NCT04626050

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2022Apr 2028

First Submitted

Initial submission to the registry

November 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

6 years

First QC Date

November 10, 2020

Last Update Submit

July 30, 2025

Conditions

Post-traumatic Stress DisorderMoral Injury

Keywords

PTSDMoral InjuryPsychological DistressHealthcare WorkersCOVID-19COVID-19 Pandemic

Outcome Measures

Primary Outcomes (10)

  • Feasibility Indicator: Recruitment (Phase I)

    Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.

    Baseline

  • Feasibility Indicator: Recruitment (Phase II)

    Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.

    Post-Phase I Assessment at week 2

  • Feasibility Indicator: Enrollment (Phase I)

    Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

    Baseline

  • Feasibility Indicator: Enrollment (Phase II)

    Feasibility assessment will include enrollment defined as number of individuals beginning phase II.

    Post-Phase I Assessment at approximately week 2

  • Feasibility Indicator: Retention (Phase I)

    Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.

    Post-Phase I Assessment at approximately week 2

  • Feasibility Indicator: Retention (Phase II)

    Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.

    Post-Phase II Assessment at approximately week 7

  • Acceptability Indicator: Satisfaction (Phase I)

    Acceptability and treatment satisfaction will be rated with a Likert scale.

    Post-Phase I Assessment at approximately week 2

  • Acceptability Indicator: Satisfaction (Phase II)

    Acceptability and treatment satisfaction will be rated with a Likert scale.

    Post-Phase II Assessment at approximately week 7

  • Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)

    Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

    Start of Phase I to approximately 2 weeks

  • Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)

    Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

    Start of Phase II to approximately 5 weeks

Secondary Outcomes (28)

  • Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)

    Start of Phase I to approximately 2 weeks

  • Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)

    Start of Phase II to approximately 5 weeks

  • Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)

    Start of Phase I to approximately 2 weeks

  • Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)

    Start of Phase II to approximately 5 weeks

  • Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)

    Start of Phase I to approximately 2 weeks

  • +23 more secondary outcomes

Study Arms (4)

Medical Music (Phase I)

EXPERIMENTAL

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

Behavioral: Medical Music

Narrative Writing (Phase I)

EXPERIMENTAL

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

Behavioral: Narrative Writing

Interpersonal Psychotherapy (Phase II)

ACTIVE COMPARATOR

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

Behavioral: Interpersonal Psychotherapy

Prolonged Exposure Therapy (Phase II)

ACTIVE COMPARATOR

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

Behavioral: Prolonged Exposure Therapy

Interventions

Medical MusicBEHAVIORAL

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

Medical Music (Phase I)
Narrative WritingBEHAVIORAL

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

Narrative Writing (Phase I)
Prolonged Exposure TherapyBEHAVIORAL

Psychotherapy including imaginal exposure for PTSD

Prolonged Exposure Therapy (Phase II)
Interpersonal PsychotherapyBEHAVIORAL

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

Interpersonal Psychotherapy (Phase II)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

  • Wang CC, Difede J. A Two-Phased Telehealth Model to Treat Post-Traumatic Stress Disorder in a Health Care Worker due to the COVID-19 Pandemic: A Case Report. Telemed J E Health. 2024 Feb;30(2):601-606. doi: 10.1089/tmj.2023.0326. Epub 2023 Aug 16.

    PMID: 37585569DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCOVID-19

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • JoAnn Difede, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Baryluk, BS

CONTACT

212-821-0783olb4002@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will not be aware of the condition for Phase 1 or Phase 2 of the study.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 12, 2020

Study Start

January 20, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)