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

N/A
Recruiting
Led By JoAnn Difede, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
- Current diagnosis of PTSD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-phase ii assessment at approximately week 7
Awards & highlights

Study Summary

This trial is looking for interventions to help treat psychological distress in healthcare workers caring for COVID-19 patients. There are two phases to the study. In the first phase, participants will do either a narrative writing intervention or a medical music intervention. In the second phase, participants will be offered a choice of two treatments for PTSD: Interpersonal Therapy or Exposure Therapy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from therapies could include emotional discomfort during sessions like sadness while discussing traumatic events or anxiety when exposed to reminders of trauma during exposure therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and agree to the study's requirements.
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I have been diagnosed with PTSD.
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I am older than 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Acceptability Indicator: Satisfaction (Phase I)
Acceptability Indicator: Satisfaction (Phase II)
Feasibility Indicator: Enrollment (Phase I)
+7 more
Secondary outcome measures
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)
+24 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Narrative Writing (Phase I)Experimental Treatment1 Intervention
Participants will complete four narrative writing sessions that are 20 minutes in length each.
Group II: Medical Music (Phase I)Experimental Treatment1 Intervention
Participants will complete four medical music sessions that are 20 minutes in length each.
Group III: Interpersonal Psychotherapy (Phase II)Active Control1 Intervention
IPT is comprised of ten 75-minute sessions scheduled twice weekly.
Group IV: Prolonged Exposure Therapy (Phase II)Active Control1 Intervention
ET is comprised of ten 75-minute sessions scheduled twice weekly.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Music
2019
N/A
~10
Narrative Writing
2019
N/A
~330

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,985 Total Patients Enrolled
JoAnn Difede, PhDPrincipal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
344 Total Patients Enrolled

Frequently Asked Questions

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

What is the primary purpose of this experiment?

"The main outcome assessed in this trial at approximately week 2 is the Acceptability Indicator: Satisfaction (Phase I). Secondary objectives include measurement of Change in Depressive Symptoms, as evaluated by the Beck Depression Inventory-II (BDI-II); with scores ranging from 0 to 63 and higher scores indicating greater symptom severity. As well as, evaluation of Change in Anxiety Symptoms through the Generalized Anxiety Disorder 7-Item Scale; which ranges between 0 - 21 and a cut off score range between none to severe anxiety. Lastly, assessment of Change in Score on the Occupational Stress Inventory Revised (OSI-R) will be conducted;"

Answered by AI

Is this research endeavor actively seeking new participants?

"According to the information available on clinicaltrials.gov, this research endeavour is currently looking for enrollees and was initially advertised on January 20th 2022 with a recent update occurring August 22nd of the same year."

Answered by AI

What is the cohort size of this research endeavor?

"Affirmative. According to the clinicaltrials.gov database, this research initiative is actively searching for participants. The study was initially posted on January 20th 2022 and has been recently updated on August 22nd 2022. 120 patients are required at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19
2022. "General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626050.
All > Ptsd New York > Psychological
~24 spots leftby Jan 2025
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