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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-traumatic Stress Disorder Moral Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will not be aware of the condition for Phase 1 or Phase 2 of the study.

Study Groups

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Medical Music (Phase I)

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

Group Type EXPERIMENTAL

Medical Music

Intervention Type BEHAVIORAL

Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks

Narrative Writing (Phase I)

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

Group Type EXPERIMENTAL

Narrative Writing

Intervention Type BEHAVIORAL

Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks

Interpersonal Psychotherapy (Phase II)

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

Group Type ACTIVE_COMPARATOR

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning

Prolonged Exposure Therapy (Phase II)

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

Group Type ACTIVE_COMPARATOR

Prolonged Exposure Therapy

Intervention Type BEHAVIORAL

Psychotherapy including imaginal exposure for PTSD

Interventions

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Medical Music

Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks

Intervention Type BEHAVIORAL

Narrative Writing

Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks

Intervention Type BEHAVIORAL

Prolonged Exposure Therapy

Psychotherapy including imaginal exposure for PTSD

Intervention Type BEHAVIORAL

Interpersonal Psychotherapy

Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\- 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes