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Psychological StressNCT04398277

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

A study testing Daily Coping Toolkit in people with Psychological Stress, run by Kent State University at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological Stress
What is being tested?
Daily Coping Toolkit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
3 sitesUnited States
Study dates
1 May 2020to Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

3 sites in 1 country.

Karin Coifman, PhD contact

13306729155

kcoifman@kent.edu

United States3 sites, 3 recruiting
  • Akron Children's Hospital

    Akron, Ohio, 44313

    Sarah Delahanty, PhD, sdelahanty@akronchildrens.org

    Recruiting
  • Summa Health Systems

    Akron, Ohio, 44313

    Patrick Palmieri, PhD, pamierp@summahealth.org

    Recruiting
  • Kent State University

    Kent, Ohio, 44242

    Karin Coifman, PhD, 330-672-9155, kcoifman@kent.edu

    David Disabato, PhD, 330-672-2184, ddisabat@kent.edu

    Recruiting

Other trials in United States

About this study

Official title: A Daily Coping Toolkit for Medical Personnel and First-Responders During the COVID-19 Pandemic

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.

Read the detailed description

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 during this exceptionally challenging crisis, this research team has developed a brief daily intervention based on decades of stress and trauma research that may help to support psychological health and coping resources in individuals on the frontlines: medical personnel and first-responders. These are individuals who are most essential to society in this difficult time. Although hospitals, fire, and police departments have existing support resources in place, they are either based on traditional models of treatment or consist of online peer-support or wellness applications. All facets of existing support/interventions have considerable utility, but it is not clear that these resources are designed to address the frequent and ongoing coping demands of this crisis across a broad swath of individuals. In particular, traditional psychotherapy models are unlikely to be successful due to very real time constraints of this population at this time. Moreover, several decades of research would argue that traditional psychotherapy is unlikely to be needed by most individuals, given prototypical patterns of adjustment across a range of aversive events, including prior pandemics (SARS: Bonanno, et al 2008). However, even resilient individuals will struggle with distress and some symptoms. Prior research has suggested that specific emotion processing patterns can support resilient outcomes over the long-term and thus frontline workers may benefit from an intervention that leverages this existing knowledge to facilitate adaptive emotion regulatory processing and elevate well-being during this crisis.

The proposed project aims to investigate a novel intervention: A Daily Coping Toolkit, administered via online application, that consists of 3 activities targeting adaptive emotional attention and expression, administered one time each day, only 4-10 minutes in duration daily. The Toolkit is both practically feasible given the demands and current burden on the target population as well as highly consistent with existing evidence. Moreover, the Toolkit is not likely to conflict with other online tools or with traditional psychotherapy and hence, can be practically applied across a broad swath of individuals in need. The primary project aim is to test the Daily Coping Toolkit on a broader population of medical personnel and first responders to determine efficacy over time, to test relative dosing, and to explicate the underlying therapeutic processes. The potential 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. This may assist with mitigating the psychological toll of this crisis and also support the occupational functioning of medical personnel and first responders, thus, contributing indirectly to improved patient outcomes. Finally, knowledge gained from this research will support the further development of this tool to support individuals facing future challenging events and circumstances.

Participants: n=1000 medical personnel and first responders to test the efficacy of the Daily Coping Toolkit.

Procedure: Interested individuals will go to www.tinyurl.com/dailycopingtoolkit for additional information, including the informed consent. Once consent is provided, individuals complete a brief assessment of current symptoms, well-being and psychiatric/treatment history and then receive instructions to download the research application ExpiWell (www.expiwell.com) a secure platform that operates on ios/Android devices upon which we administer the Toolkit. Once downloaded, participants are randomized to a high versus low treatment condition and will receive daily prompts to complete the intervention. After 7 days, they complete a brief assessment of symptoms, well-being, and acceptability of the intervention and consent again for continuation in the research. Individuals can continue to use the application without consenting further if they choose and their data will not be accessible to researchers. For those that do consent, follow-up assessments occur at 2,6, and 9 months (symptoms and well-being).

Daily Coping Toolkit Intervention: Participants are prompted one time daily (with 1-2 reminders) to complete the intervention which consists of the following three parts. Randomization to high versus low condition is maintained for the first 7 days only in order to test for relative dose effects (see #3 below).

  1. Emotion Labelling Activity: Participants rate 10 discrete negative and positive emotional words on a likert scale (0-4). Precise labelling of emotional experience can serve as a form of implicit emotion regulation and has been associated with healthy psychophysiological and behavioral adaptation in a range of community and clinical samples
  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...?" 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; see figure for instructions). Persistent evidence has indicated that expressive writing is an effective coping tool. In addition, research has identified the ways in which specific word use can facilitate healthy emotional processing during stress. There is also significant research demonstrating that shifting perspective about negative emotional experiences can facilitate a healthier distance from it.
  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. Note: For the first 7 days, participants are randomized to either respond to one (low dose) or two (high dose) prompts so as to test the relative efficacy of the "dose". After 8 days, all participants default to the higher dose of 2 prompts. Prompts are designed to elicit gratitude, positive social experiences, amusing memories, kind acts they committed, satisfaction/pride with accomplishments, positive future focus, and love for close others. Prior research has demonstrated that positive emotions generated during highly stressful events predict resilience and improved emotion regulation and coping. Moreover, positive emotion generation has been shown broadly to predict increased psychological wellbeing.
Being tested
Daily Coping Toolkit
Keywords
COVID-19 Pandemic
Medical subject headings
Stress, Psychological, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Coping ToolkitBehavioural

    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.
Study groups in NCT04398277
Study groupRoleWhat they receive
Initial Low doseActive comparatorParticipants will receive only one daily positive emotion prompt in the first seven days of the toolkit use.
Receives: Behavioral: Daily Coping Toolkit
Initial high doseActive comparatorParticipants will receive two daily positive emotion prompts in the first seven days of use.
Receives: Behavioral: Daily Coping Toolkit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Health Questionnaire - 4

    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009

    Measured: 1 week

  2. Patient Health Questionnaire - 4

    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009

    Measured: 9 weeks

  3. Patient Health Questionnaire - 4

    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009

    Measured: 26 weeks

  4. Patient Health Questionnaire - 4

    Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009

    Measured: 40 weeks

  5. World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    Measured: 1 week

  6. World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    Measured: 9 weeks

  7. World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    Measured: 26 weeks

  8. World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    Measured: 40 weeks

  9. Affective Experience

    Reported negative and positive emotions: Coifman et al, 2016

    Measured: 1 week

  10. Treatment Acceptability Questionnaire

    Adapted from Hunsley, 1992, assessed subjective experience with intervention

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start1 May 2020
  3. Primary completionApr 2021 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
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 blind
Who is masked
Participant, Investigator
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398277
Sponsor's protocol ID
20-183
Status last verified
May 2020
First submitted
20 May 2020
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data and materials will be made available.

Questions about this trial

What is this clinical trial studying?

A study testing Daily Coping Toolkit in people with Psychological Stress, run by Kent State University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karin Coifman, PhD (13306729155, kcoifman@kent.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire - 4 (time frame: 1 week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.

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