CompletedNot Applicable

A Trial of a Positive Psychology Intervention for Older Adults (RESET)

United States457 participantsStarted 2023-03-01

Plain-language summary

The heightened vulnerability to COVID-19 of African American older adults in Detroit, Michigan and other marginalized communities is linked to systemic racism experienced over the life course. Structural inequities also magnify the pandemic's impact on older adults' physical and psychosocial functioning. Many older adults in Detroit, burdened by poor health even before the pandemic, face a downward spiral of increased distress, reduced physical and social activity, and physical deconditioning. RESET (Re-Engaging in Self-care, Enjoying Today) is a self-management and resilience-building intervention led by community health workers (CHWs) at the Detroit Health Department (DHD). The central hypothesis of this study is that RESET, with components that include group telephone calls, a podcast series, and activity trackers, will improve psychosocial and physical functioning at 2 and 8 months. Specific aims are: 1) With input from a Community Advisory Board, modify RESET for group delivery and refine content after testing in a mini-pilot (n=10). 2) Conduct a randomized, controlled trial to assess the impact of RESET (compared to a one-time /telephone wellness check) on PROMIS-29 Psychosocial Score (a weighted combination of distress, fatigue, pain, social participation and sleep) among 456 primarily African American older adults age 50 and over who are at elevated risk of poor functioning. 3) Collect qualitative (interview) data from participants and other stakeholders, and use this data to better understand trial results, as well as to assess community impact and inform a dissemination toolkit.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any elevated physical or psychosocial symptoms as follows: Depression: Score ≥3 on the Patient Health Questionnaire-2 (PHQ-2); Anxiety: Score \>= 3 on the GAD-2 anxiety screening scale; Fatigue: Rating \>=4 on a 0 to 10 scale (0 = fatigued at all and 10 = extremely fatigued); Loneliness, as indicated by a score \>=6 on 3-item UCLA Loneliness Scale; Perceived stress, as indicated by a mean score \>3 on the Perceived Stress Scale-4; Chronic pain: Self-reported pain in muscles or joints for \>3 months, \>4 (0-10 scale) mean pain intensity over last month, and \>=1 day in past month when pain made it difficult to do usual activities. * Have a cell or landline phone. * Able to converse comfortably in English. Exclusion Criteria: * Serious acute illness or hospitalization in last month. * Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement). * Severe cognitive impairment or dementia. * Any other diseases or conditions that would impair cooperation with the study team or ability to complete study procedures, as determined by the clinicians on the investigative team. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in PROMIS-29 Mental (Psychosocial) Summary Score

Timeframe: Baseline, 2 months from baseline, and 8 months from baseline

Trial details

NCT IDNCT05451589

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-28

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