Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04626050

Conditions

Post-traumatic Stress Disorder

Moral Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Medical Music

Narrative Writing

Prolonged Exposure Therapy

Interpersonal Psychotherapy

Study Details

Brief summary:

It is expected that large numbers of healthcare workers 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 adversely affected by occupational-related trauma.

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

Post-traumatic Stress Disorder

Moral Injury

Study ID

NCT04626050

Start date

Jan 20, 2022

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Any healthcare worker providing medical care or support who has experienced occupational-related trauma
  • 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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medical Music (Phase I)

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

experimental: Narrative Writing (Phase I)

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

active comparator: Interpersonal Psychotherapy (Phase II)

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

active comparator: Prolonged Exposure Therapy (Phase II)

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

Interventions

Medical Music

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

Narrative Writing

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

Prolonged Exposure Therapy

Psychotherapy including imaginal exposure for PTSD

Interpersonal Psychotherapy

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

Primary outcome measure

  • Feasibility Indicator: Recruitment (Phase I) [ Time Frame: Baseline ]
  • Feasibility Indicator: Recruitment (Phase II) [ Time Frame: Post-Phase I Assessment at week 2 ]
  • Feasibility Indicator: Enrollment (Phase I) [ Time Frame: Baseline ]
  • Feasibility Indicator: Enrollment (Phase II) [ Time Frame: Post-Phase I Assessment at approximately week 2 ]
  • Feasibility Indicator: Retention (Phase I) [ Time Frame: Post-Phase I Assessment at approximately week 2 ]
  • Feasibility Indicator: Retention (Phase II) [ Time Frame: Post-Phase II Assessment at approximately week 7 ]
  • Acceptability Indicator: Satisfaction (Phase I) [ Time Frame: Post-Phase I Assessment at approximately week 2 ]
  • Acceptability Indicator: Satisfaction (Phase II) [ Time Frame: Post-Phase II Assessment at approximately week 7 ]
  • Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I) [ Time Frame: Start of Phase I to approximately 2 weeks ]
  • Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II) [ Time Frame: Start of Phase II to approximately 5 weeks ]

Central Contacts and Locations

Central contacts

Olivia Baryluk, BS

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

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Principal Investigator:

JoAnn Difede, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • PTSD
  • Moral Injury
  • Psychological Distress
  • Healthcare Workers
  • Occupational Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-22.