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General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

Primary Purpose

Post-traumatic Stress Disorder, Moral Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Music
Narrative Writing
Prolonged Exposure Therapy
Interpersonal Psychotherapy
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, Moral Injury, Psychological Distress, Healthcare Workers, COVID-19, COVID-19 Pandemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Medical Music (Phase I)

Narrative Writing (Phase I)

Interpersonal Psychotherapy (Phase II)

Prolonged Exposure Therapy (Phase II)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Feasibility Indicator: Recruitment (Phase I)
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Recruitment (Phase II)
Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment (Phase I)
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Enrollment (Phase II)
Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Feasibility Indicator: Retention (Phase I)
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.
Feasibility Indicator: Retention (Phase II)
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.
Acceptability Indicator: Satisfaction (Phase I)
Acceptability and treatment satisfaction will be rated with a Likert scale.
Acceptability Indicator: Satisfaction (Phase II)
Acceptability and treatment satisfaction will be rated with a Likert scale.
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)
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 Outcome Measures

Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)
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.
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)
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.
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)
16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)
16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity.
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)
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.
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)
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.
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)
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.
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)
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.
Change in score on the Modified Moral Injury Events Scale (Phase I)
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.
Change in score on the Modified Moral Injury Events Scale (Phase II)
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.
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Change in score on the Sheehan Disability Scale (SDS) (Phase I)
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).
Change in score on the Sheehan Disability Scale (SDS) (Phase II)
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).
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)
The minimum score is 0 and the maximum score is 100. High score shows better result.
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)
The minimum score is 0 and the maximum score is 100. High score shows better result.
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)
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.
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)
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.
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)
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.
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)
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.
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)
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.
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)
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.
Change in score on the Posttraumatic Cognitions Inventory (Phase I)
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.
Change in score on the Posttraumatic Cognitions Inventory (Phase II)
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.
Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)
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.
Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)
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.
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
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.
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
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.

Full Information

First Posted
November 10, 2020
Last Updated
September 25, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04626050
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder, Moral Injury
Keywords
PTSD, Moral Injury, Psychological Distress, Healthcare Workers, COVID-19, COVID-19 Pandemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not be aware of the condition for Phase 1 or Phase 2 of the study.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical Music (Phase I)
Arm Type
Experimental
Arm Description
Participants will complete four medical music sessions that are 20 minutes in length each.
Arm Title
Narrative Writing (Phase I)
Arm Type
Experimental
Arm Description
Participants will complete four narrative writing sessions that are 20 minutes in length each.
Arm Title
Interpersonal Psychotherapy (Phase II)
Arm Type
Active Comparator
Arm Description
IPT is comprised of ten 75-minute sessions scheduled twice weekly.
Arm Title
Prolonged Exposure Therapy (Phase II)
Arm Type
Active Comparator
Arm Description
ET is comprised of ten 75-minute sessions scheduled twice weekly.
Intervention Type
Behavioral
Intervention Name(s)
Medical Music
Intervention Description
Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Narrative Writing
Intervention Description
Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
Psychotherapy including imaginal exposure for PTSD
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning
Primary Outcome Measure Information:
Title
Feasibility Indicator: Recruitment (Phase I)
Description
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Time Frame
Baseline
Title
Feasibility Indicator: Recruitment (Phase II)
Description
Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Time Frame
Post-Phase I Assessment at week 2
Title
Feasibility Indicator: Enrollment (Phase I)
Description
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Time Frame
Baseline
Title
Feasibility Indicator: Enrollment (Phase II)
Description
Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Time Frame
Post-Phase I Assessment at approximately week 2
Title
Feasibility Indicator: Retention (Phase I)
Description
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.
Time Frame
Post-Phase I Assessment at approximately week 2
Title
Feasibility Indicator: Retention (Phase II)
Description
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.
Time Frame
Post-Phase II Assessment at approximately week 7
Title
Acceptability Indicator: Satisfaction (Phase I)
Description
Acceptability and treatment satisfaction will be rated with a Likert scale.
Time Frame
Post-Phase I Assessment at approximately week 2
Title
Acceptability Indicator: Satisfaction (Phase II)
Description
Acceptability and treatment satisfaction will be rated with a Likert scale.
Time Frame
Post-Phase II Assessment at approximately week 7
Title
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)
Description
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)
Description
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Time Frame
Start of Phase II to approximately 5 weeks
Secondary Outcome Measure Information:
Title
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)
Description
16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)
Description
16-item self-report measure. Scored between 0-3. Higher scores indicate greater symptom severity.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Modified Moral Injury Events Scale (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Modified Moral Injury Events Scale (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)
Description
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)
Description
The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Sheehan Disability Scale (SDS) (Phase I)
Description
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).
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Sheehan Disability Scale (SDS) (Phase II)
Description
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).
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)
Description
The minimum score is 0 and the maximum score is 100. High score shows better result.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)
Description
The minimum score is 0 and the maximum score is 100. High score shows better result.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Posttraumatic Cognitions Inventory (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Posttraumatic Cognitions Inventory (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks
Title
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
Description
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.
Time Frame
Start of Phase I to approximately 2 weeks
Title
Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)
Description
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.
Time Frame
Start of Phase II to approximately 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Baryluk, BS
Phone
212-821-0783
Email
olb4002@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnn Difede, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Baryluk, BS
First Name & Middle Initial & Last Name & Degree
JoAnn Difede, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

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