Psychological Interventions for Healthcare Workers' Distress Due to COVID-19

Recruiting in Palo Alto (17 mi)

Overseen by JoAnn Difede, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Weill Medical College of Cornell University

Must be taking: Psychotropics

Disqualifiers: Unstable illness, Schizophrenia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

It is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychotropic medication, it should be stable for at least 60 days before joining the study.

What data supports the effectiveness of the treatment Interpersonal Psychotherapy, IPT, Interpersonal Therapy, Medical Music, Narrative Writing, Prolonged Exposure Therapy, Prolonged Exposure, PE, Exposure Therapy for healthcare workers' distress due to COVID-19?

Research shows that expressive writing, a form of narrative writing, helped healthcare workers reduce symptoms of PTSD, depression, and overall psychological distress during the COVID-19 pandemic. Additionally, music therapy was found to significantly improve emotional well-being and reduce stress in clinical staff working with COVID-19 patients. ^{1 2 3 4 5}

Is the psychological intervention safe for healthcare workers?

The studies suggest that psychological interventions like expressive writing, narrative writing, and music therapy are generally safe for healthcare workers, as they have been used to help reduce stress and improve mental health without reported adverse effects. ^{1 2 4 6 7}

How does the treatment of Medical Music and Narrative Writing differ from other treatments for healthcare workers' distress due to COVID-19?

This treatment is unique because it combines Medical Music and Narrative Writing, which are non-drug interventions focusing on emotional expression and creative engagement. Unlike traditional therapies, it uses music to soothe and writing to help process emotions, offering a novel way to improve mental health by enhancing resilience and reducing psychological distress. ^{1 3 4 7 8}

Research Team

JoAnn Difede, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for healthcare workers over 18 who have been treating COVID-19 patients and are experiencing psychological distress. They must be able to consent, understand the study's requirements, and if on medication, be stable for 60 days. Those with PTSD can join Phase II. Exclusions include unstable medical conditions, risk of harm to self or others, psychotic disorders, or recent participation in other psychiatric treatment trials.

Inclusion Criteria

I can understand and agree to the study's requirements.

My mental health medication has not changed in the last 60 days.

My health condition is currently stable.

Exclusion Criteria

I have been in a clinical trial or received treatment for mental health issues or PTSD in the last 3 months.

You have been diagnosed with schizophrenia or another psychotic disorder at any point in your life.

I do not have any severe illnesses that would stop me from attending sessions or completing assessments.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants undergo either a narrative writing intervention or a medical music intervention over 4 sessions in 2 weeks

2 weeks

4 sessions (virtual)

Phase II Treatment

Participants meeting PTSD criteria choose between Interpersonal Therapy (IPT) or Exposure Therapy (ET), each consisting of ten 75-minute sessions scheduled twice weekly

5 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Interpersonal Psychotherapy (Behavioural Intervention)
• Medical Music (Behavioural Intervention)
• Narrative Writing (Behavioural Intervention)
• Prolonged Exposure Therapy (Behavioural Intervention)

Trial Overview The study tests interventions to alleviate psychological distress in healthcare workers due to COVID-19. Phase I involves narrative writing or medical music sessions; those with PTSD may choose between Interpersonal Therapy (IPT) or Exposure Therapy (ET) in Phase II. All treatments are delivered remotely over several weeks.

Participant Groups

Group I: Narrative Writing (Phase I) Experimental Treatment 1 Intervention

Participants will complete four narrative writing sessions that are 20 minutes in length each.

Group II: Medical Music (Phase I) Experimental Treatment 1 Intervention

Participants will complete four medical music sessions that are 20 minutes in length each.

Group III: Interpersonal Psychotherapy (Phase II) Active Control 1 Intervention

IPT is comprised of ten 75-minute sessions scheduled twice weekly.

Group IV: Prolonged Exposure Therapy (Phase II) Active Control 1 Intervention

ET is comprised of ten 75-minute sessions scheduled twice weekly.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

Findings from Research

A study involving 55 healthcare workers during the COVID-19 pandemic found that an expressive writing (EW) intervention significantly improved symptoms of PTSD, depression, and overall psychological distress compared to a neutral writing (NW) group.

The effectiveness of the EW intervention varied based on individual factors such as age, gender, and marital status, with younger, male, and married participants experiencing greater reductions in distress, while women and single participants showed increased social support and resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Expressive Writing on Healthcare Workers' Psychological Adjustment During the COVID-19 Pandemic. Procaccia, R., Segre, G., Tamanza, G., et al.[2023]

A study involving 34 clinical staff members showed that a 5-week remote music therapy intervention significantly improved their emotional status, reducing feelings of tiredness, sadness, fear, and worry.

