Recruiting

COPING CREW

Sponsor:

Ohio University

Code:

NCT05019053

Conditions

Social Isolation

Emotional Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coping Crew

Study Details

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

Study ID

NCT05019053

Start date

Sep 1, 2021

Status verified date

Feb, 2022

Completion date

May 31, 2022

Anticipated

Primary completion date

May 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coping Crew Intervention

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.

Interventions

Coping Crew

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.

Primary outcome measure

  • Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8 [ Time Frame: Immediately after the intervention ]
  • Feasibility of service as assessed by response rates for the Ecological Momentary Assessment/Ecological Momentary Intervention component of the intervention [ Time Frame: 5-week EMA/EMI, During the Intervention (Weeks 1-5) ]

Central Contacts and Locations

Central contacts

Nicholas Allan, Ph.D.

740-597-2717allan@ohio.edu

Catherine Accorso, M.A.

5853301188ca265518@ohio.edu

Locations

Ohio University

Recruiting

Athens, Ohio, United States, 45701

More Information

Sponsor

Ohio University

Last update posted

Feb 18, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio University on 2022-02-18.