Clinical trial NCT04626050: General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19
Official title: A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD and Co-Morbidities in Healthcare Workers Consequent to the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Moral Injury
Keywords: PTSD
Moral Injury
Psychological Distress
Healthcare Workers
COVID-19
COVID-19 Pandemic
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Feasibility Indicator: Recruitment (Phase I)
timeFrame: Baseline
measure: Feasibility Indicator: Recruitment (Phase II)
timeFrame: Post-Phase I Assessment at week 2
measure: Feasibility Indicator: Enrollment (Phase I)
timeFrame: Baseline
measure: Feasibility Indicator: Enrollment (Phase II)
timeFrame: Post-Phase I Assessment at approximately week 2
measure: Feasibility Indicator: Retention (Phase I)
timeFrame: Post-Phase I Assessment at approximately week 2
measure: Feasibility Indicator: Retention (Phase II)
timeFrame: Post-Phase II Assessment at approximately week 7
measure: Acceptability Indicator: Satisfaction (Phase I)
timeFrame: Post-Phase I Assessment at approximately week 2
measure: Acceptability Indicator: Satisfaction (Phase II)
timeFrame: Post-Phase II Assessment at approximately week 7
measure: Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
Secondary outcomes:
measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Modified Moral Injury Events Scale (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Modified Moral Injury Events Scale (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Sheehan Disability Scale (SDS) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Sheehan Disability Scale (SDS) (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Posttraumatic Cognitions Inventory (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Posttraumatic Cognitions Inventory (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)
timeFrame: Start of Phase II to approximately 5 weeks
measure: Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
timeFrame: Start of Phase I to approximately 2 weeks
measure: Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
timeFrame: Start of Phase II to approximately 5 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: JoAnn Difede, PhD
role: PRINCIPAL_INVESTIGATOR
References: