General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Moral Injury; Post-traumatic Stress Disorder

Treatments: Behavioral: Narrative Writing; Behavioral: Prolonged Exposure Therapy; Behavioral: Medical Music; Behavioral: Interpersonal Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04626050

20-04021913

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Medical Music (Phase I)

Experimental group

Description:

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

Treatment:

Behavioral: Medical Music

Narrative Writing (Phase I)

Experimental group

Description:

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

Treatment:

Behavioral: Narrative Writing

Interpersonal Psychotherapy (Phase II)

Active Comparator group

Description:

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

Treatment:

Behavioral: Interpersonal Psychotherapy

Prolonged Exposure Therapy (Phase II)

Active Comparator group

Description:

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

Treatment:

Behavioral: Prolonged Exposure Therapy