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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States3 sites, 3 recruiting
- 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
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).
- 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
- 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.
- 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.
- Conditions
- Psychological Stress
- 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
- Emotion Labelling Activity: Participants rate 10 discrete negative and positive emotional words on a likert scale (0-4).
- 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).
- 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 group | Role | What they receive |
|---|---|---|
| Initial Low dose | Active comparator | Participants will receive only one daily positive emotion prompt in the first seven days of the toolkit use. Receives: Behavioral: Daily Coping Toolkit |
| Initial high dose | Active comparator | Participants 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.
Patient Health Questionnaire - 4
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Measured: 1 week
Patient Health Questionnaire - 4
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Measured: 9 weeks
Patient Health Questionnaire - 4
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Measured: 26 weeks
Patient Health Questionnaire - 4
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Measured: 40 weeks
World Health Organization Well Being Questionnaire
2 items from the WHO-5: Beck 2004
Measured: 1 week
World Health Organization Well Being Questionnaire
2 items from the WHO-5: Beck 2004
Measured: 9 weeks
World Health Organization Well Being Questionnaire
2 items from the WHO-5: Beck 2004
Measured: 26 weeks
World Health Organization Well Being Questionnaire
2 items from the WHO-5: Beck 2004
Measured: 40 weeks
Affective Experience
Reported negative and positive emotions: Coifman et al, 2016
Measured: 1 week
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.
- First posted21 May 2020
- Study start1 May 2020
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Coifman, Kent State University
- Investigators
- Doug Delahanty, PhD, Principal investigator, Kent State UniversityJohn Gunstad, PhD, Principal investigator, Kent State University
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.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Daily Coping Toolkit for Medical Personnel and First-Responders During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04398277
- Acronym / sponsor ID
- 20-183
- Conditions
- Psychological Stress
- Keywords
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- 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
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Initial Low dose | Active comparator | Behavioral: Daily Coping ToolkitParticipants will receive only one daily positive emotion prompt in the first seven days of the toolkit use. |
| Initial high dose | Active comparator | Behavioral: Daily Coping ToolkitParticipants will receive two daily positive emotion prompts in the first seven days of use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Coping Toolkit1. 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. | Behavioural | Initial Low dose, Initial high dose |
Primary outcome
Patient Health Questionnaire - 4
Time frame: 1 week
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Patient Health Questionnaire - 4
Time frame: 9 weeks
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Patient Health Questionnaire - 4
Time frame: 26 weeks
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
Patient Health Questionnaire - 4
Time frame: 40 weeks
Patient Health Questionnaire 4 items, Kroenke, Spitzer, Williams \& Lowe, 2009
World Health Organization Well Being Questionnaire
Time frame: 1 week
2 items from the WHO-5: Beck 2004
World Health Organization Well Being Questionnaire
Time frame: 9 weeks
2 items from the WHO-5: Beck 2004
World Health Organization Well Being Questionnaire
Time frame: 26 weeks
2 items from the WHO-5: Beck 2004
World Health Organization Well Being Questionnaire
Time frame: 40 weeks
2 items from the WHO-5: Beck 2004
Affective Experience
Time frame: 1 week
Reported negative and positive emotions: Coifman et al, 2016
Treatment Acceptability Questionnaire
Time frame: 1 week
Adapted from Hunsley, 1992, assessed subjective experience with intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Yes. All data and materials will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Delahanty, PhD principal investigator
Kent State University
John Gunstad, PhD principal investigator
Kent State University
3 sites in 1 country: see every site and its status.
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.