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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I) [Срок оценки: Start of Phase I to approximately 2 weeks]
• Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II) [Срок оценки: Start of Phase II to approximately 5 weeks]
• Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I) [Срок оценки: Start of Phase I to approximately 2 weeks]
• Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II) [Срок оценки: Start of Phase II to approximately 5 weeks]
• Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I) [Срок оценки: Start of Phase I to approximately 2 weeks]
• Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II) [Срок оценки: Start of Phase II to approximately 5 weeks]
• Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I) [Срок оценки: Start of Phase I to approximately 2 weeks]
• Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II) [Срок оценки: Start of Phase II to approximately 5 weeks]
• Change in score on the Modified Moral Injury Events Scale (Phase I) [Срок оценки: Start of Phase I to approximately 2 weeks]
• Change in score on the Modified Moral Injury Events Scale (Phase II) [Срок оценки: Start of Phase II to approximately 5 weeks]
• Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I) [Срок оценки: Start of Phase I to approximately 2 weeks]
• Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II) [Срок оценки: Start of Phase II to approximately 5 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Публикации

• 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

Идентификаторы

NCT: NCT04626050 · 20-04021913

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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