Psychotropic medication use | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | Chart or self reported psychotropic medication use |
| Re-hospitalization | immediately after the intervention; 1 month follow-up | Resident re-hospitalization during the study period |
| Zarit Burden Interview | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 4-item self-report screener of caregiver burden. Administered to care partners only. |
| Selection, Optimization, and Compensation in Everyday Use | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life. |
| Committed Action Questionnaire | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 8-item self-report measure of pursuit of valued goals despite challenges and difficulties |
| Perceptions of Collaboration Questionnaire | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 12-item self-report measure of dyadic coping, including collaboration and interpersonal enjoyment. |
| General Anxiety Disorder-7 | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 7-item self-report measure of anxiety symptoms. |
| Euro QoL-5D 5L | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 6-item self-report measure of subjective health-related quality of life. |
| Relationship Assessment Scale | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | Single-item self-report measure of relationship satisfaction with study partner. |
| Preparedness for Future Care | baseline, pre-intervention; immediately after the intervention; 1 month follow-up | 5-item self-report measure of active preparation for future health care needs. |
Countries
United States
Contacts
Primary ContactMakenna E Law, BS
Outcome results
None listed