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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
Must not have
Current significant unstable medical illness precluding regular session attendance or assessment completion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-phase ii assessment at approximately week 7
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that would stop me from attending sessions or completing assessments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability Indicator: Satisfaction (Phase I)
Acceptability Indicator: Satisfaction (Phase II)
Feasibility Indicator: Enrollment (Phase I)
+7 more
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,088 Previous Clinical Trials
1,154,877 Total Patients Enrolled
JoAnn Difede, PhDPrincipal InvestigatorWeill Medical College of Cornell University
5 Previous Clinical Trials
344 Total Patients Enrolled
~63 spots leftby Jan 2028
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