A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic
- Conditions
- Chronic PainDepressive SymptomsAnxietyLonelinessStress, PsychologicalFatigue
- Interventions
- Behavioral: RESETBehavioral: Wellness Check Control
- Registration Number
- NCT05451589
- Lead Sponsor
- University of Michigan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 456
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RESET intervention RESET Participants will engage in a 7-week positive psychology and self-management group telephone-based program. Wellness check control Wellness Check Control Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs.
- Primary Outcome Measures
Name Time Method Change in PROMIS-29 Mental (Psychosocial) Summary Score Baseline, 2 months from baseline, and 8 months from baseline 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 more of the concept being measured.
- Secondary Outcome Measures
Name Time Method Change in PROMIS-29 Physical Summary Score Baseline, 2 months from baseline, and 8 months from baseline The PROMIS-29 Physical Summary Score is a weighted composite of physical functioning (the domain weighted most heavily), pain, and social participation. 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 more of the concept being measured.
Change in Connor-Davidson Resilience Scale Baseline, 2 months from baseline, and 8 months from baseline This scale measures ability to bounce back from stressful times, on a 10-item scale made up of statements indicating use of resilient coping strategies, which respondents rate on a scale from (0) Never True At All to (4) True Nearly All the Time, for a total score range of 0 to 40. A higher score means greater resilience.
Patient Global Impression of Change (Functioning) 2 months from baseline, and 8 months from baseline How participant thinks their functioning has changed from baseline (much worse (1) to much better (7)). Higher score represents a better outcome.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States