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Recruiting NCT04626050

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

No phase Interventional Post-traumatic Stress Disorder Moral Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medical Music, Narrative Writing, Prolonged Exposure Therapy, Interpersonal Psychotherapy.
Who it may be relevant to
Registry conditions: Post-traumatic Stress Disorder, Moral Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Medical Music
    Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
  • Behavioral Narrative Writing
    Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
  • Behavioral Prolonged Exposure Therapy
    Psychotherapy including imaginal exposure for PTSD
  • Behavioral Interpersonal Psychotherapy
    Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • 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]
  • Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I) [Time frame: Start of Phase I to approximately 2 weeks]
  • Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II) [Time frame: Start of Phase II to approximately 5 weeks]
  • Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I) [Time frame: Start of Phase I to approximately 2 weeks]
  • Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II) [Time frame: Start of Phase II to approximately 5 weeks]
  • Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I) [Time frame: Start of Phase I to approximately 2 weeks]
  • Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II) [Time frame: Start of Phase II to approximately 5 weeks]
  • Change in score on the Modified Moral Injury Events Scale (Phase I) [Time frame: Start of Phase I to approximately 2 weeks]
  • Change in score on the Modified Moral Injury Events Scale (Phase II) [Time frame: Start of Phase II to approximately 5 weeks]
  • Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I) [Time frame: Start of Phase I to approximately 2 weeks]
  • Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II) [Time frame: Start of Phase II to approximately 5 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Publications

  • 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 37585569

Identifiers

NCT: NCT04626050 · 20-04021913

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