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NCT Number: NCT04626050

General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Moral Injury Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

JoAnn Difede, PhD

PRINCIPAL_INVESTIGATOR

Olivia Baryluk, BS

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical Music

Behavioral

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

Narrative Writing

Behavioral

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

Prolonged Exposure Therapy

Behavioral

Psychotherapy including imaginal exposure for PTSD

interpersonal psychotherapy

Behavioral

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

Primary outcomes

  1. Feasibility Indicator: Recruitment (Phase I)

    Time frame: Baseline

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

  2. Feasibility Indicator: Recruitment (Phase II)

    Time frame: Post-Phase I Assessment at week 2

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

  3. Feasibility Indicator: Enrollment (Phase I)

    Time frame: Baseline

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

  4. Feasibility Indicator: Enrollment (Phase II)

    Time frame: Post-Phase I Assessment at approximately week 2

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

  5. Feasibility Indicator: Retention (Phase I)

    Time frame: Post-Phase I Assessment at approximately week 2

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

  6. Feasibility Indicator: Retention (Phase II)

    Time frame: Post-Phase II Assessment at approximately week 7

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

  7. Acceptability Indicator: Satisfaction (Phase I)

    Time frame: Post-Phase I Assessment at approximately week 2

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

  8. Acceptability Indicator: Satisfaction (Phase II)

    Time frame: Post-Phase II Assessment at approximately week 7

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

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

    Time frame: Start of Phase I to approximately 2 weeks

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

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

    Time frame: Start of Phase II to approximately 5 weeks

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

Secondary outcomes

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

    Time frame: Start of Phase I to approximately 2 weeks

    Scored between 0-21:

    Cut offs:

    0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety

    Higher scores indicate greater symptom severity.

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

    Time frame: Start of Phase II to approximately 5 weeks

    Scored between 0-21:

    Cut offs:

    0-4 = None 5-9 = Mild anxiety 10-14 = Moderate anxiety 15-21 = Severe anxiety

    Higher scores indicate greater symptom severity.

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

    Time frame: Start of Phase I to approximately 2 weeks

    16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity

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

    Time frame: Start of Phase II to approximately 5 weeks

    16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity.

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

    Time frame: Start of Phase I to approximately 2 weeks

    24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.

  6. Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    24 item self-report measure. 19 questions are evaluated. Each item in the scale is rated between 0 (no distress) and 3 (serious distress). The total PSQI score ranges from 0-21. Sleep quality of the patients with a total score of 5 and below is considered "good". A score of greater than 5 refers to poor sleep quality.

  7. Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    11 item self-report measure measuring one's experiences as a healthcare professional and how they are feeling currently. Scored between 1-10. Higher scores indicate greater moral distress.

  8. Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    11 item self-report measuring one's experiences as a healthcare professional and how they are feeling currently. Scored between 1-10. Higher scores indicate greater moral distress.

  9. Change in score on the Modified Moral Injury Events Scale (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.

  10. Change in score on the Modified Moral Injury Events Scale (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    11 item self-report measure that measures moral injury. Statements related to distress or feelings of betrayal related to potentially morally injurious events are rated on a 6 point scale ranging from 1 (strongly agree) to 6 (strongly disagree). Score range is 11-66, with higher scores reflecting greater moral injury.

  11. Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

  12. Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

  13. Change in score on the Sheehan Disability Scale (SDS) (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

  14. Change in score on the Sheehan Disability Scale (SDS) (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    10 point visual analog scale to rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms. The 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).

  15. Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    The minimum score is 0 and the maximum score is 100. High score shows better result.

  16. Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    The minimum score is 0 and the maximum score is 100. High score shows better result.

  17. Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    5 items measuring one's social functioning on items covering ability to work, home management, social leisure activities, private leisure activities, and close relationships. Each item is scored between 0-8. Lower scores are better.

  18. Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    5 items measuring one's social functioning on items covering ability to work, home management, social leisure activities, private leisure activities, and close relationships. Each item is scored between 0-8. Lower scores are better.

  19. Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.

  20. Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    The scale is comprised of 140 items total. The measure is comprised of 14 different scales and respondents indicate on a 5-point scale the frequency of a stress-related event.

  21. Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.

  22. Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    12-item scale with a seven-point scale (from 1=strongly disagree to 7=strongly agree), resulting in a total score in the range of 12-84. Higher scores indicate higher perceived social support by Friends and Family/Significant Others.

  23. Change in score on the Posttraumatic Cognitions Inventory (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.

  24. Change in score on the Posttraumatic Cognitions Inventory (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    33-item self-report measure is designed to assess the degree to which a participant agrees with thoughts and beliefs that have been found to be common for individuals who suffer from PTSD. The measure is rated between 1 (Totally disagree) to 7 (Totally agree). The score range is 33-231. Higher scores indicate greater symptom severity.

  25. Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)

    Time frame: Start of Phase I to approximately 2 weeks

    The Difficulties in Emotion Regulation Scale-18 (DERS) is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.

  26. Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)

    Time frame: Start of Phase II to approximately 5 weeks

    The Difficulties in Emotion Regulation Scale-18 (DERS-18) is a 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.

  27. Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)

    Time frame: Start of Phase I to approximately 2 weeks

    The Pittsburgh Insomnia Rating Scale is a 20 item self report measure. Items are rated on a scale from 0-3. Higher scores indicate higher insomnia severity.

  28. Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)

    Time frame: Start of Phase II to approximately 5 weeks

    The Pittsburgh Insomnia Rating Scale is a 20 item self report measure. Items are rated on a scale from 0-3. Higher scores indicate higher insomnia severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Baryluk, BS

CONTACT

[email protected]

212-821-0783

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Nov 12, 2020
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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