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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I experience significant depression, anxiety, fatigue, loneliness, stress, or chronic pain.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in PROMIS-29 Mental (Psychosocial) Summary Score

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,377,682 Total Patients Enrolled

15 Trials studying Anxiety

9,302 Patients Enrolled for Anxiety

Detroit Department of HealthOTHER

2 Previous Clinical Trials

508 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,105 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the quota for recruitment into this research endeavor?

"Affirmative. Per the information provided on clinicaltrials.gov, this clinical study is actively soliciting participants since it was first posted in March 1st of 2023 and most recently updated May 30th of 2023. 456 individuals need to be recruited from one site for this trial."

Answered by AI

Are individuals still able to enter this medical experiment at this moment?

"Affirmative. According to clinicaltrials.gov, this research initiative that was initially posted on March 1st of 2023 is actively searching for participants. 456 people are necessary at one location in order to complete the trial which has had a recent update as of May 30th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic

Mary Janevic 2023. "A Trial of a Positive Psychology Intervention for Older Adults (RESET) During the COVID-19 Pandemic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05451589.