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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Any healthcare worker providing medical care or support for COVID-19 patients - English-speaking - Age >18 - Medically stable - Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments - If on psychotropic medication stable for prior 60 days For phase II additional inclusion criteria: - Current diagnosis of PTSD

Exclusion Criteria

  • Current significant unstable medical illness precluding regular session attendance or assessment completion - Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk - Lifetime or current diagnosis of schizophrenia or other psychotic disorder - Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
The outcomes assessor will not be aware of the condition for Phase 1 or Phase 2 of the study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Medical Music (Phase I) 		Participants will complete four medical music sessions that are 20 minutes in length each.
  • Behavioral: Medical Music
    Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
Experimental
Narrative Writing (Phase I) 		Participants will complete four narrative writing sessions that are 20 minutes in length each.
  • Behavioral: Narrative Writing
    Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
Active Comparator
Interpersonal Psychotherapy (Phase II) 		IPT is comprised of ten 75-minute sessions scheduled twice weekly.
  • Behavioral: Interpersonal Psychotherapy
    Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning
Active Comparator
Prolonged Exposure Therapy (Phase II) 		ET is comprised of ten 75-minute sessions scheduled twice weekly.
  • Behavioral: Prolonged Exposure Therapy
    Psychotherapy including imaginal exposure for PTSD

Recruiting Locations

Weill Cornell Medicine
New York, New York 10065
Contact:
Olivia Baryluk, BS

More Details

NCT ID
NCT04626050
Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

Olivia Baryluk, BS
212-821-0783
olb4002@med.cornell.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.