NCT04398277

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 20, 2020

Last Update Submit

May 20, 2020

Conditions

Psychological Stress

Keywords

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (10)

  • Patient Health Questionnaire - 4

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

    1 week

  • Patient Health Questionnaire - 4

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

    9 weeks

  • Patient Health Questionnaire - 4

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

    26 weeks

  • Patient Health Questionnaire - 4

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

    40 weeks

  • World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    1 week

  • World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    9 weeks

  • World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    26 weeks

  • World Health Organization Well Being Questionnaire

    2 items from the WHO-5: Beck 2004

    40 weeks

  • Affective Experience

    Reported negative and positive emotions: Coifman et al, 2016

    1 week

  • Treatment Acceptability Questionnaire

    Adapted from Hunsley, 1992, assessed subjective experience with intervention

    1 week

Study Arms (2)

Initial Low dose

ACTIVE COMPARATOR

Participants will receive only one daily positive emotion prompt in the first seven days of the toolkit use.

Behavioral: Daily Coping Toolkit

Initial high dose

ACTIVE COMPARATOR

Participants will receive two daily positive emotion prompts in the first seven days of use.

Behavioral: Daily Coping Toolkit

Interventions

Daily Coping ToolkitBEHAVIORAL

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.

Initial Low doseInitial high dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Akron Children's Hospital

Akron, Ohio, 44313, United States

RECRUITING

Summa Health Systems

Akron, Ohio, 44313, United States

RECRUITING

Kent State University

Kent, Ohio, 44242, United States

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalCOVID-19

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Doug Delahanty, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

  • John Gunstad, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Coifman, PhD

CONTACT

13306729155kcoifman@kent.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants are randomized to dose condition without their knowledge for the first 7 days. The primary investigator is blinded to conditions.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Psychological Sciences

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 21, 2020

Study Start

May 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

All data and materials will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12 months after data collection is complete
Access Criteria
Contact the PI

Locations

US(3)