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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months from baseline, and 8 months from baseline

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met