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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment RESET for COVID-19 related stress?

Research shows that positive psychology interventions, like RESET, can improve mental wellbeing and reduce stress, depression, and anxiety symptoms, especially during challenging times like the COVID-19 pandemic. These interventions have been effective in boosting life satisfaction and overall wellbeing, particularly for individuals with fewer resiliency resources. ^{1 2 3 4 5}

Is the Positive Psychology Intervention for COVID-19 Related Stress safe for humans?

The available research on positive psychology interventions, including those similar to the one you're considering, suggests they are generally safe for humans. These interventions have been used to improve mental wellbeing and reduce stress without reported safety concerns. ^{1 2 3 4 6}

How does the RESET treatment for COVID-19 related stress differ from other treatments?

The RESET treatment is unique because it uses positive psychology interventions, which focus on enhancing well-being and resilience through activities like gratitude and optimism, rather than just addressing symptoms of stress or anxiety. This approach is particularly beneficial during crises like the COVID-19 pandemic, as it helps individuals build mental strength and improve overall life satisfaction. ^{1 3 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Six-Week Online Multi-component Positive Psychology Intervention Improves Subjective Wellbeing in Young Adults. [2022]

2. England 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. [2023]

3. England 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. [2022]

4. Switzerland 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. [2023]

5. England 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. [2023]

6. England 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Following the Science to Generate Well-Being: Using the Highest-Quality Experimental Evidence to Design Interventions. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

"Staying Home - Feeling Positive": Effectiveness of an on-line positive psychology group intervention during the COVID-19 pandemic. [2023]