Acceptability/Feasibility of COVID-19 Intervention

NCT05019053 | Unknown

• 1 other identifier: BAKER_Coping Crew Intervention
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The coronavirus (COVID-19) pandemic is a significant psychological stressor that threatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19 and its economic impact, as well as loneliness due to the required social isolation, are driving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll, 45% of respondents reported that the coronavirus has had a negative impact on their mental health. This is reflected in Southeastern Ohio. In data that the investigators collected from 317 Ohio University faculty, staff, and students from late May to early June, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severe levels of depression and 57% reported the COVID-19 outbreak was impacting their sense of social connection much or very much. Despite the significant community need for accessible and affordable care, there are currently no evidence-based interventions for individuals coping poorly with coronavirus-related distress. The investigators have developed a virtual group-based intervention targeting cognitive biases that amplify the experience of stress and anxiety (i.e., amplifying cognitions; Coping with Coronavirus-Related Emotion and Worry \[COPING CREW\]). The next step in developing this intervention in a scientifically rigorous manner is to refine the manual and procedures and conduct a pilot test of the intervention.

Conditions

Social Isolation; Emotional Disorder

Outcome Measures

Primary Outcomes (2)

• Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8

  The Client Satisfaction Questionnaire-8 is a 8-item self-report scale that assesses client satisfaction with a particular intervention/program. The Client Satisfaction Questionnaire-8 is completed by rating satisfaction with services on a 1-4 Likert-type scale. Possible total scores range from 8 to 32. Greater satisfaction is indicated by higher scores.

  Immediately after the intervention

• Feasibility of service as assessed by response rates for the Ecological Momentary Assessment/Ecological Momentary Intervention component of the intervention

  Feasibility will also be determined based on response rates for Ecological Momentary Assessment/Ecological Momentary Intervention. If 80% of participants respond to 80% of the EMA prompts, this will be considered a feasible means of service delivery.

  5-week EMA/EMI, During the Intervention (Weeks 1-5)

Secondary Outcomes (65)

• COVID-19 Impact Battery - Behavior

  Baseline, pre-intervention

• COVID-19 Impact Battery - Behavior

  Immediately after the intervention

• COVID-19 Impact Battery - Behavior

  Follow-Up, 1 month after the intervention

• COVID-19 Impact Battery - Behavior

  Follow-Up, 3 months after the intervention

• COVID-19 Impact Battery - Worry

  Baseline, pre-intervention

Study Arms (1)

Coping Crew Intervention

EXPERIMENTAL

Interested participants who meet the screening criteria will be assigned to receive COPING CREW. First, following informed consent, eligible participants will complete a baseline assessment appointment in the week prior to the group beginning. During the baseline appointment, participants will provide informed consent, be instructed in the use of Microsoft Teams, complete a battery of self-report measures, be given a semi-structured diagnostic interview, and follow instructions to install a mobile app that will be used to track their mood and homework. Then, 4 groups of COPING CREW, with 6 participants per group, will be run. Participants will complete four weekly 60-minute virtual intervention sessions followed by a booster session two weeks later. Participants will complete daily surveys and homework assignments on their mobile devices. Links to follow-up surveys will be sent to participants at 1- and 3-month follow-ups.

Behavioral: Coping Crew

Interventions

Coping Crew BEHAVIORAL

Coping Crew consists of five 60-minute virtual intervention sessions coinciding with five weeks of EMI. Participants will receive psychoeducation, challenge cognitive biases or mythbust, and participate in behavioral exposure and behavioral experiments. An EMI component of this treatment will be included for the purpose of treatment monitoring and homework tracking. Participation in this EMI component involves the daily report of levels of anxiety, depression, stress, and loneliness. When participants endorse elevated levels on any of these constructs, they will receive a targeted message reminding them of the topics covered in COPING CREW. One month after the intervention session, COPING CREW participants will complete follow-up questionnaires and interview. Participants will also participate in a feedback session 3 months after the intervention.

Coping Crew Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elevated anxiety sensitivity (i.e., a score greater than 1 standard deviation above the mean on the Anxiety Sensitivity Index-3; Taylor et al., 2007)
• Elevated Intolerance of uncertainty (i.e., a score greater than 1 standard deviation above the mean on the Intolerance of Uncertainty Scale - Short Form; Carleton et al., 2007)
• Elevated loneliness (i.e., a score greater than 1 standard deviation above the mean on the NIH Toolbox Loneliness Scale; Cyranowski et al., 2013)
• Access to a device with internet connection

You may not qualify if:

• Participants who have previously received other FEAR Lab interventions or participated in a focus group related to that intervention (20-X-184; 20-X-204) will be excluded due to the overlap of intervention material.

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Nicholas Allan, Ph.D.

CONTACT

740-597-2717; allan@ohio.edu

Catherine Accorso, M.A.

CONTACT

5853301188; ca265518@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychology

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 24, 2021
• Study Start: September 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)