The findings suggest that music therapy can be an effective support intervention for healthcare workers dealing with the stress of treating COVID-19 patients, even in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Receptive music therapy to reduce stress and improve wellbeing in Italian clinical staff involved in COVID-19 pandemic: A preliminary study. Giordano, F., Scarlata, E., Baroni, M., et al.[2023]

Healthcare workers treating COVID-19 patients reported significantly higher levels of posttraumatic stress symptoms (PTSS) compared to those working in non-COVID-19 wards, particularly due to witnessing patient deaths, which increased the likelihood of PTSS by four times.

Despite similar rates of probable depression and anxiety between both groups, the study highlights the need for targeted support for healthcare workers in COVID-19 settings to help them cope with the psychological impact of patient deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between witnessing patient death and mental health outcomes in frontline COVID-19 healthcare workers. Mosheva, M., Gross, R., Hertz-Palmor, N., et al.[2021]

During the COVID-19 pandemic, a survey of healthcare workers in a large Australian hospital revealed that 21% experienced moderate to severe depression, 20% had anxiety, and 29% showed symptoms of posttraumatic stress disorder (PTSD).

The psychological distress was linked to factors such as burnout, previous psychiatric history, the specific profession of the healthcare workers, and their resilience, highlighting the need for ongoing mental health support for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burnout and psychological distress amongst Australian healthcare workers during the COVID-19 pandemic. Dobson, H., Malpas, CB., Burrell, AJ., et al.[2021]

The RESTORE intervention, an online program designed for healthcare workers experiencing mental health issues due to COVID-19, was found to be feasible and safe, showing significant improvements in anxiety, depression, and PTSD symptoms among 21 participants.

This initial trial suggests that RESTORE could be an effective, evidence-based solution for addressing mental health challenges faced by frontline healthcare workers during mass trauma events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial findings on RESTORE for healthcare workers: an internet-delivered intervention for COVID-19-related mental health symptoms. Trottier, K., Monson, CM., Kaysen, D., et al.[2022]

A two-step telehealth intervention, including self-directed narrative writing and prolonged exposure therapy via videoconferencing, significantly improved PTSD symptoms in a frontline healthcare worker during the COVID-19 pandemic.

This case represents the first successful participant in a larger trial aimed at addressing psychological distress in healthcare workers, suggesting that remote mental health interventions can be effective and scalable for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Two-Phased Telehealth Model to Treat Post-Traumatic Stress Disorder in a Health Care Worker due to the COVID-19 Pandemic: A Case Report. Wang, CC., Difede, J.[2023]

A brief online course focused on mindfulness, mentalization, and self-compassion significantly improved resilience and reduced emotional distress among healthcare workers during the COVID-19 pandemic, as shown by a study involving 38 participants who completed the course.

The study highlights the feasibility and acceptability of such interventions, with 554 healthcare workers initially surveyed, indicating that even short, evidence-based mental health resources can be effective in crisis situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting resilience in healthcare workers during the COVID-19 pandemic with a brief online intervention. DeTore, NR., Sylvia, L., Park, ER., et al.[2022]

A digital learning package was developed to support the psychological wellbeing of UK healthcare workers during the COVID-19 pandemic, which was accessed over 17,600 times within a week of its release, indicating high demand and relevance.

The package, created through a rapid three-step process involving public input and expert review, provided evidence-based guidance on self-care, managing emotions, and creating psychologically safe work environments, and was positively evaluated for its usability and practical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigating the Psychological Impact of COVID-19 on Healthcare Workers: A Digital Learning Package. Blake, H., Bermingham, F., Johnson, G., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Benefits of Expressive Writing on Healthcare Workers' Psychological Adjustment During the COVID-19 Pandemic. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Receptive music therapy to reduce stress and improve wellbeing in Italian clinical staff involved in COVID-19 pandemic: A preliminary study. [2023]

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

The association between witnessing patient death and mental health outcomes in frontline COVID-19 healthcare workers. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Burnout and psychological distress amongst Australian healthcare workers during the COVID-19 pandemic. [2021]

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

Initial findings on RESTORE for healthcare workers: an internet-delivered intervention for COVID-19-related mental health symptoms. [2022]

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

A Two-Phased Telehealth Model to Treat Post-Traumatic Stress Disorder in a Health Care Worker due to the COVID-19 Pandemic: A Case Report. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Promoting resilience in healthcare workers during the COVID-19 pandemic with a brief online intervention. [2022]

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

Mitigating the Psychological Impact of COVID-19 on Healthcare Workers: A Digital Learning Package. [2023]