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Positive Psychology Intervention for COVID-19 Related Stress

N/A
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with elevated physical or psychosocial symptoms including 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), loneliness (score >=6 on 3-item UCLA Loneliness Scale), perceived stress (mean score >3 on the Perceived Stress Scale-4), and chronic pain (Self-reported pain in muscles or joints for >3 months, >4 mean pain intensity over last month, and >=1 day in past month when pain made it difficult to do usual activities)
Be older than 18 years old
Must not have
Severe cognitive impairment or dementia
Serious acute illness or hospitalization in last month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months from baseline, and 8 months from baseline
Awards & highlights

Summary

This trial seeks to improve psychosocial and physical functioning of African American older adults in Detroit, MI, through a resilience-building intervention led by CHWs, in order to reduce the impact of systemic racism and COVID-19.

Who is the study for?
This trial is for African American older adults over 50 in Detroit who are experiencing depression, anxiety, fatigue, loneliness, stress or chronic pain. Participants must have a phone and be comfortable speaking English. Those with severe acute illness, planned major surgery soon, cognitive impairments like dementia or conditions that affect study cooperation are excluded.
What is being tested?
RESET is being tested against a one-time wellness check control. RESET includes group calls, podcasts and activity trackers aiming to improve mental and physical health among participants at risk of poor functioning due to COVID-19's impact on their lives.
What are the potential side effects?
Since RESET involves non-medical interventions such as group telephone calls and podcasts rather than drugs or medical procedures, traditional side effects aren't expected. However, there may be emotional discomfort from discussing personal issues during the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience significant depression, anxiety, fatigue, loneliness, stress, or chronic pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe memory or thinking problems.
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I have not been seriously ill or hospitalized in the last month.
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I do not have any major surgeries planned that would stop me from joining the program.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months from baseline, and 8 months from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months from baseline, and 8 months from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in PROMIS-29 Mental (Psychosocial) Summary Score
Secondary study objectives
Change in Connor-Davidson Resilience Scale
Change in PROMIS-29 Physical Summary Score
Patient Global Impression of Change (Functioning)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RESET interventionExperimental Treatment1 Intervention
Participants will engage in a 7-week positive psychology and self-management group telephone-based program.
Group II: Wellness check controlActive Control1 Intervention
Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RESET
2021
N/A
~100

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,833 Previous Clinical Trials
6,422,672 Total Patients Enrolled
18 Trials studying Anxiety
9,466 Patients Enrolled for Anxiety
Detroit Department of HealthOTHER
2 Previous Clinical Trials
508 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
598 Previous Clinical Trials
10,377,706 Total Patients Enrolled
5 Trials studying Anxiety
882 Patients Enrolled for Anxiety

Media Library

RESET Clinical Trial Eligibility Overview. Trial Name: NCT05451589 — N/A
RESET 2023 Treatment Timeline for Medical Study. Trial Name: NCT05451589 — N/A
Anxiety Clinical Trial 2023: RESET Highlights & Side Effects. Trial Name: NCT05451589 — N/A
Anxiety Research Study Groups: Wellness check control, RESET intervention
~199 spots leftby Nov 2025
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