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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG078410 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InSTILL | Experimental | Participants in this arm will participate in the Interventions for Stressful Transitions in Later Life (InSTILL), a behavioral health intervention tailored to the needs of short stay nursing facility residents and their primary care partner. InSTILL includes 8 sessions (2x per week for about 4 weeks) delivered in person or remotely. Both participants (e.g., resident and care partner) attend all sessions together, facilitated by a trained clinician. |
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| Minimally Enhanced Usual Care | No Intervention | Participants in this group will receive a psychoeducational pamphlet with enhanced referrals for community support resources. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventions for Stressful Transitions in Later Life | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | immediately after the intervention |
| Feasibility of Recruitment | Percentage of eligible approached dyads that are enrolled into the study. | baseline, pre-intervention |
| Feasibility of Data Collection | Percentage of all participants with no measure fully missing at follow-up. | 1 month follow-up |
| Treatment Adherence | Percentage of InSTILL participants completing 5/8 sessions | immediately after the intervention |
| Clinician Fidelity | Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist. | immediately after the intervention |
| Adverse Events | Any adverse events related to participation in the study. | 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ-9 | 9-item self-report measure of depression symptoms. Higher scores (min=0, max=27) indicate greater depressive symptoms. | baseline, pre-intervention; immediately after the intervention; 1 month follow-up |
| Selection, Optimization, and Compensation in Everyday Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Makenna E Law, BS | Contact | 617-643-9406 | brisk@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Evan Plys, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Treatment Acceptability Survey |
Percentage of InSTILL participants scoring above the scale midpoint on all 9 Treatment Acceptability Survey items (developed for the current study). |
| immediately after the intervention |
4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life. |
| 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 | 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. | baseline, pre-intervention; immediately after the intervention; 1 month follow-up |
| General Anxiety Disorder-7 | 7-item self-report measure of anxiety symptoms. | 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. | 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. | baseline, pre-intervention; immediately after the intervention; 1 month follow-up |
| Preparedness for Future Care | 5-item self-report measure of active preparation for future health care needs. | baseline, pre-intervention; immediately after the intervention; 1 month follow-up |
| COREQ | 4-item self-report of nursing facility satisfaction. | immediately after the intervention |
| University of Washington Resilience Scale Short Form | 4-item self-report of an individual's perceived resilience. | 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. | baseline, pre-intervention; immediately after the intervention; 1 month follow-up |
| Psychotropic medication use | Chart or self reported psychotropic medication use | baseline, pre-intervention; immediately after the intervention; 1 month follow-up |
| Re-hospitalization | Resident re-hospitalization during the study period | immediately after the intervention; 1 month follow-up |