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

Overseen By JoAnn Difede, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Psychotropics

Disqualifiers: Unstable illness, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 14

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover effective treatments for healthcare workers experiencing psychological distress from caring for COVID-19 patients. It involves two phases: the first phase offers either narrative writing or medical music sessions over two weeks. Participants diagnosed with PTSD (Post-Traumatic Stress Disorder) after Phase I can choose between two proven therapies, Interpersonal Psychotherapy (also known as Interpersonal Therapy) or Prolonged Exposure Therapy (also known as Exposure Therapy), in the second phase. Healthcare workers who have provided care for COVID-19 patients and feel distressed might be a good fit. All sessions are conveniently offered online. This unphased trial offers healthcare workers a unique opportunity to access supportive therapies tailored to their needs.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that Chinese five-element music reduced anxiety and insomnia among medical staff treating COVID-19. This finding suggests that music can ease stress and improve sleep. Research also indicates that writing about personal experiences helps healthcare workers manage moral distress, providing relief and improving mental health.

For those with PTSD, treatments like Interpersonal Therapy (IPT) and Exposure Therapy (ET) have undergone extensive study. Research shows these therapies are generally safe and well-tolerated. They are evidence-based, having been tested and found effective for PTSD.

Overall, the treatments in this study have proven safe and can help reduce stress and anxiety for healthcare workers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for distress in healthcare workers because they offer unique, non-drug approaches that cater to emotional and psychological healing. Medical Music uses curated music sessions to help alleviate stress, offering a calming effect that traditional therapies often overlook. Narrative Writing provides participants with a creative outlet to process their experiences, potentially enhancing self-reflection and emotional release. Both methods are brief, easily accessible, and can be integrated into busy schedules, making them practical alternatives to longer, more intensive therapies like Interpersonal Psychotherapy and Prolonged Exposure Therapy.

What evidence suggests that this trial's treatments could be effective for psychological distress in healthcare workers?

Research has shown that both music and writing can reduce stress and improve mental well-being in healthcare workers. In this trial, participants may receive Medical Music therapy, which studies indicate can lower stress levels and boost resilience. Specifically, music can ease physical and mental stress among nurses, especially when combined with other calming methods like aromatherapy.

Alternatively, participants may engage in Narrative Writing sessions. Evidence suggests that writing helps healthcare workers manage their emotions and stress, enhancing resilience during challenging times like the COVID-19 pandemic. Expressive writing has been shown to help manage sudden stress, providing a mental health boost. Both music and writing offer promising ways to support healthcare workers facing distress. ^{1 6 7 8 9}

Who Is on the Research Team?

JoAnn Difede, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Interpersonal Psychotherapy
• Medical Music
• Narrative Writing
• Prolonged Exposure Therapy

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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