Positive Psychology Intervention for COVID-19 Related Stress

Overseen By Mary Janevic

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe psychiatric disorders, dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

456 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help African American older adults in Detroit manage stress related to COVID-19. The main focus is on testing RESET, a positive psychology program that includes group phone calls, podcasts, and activity tracking to improve mental and physical health. Researchers will compare participants to those receiving a one-time wellness check (Wellness Check Control). Individuals who have experienced ongoing stress, depression, anxiety, or chronic pain and can comfortably speak English on the phone may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance mental health support for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What prior data suggests that the RESET intervention is safe for participants?

Research has shown that programs like RESET, which help individuals manage their health and build resilience, are generally safe and well-received. Similar programs have improved mental health without causing harm. For instance, a program called RESTORE, similar to RESET, was safe and helped participants with anxiety, depression, and PTSD without major issues.

RESET employs positive psychology through group phone calls, podcasts, and activity trackers. These methods are engaging and have a strong safety record. Although specific data on RESET's safety is not yet available, the use of these proven techniques suggests it should be low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments being explored in this trial because they offer fresh approaches to managing COVID-19 related stress. The RESET intervention is unique because it combines positive psychology with self-management strategies in a 7-week telephone-based program, providing a structured yet flexible way for people to build resilience and well-being. On the other hand, the Wellness Check Control arm focuses on addressing unmet social needs through educational resources and personalized wellness check-ins with a Community Health Worker. These methods differ from current stress management techniques, which often lean heavily on medication or traditional face-to-face therapy, by providing accessible, community-focused support and empowering individuals to actively participate in their mental health care.

What evidence suggests that the RESET intervention could be effective for COVID-19 related stress?

Research has shown that programs like RESET, which participants in this trial may receive, focus on positive psychology and can enhance mental well-being and resilience. These programs aim to boost happiness and coping skills through activities such as group talks and self-care exercises. Studies have found that similar programs can reduce stress, anxiety, and depression, especially during challenging times like the COVID-19 pandemic. Participants in the Wellness Check control arm will receive educational information and a wellness check phone call, which has also proven effective in addressing issues like anxiety and depression. Overall, these methods are designed to improve well-being and enhance stress management. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have a cell or landline phone

Able to converse comfortably in English

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

Exclusion Criteria

I have severe memory or thinking problems.

I do not have any major surgeries planned that would stop me from joining the program.

You have other health problems or conditions that would make it hard for you to work with the study team or finish the study tasks. This might include serious mental health issues, thoughts of hurting yourself, a history of trying to hurt yourself, or problems with drugs or alcohol that are not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

RESET Intervention

Participants engage in a 7-week positive psychology and self-management group telephone-based program

7 weeks

Weekly group telephone calls

Follow-up

Participants are monitored for changes in psychosocial and physical functioning at 2 and 8 months

8 months

Assessments at 2 and 8 months

What Are the Treatments Tested in This Trial?

Interventions

• RESET
• Wellness Check Control

Trial Overview 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.

How Is the Trial Designed?

Group I: RESET intervention Experimental Treatment 1 Intervention

Participants will engage in a 7-week positive psychology and self-management group telephone-based program.

Group II: Wellness check control Active Control 1 Intervention

Participants will receive educational information and an individual wellness check phone call from a Community Health Worker to screen for unmet social needs.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Detroit Department of Health

Collaborator

Trials

3

Recruited

960+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

This pilot study explored the impact of positive reinforcement among ICU clinicians during the COVID-19 pandemic, suggesting that positive feedback can enhance resiliency and psychological wellness in healthcare workers.

Implementing a culture of deliberate positivity may be a low-cost and scalable strategy to improve teamwork and overall wellness in healthcare settings, addressing the issue of burnout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of positive reinforcement on teamwork climate, resiliency, and burnout during the COVID-19 pandemic: The TEAM-ICU (Transforming Employee Attitudes via Messaging strengthens Interconnection, Communication, and Unity) pilot study. Green, J., Berdahl, CT., Ye, X., et al.[2023]

A six-week online positive psychology intervention significantly improved life satisfaction and overall wellbeing in 326 participants compared to an active control group, with effects lasting up to seven weeks post-intervention.

The intervention was particularly effective in reducing depression and anxiety symptoms among individuals with low baseline resiliency resources, highlighting its potential as a supportive tool during challenging times like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-Week Online Multi-component Positive Psychology Intervention Improves Subjective Wellbeing in Young Adults. Chilver, MR., Gatt, JM.[2022]

A brief online intervention for medical personnel and first responders during the COVID-19 pandemic led to a 13% increase in positive emotions and a 44% decrease in negative emotions, indicating its efficacy in improving psychological well-being.

