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A Daily Coping Toolkit for Medical Personnel and First-Responders During COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398277
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Karin Coifman, Kent State University

Brief Summary:
During the current COVID-19 Pandemic, all communities are relying heavily on medical personnel and first-responders to maintain high levels of psychological and occupational functioning. However, during times of persistent high levels of stress, many individuals experience depletion in psychological resources, suffering intense distress that can make daily occupational and interpersonal functioning difficult. In order to assist with this immense challenge, this research team has developed a brief daily intervention based on decades of stress and trauma research that may help to support psychological health in individuals on the frontlines who are most essential to society. Considerable evidence supports the role of attention to and conceptualization of emotional experience in psychological resilience. This project tests a highly innovative combination of interventions targeting these processes in a brief, daily activity. The primary project aim is to investigate the Daily Coping Toolkit for medical personnel and first responders to determine efficacy over time, to test relative dosing, and to explicate the underlying therapeutic processes. The toolkit consists of 3 activities, administered one time each day, taking minutes to complete and will be administered to n=1000 personnel. Data analysis will test the impact of the toolkit on momentary affective processes and on symptoms and wellbeing over 9 months. The impact of this research will be evidence to support the further use of this novel tool to assist essential front-line personnel during this ongoing crisis helping to mitigate the psychological toll and also support occupational functioning now and in the future.

Condition or disease Intervention/treatment Phase
Psychological Stress Behavioral: Daily Coping Toolkit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: All participants receive the intervention. There is a brief randomized manipulation for dosage in the first 7 days only then all participants receive the higher dose.
Masking: Double (Participant, Investigator)
Masking Description: Participants are randomized to dose condition without their knowledge for the first 7 days. The primary investigator is blinded to conditions.
Primary Purpose: Supportive Care
Official Title: A Daily Coping Toolkit for Medical Personnel and First-Responders During the COVID-19 Pandemic
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Active Comparator: Initial Low dose
Participants will receive only one daily positive emotion prompt in the first seven days of the toolkit use.
Behavioral: Daily Coping Toolkit
  1. Emotion Labelling Activity: Participants rate 10 discrete negative and positive emotional words on a likert scale (0-4).
  2. Expressive Writing and Self Distancing Activity: Participants respond to an open-ended prompt to write about their day in an open text box in response to the prompt: "What was today like for you?" After this is completed, they are prompted that if the experience was very challenging, to revisit that experience in their mind by taking a "fly on the wall" perspective (Kross & Ayduk, 2016).
  3. Positive Emotion Generation Activity (1 v. 2 prompts) Participants are prompted to take a deep breath and then respond to 1 (or 2) of 8 possible prompts in which they can generate positive emotions. In response to each, they are asked to describe their thoughts or memories in open-ended text box.

Active Comparator: Initial high dose
Participants will receive two daily positive emotion prompts in the first seven days of use.
Behavioral: Daily Coping Toolkit
  1. Emotion Labelling Activity: Participants rate 10 discrete negative and positive emotional words on a likert scale (0-4).
  2. Expressive Writing and Self Distancing Activity: Participants respond to an open-ended prompt to write about their day in an open text box in response to the prompt: "What was today like for you?" After this is completed, they are prompted that if the experience was very challenging, to revisit that experience in their mind by taking a "fly on the wall" perspective (Kross & Ayduk, 2016).
  3. Positive Emotion Generation Activity (1 v. 2 prompts) Participants are prompted to take a deep breath and then respond to 1 (or 2) of 8 possible prompts in which they can generate positive emotions. In response to each, they are asked to describe their thoughts or memories in open-ended text box.




Primary Outcome Measures :
  1. Patient Health Questionnaire - 4 [ Time Frame: 1 week ]
    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

  2. Patient Health Questionnaire - 4 [ Time Frame: 9 weeks ]
    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

  3. Patient Health Questionnaire - 4 [ Time Frame: 26 weeks ]
    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

  4. Patient Health Questionnaire - 4 [ Time Frame: 40 weeks ]
    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams & Lowe, 2009

  5. World Health Organization Well Being Questionnaire [ Time Frame: 1 week ]
    2 items from the WHO-5: Beck 2004

  6. World Health Organization Well Being Questionnaire [ Time Frame: 9 weeks ]
    2 items from the WHO-5: Beck 2004

  7. World Health Organization Well Being Questionnaire [ Time Frame: 26 weeks ]
    2 items from the WHO-5: Beck 2004

  8. World Health Organization Well Being Questionnaire [ Time Frame: 40 weeks ]
    2 items from the WHO-5: Beck 2004

  9. Affective Experience [ Time Frame: 1 week ]
    Reported negative and positive emotions: Coifman et al, 2016

  10. Treatment Acceptability Questionnaire [ Time Frame: 1 week ]
    Adapted from Hunsley, 1992, assessed subjective experience with intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Active Medical Personnel or First-Responders working during the COVID-19 Pandemic -

Exclusion Criteria: NONE

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398277


Contacts
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Contact: Karin Coifman, PhD 13306729155 kcoifman@kent.edu

Locations
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United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44313
Contact: Sarah Delahanty, PhD       sdelahanty@akronchildrens.org   
Summa Health Systems Recruiting
Akron, Ohio, United States, 44313
Contact: Patrick Palmieri, PhD       pamierp@summahealth.org   
Kent State University Recruiting
Kent, Ohio, United States, 44242
Contact: Karin Coifman, PhD    330-672-9155    kcoifman@kent.edu   
Contact: David Disabato, PhD    330-672-2184    ddisabat@kent.edu   
Sub-Investigator: Stanley Seah, MA         
Sponsors and Collaborators
Kent State University
Investigators
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Principal Investigator: Doug Delahanty, PhD Kent State University
Principal Investigator: John Gunstad, PhD Kent State University
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Responsible Party: Karin Coifman, Associate Professor, Psychological Sciences, Kent State University
ClinicalTrials.gov Identifier: NCT04398277    
Other Study ID Numbers: 20-183
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data and materials will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after data collection is complete
Access Criteria: Contact the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karin Coifman, Kent State University:
COVID-19 Pandemic
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms