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NCT05451589 · ClinicalTrials.gov registry record · NA
A Trial of a Positive Psychology Intervention for Older Adults (RESET)
A NA study of Anxiety and Chronic Pain, sponsored by University of Michigan.
- Active
- Registry status
- NA
- Development phase
- 456
- Enrollment target
- 1
- Study location
NCT05451589: Active NA study of Anxiety and Chronic Pain, sponsored by University of Michigan.
NCT05451589 is a NA study of Anxiety and Chronic Pain that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 456 participants, roughly in line with the 439-participant average among 364 other Anxiety trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05451589, a NA study of Anxiety and Chronic Pain, is active but no longer recruiting, sponsored by University of Michigan.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 456 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Brief Description: The PROMIS-29 Mental (Psychosocial) Summary Score is a weighted composite of distress (depression and anxiety), pain (intensity and interference), social participation, fatigue, and sleep. Weights are provided in Hays et al (2018), "PROMIS-29 v2.0 profile physical and mental health summary scores", Quality of Life Research, 1885-1891. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means mor
Conditions Studied
Interventions
- BEHAVIORAL RESET
- BEHAVIORAL Wellness Check Control
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-06 |
| Phase | NA |
What the registry record for NCT05451589 still lists
NCT05451589 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 439-participant average among 364 other Anxiety trials with a reported enrollment target.
The record links to 6 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which RESET is the first listed.
NCT05451589 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05451589 about?
NCT05451589 is a clinical study titled "A Trial of a Positive Psychology Intervention for Older Adults (RESET)". 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 functio...
What is the current status of trial NCT05451589?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 456 participants. The study started on 2023-03-01. Estimated completion is 2026-06.
What conditions does trial NCT05451589 study?
This clinical trial studies the following conditions: Anxiety, Chronic Pain, Fatigue, Depressive Symptoms, Stress, Psychological.
What interventions are being tested in trial NCT05451589?
The interventions under investigation include: RESET (BEHAVIORAL), Wellness Check Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT05451589?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05451589 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05451589's enrollment target sits among peer trials
456 40th of 364 higher than 325 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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