Participants in the high-dose intervention experienced significantly greater boosts in positive emotions, suggesting that more intensive engagement with the intervention may provide better psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boosting positive mood in medical and emergency personnel during the COVID-19 pandemic: preliminary evidence of efficacy, feasibility and acceptability of a novel online ambulatory intervention. Coifman, KG., Disabato, DD., Seah, THS., et al.[2021]

Coping First Aid (CFA) was successfully implemented as a tele-mental healthcare service for healthcare workers during the COVID-19 pandemic, with 513 sessions conducted for 273 clients over 24 months, indicating its feasibility and scalability.

Client feedback showed that CFA was beneficial, with 60% of respondents reporting high satisfaction and 74% willing to recommend the program, highlighting its effectiveness in providing mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing access to mental health supports for healthcare workers during the COVID-19 pandemic and beyond through a novel coaching program. Arnold, KT., Becker-Haimes, EM., Wislocki, K., et al.[2023]

A two-week positivity-oriented photography intervention significantly improved wellbeing and posttraumatic growth in 109 adults aged 21 to 80, compared to a control group.

The benefits of the intervention were sustained even one month after its completion, suggesting its potential as a low-cost and accessible therapeutic tool for enhancing mental health during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial (RCT) exploring the impact of a photography intervention on wellbeing and posttraumatic growth during the COVID-19 pandemic. Read, RK., Mason, OJ., Jones, CJ.[2023]

Positive psychology interventions (PPIs) have been shown to effectively enhance well-being, even during the challenges of the COVID-19 pandemic, based on a systematic review of 25 meta-analyses and high-quality randomized controlled trials.

The review identified four specific PPIs that demonstrated positive effects on well-being, particularly in non-Western countries, highlighting the need for further research to evaluate these interventions in diverse populations beyond WEIRD contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Following the Science to Generate Well-Being: Using the Highest-Quality Experimental Evidence to Design Interventions. Donaldson, SI., Cabrera, V., Gaffaney, J.[2022]

A study involving 150 participants showed that brief positive psychology interventions (PPIs) like nostalgia, gratitude, and best possible self (BPS) significantly improved self-esteem and social connectedness during COVID-19 lockdowns.

After two weeks, those who engaged in these PPIs reported lower fear of COVID-19 compared to a control group, highlighting the effectiveness of these interventions in enhancing well-being during challenging times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nostalgia, Gratitude, or Optimism: The Impact of a Two-Week Intervention on Well-Being During COVID-19. Dennis, A., Ogden, J.[2022]

A two-week online positive psychology intervention involving 82 Greek adults significantly reduced feelings of anxiety, depression, loneliness, and fear related to the COVID-19 pandemic, while enhancing resilience and positive emotions.

Participants in the intervention group showed marked improvements in psychosocial well-being compared to the control group, indicating that online psychological support can be effective during crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Staying Home - Feeling Positive": Effectiveness of an on-line positive psychology group intervention during the COVID-19 pandemic. Brouzos, A., Vassilopoulos, SP., Baourda, VC., et al.[2023]

A group intervention aimed at improving mental health during the COVID-19 pandemic was effective, as participants in the intervention group showed increased well-being, while a control group experienced a significant decline in mental health.

Before the intervention, 25.2% of individuals were at risk of ill health, but this number skyrocketed to 64.1% in the COVID control group, highlighting the importance of mental health interventions during crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an intervention to improve mental health during the COVID-19 quarantine: comparison with a COVID control group, and a pre-COVID intervention group. Gorbeña, S., Gómez, I., Govillard, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05451589

A Trial of a Positive Psychology Intervention for Older ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9645352/

ReStress mindset: An internet-delivered intervention that ... The “ReStress Mindset” is an internet-delivered intervention program designed to change the stress mindset and stress response of Greek university students in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172229/

A Pilot Pre-Post Interventional Study - PMC Meditation was found to have a positive effect on mood and anxiety for individuals in stressful situations including COVID-19, and was found to ...

4. withpower.com withpower.com/trial/phase-depression-7-2022-62ad8

Positive Psychology Intervention for COVID-19 Related ... The RESET treatment is unique because it uses positive psychology interventions, which focus on enhancing well-being and resilience through activities like ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S221478292500003X

Effects of COVID-19 e-mental health interventions E-mental health interventions have demonstrated their effectiveness in addressing prevalent mental health issues, particularly anxiety, depression, and stress.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8567930/

Development of RESTORE: an online intervention to ... Objectives: RESTORE was designed to address depression, anxiety, and posttraumatic stress disorder symptoms associated with exposure to COVID-19 ...

7. nature.com nature.com/articles/s41398-022-01965-3

an internet-delivered intervention for COVID-19-related ... RESTORE was found to be feasible and safe, and led to statistically significant and large effect size improvements in anxiety, depression, and PTSD symptoms.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8678542/

Relationship between self-care activities, stress and well ... Self-care partially mediates the relationship between stress and well-being during COVID-19 confinement in the general population in the total sample.