Official Title
Acceptability/Feasibility of COVID-19 Intervention of a Virtual Group Intervention for COVID-19 Distress
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.

Detailed Description

There is a coming mental health crisis in response to the COVID-19 pandemic. Already, rates
of depression, anxiety, and suicide are elevated in response to the pandemic. A recent study
of more than 5,400 people in the US found prevalence rates of anxiety and depression in June
of 2020 were 3-4 times higher than these rates in June of 2019. In this same study, 41% of
respondents in June 2020 reported experiencing an adverse mental or behavioral health
condition, including 13% who endorsed using substances to cope with stress or emotions and
11% who reported seriously contemplating suicide in the prior 30 days. Thus, heightened
anxiety, stress, and depression will likely continue to lead to increases in self-harm and
maladaptive substance use if left unchecked.

It is crucial that empirically validated psychotherapies be developed to meet these needs.
These treatments must address how common barriers to treatment, including time, cost,
transportation, and stigma about mental health may be exacerbated by the pandemic. The
investigators developed a brief, virtual group-based intervention, framed as educational,
Coping with Coronavirus-Related Emotions and Worries (COPING CREW), to address these
barriers. This intervention was developed over the summer by Drs. Allan, Suhr, and Austin,
working with two graduate student research assistants for administration by clinical
psychology graduate student therapists as part of their practicum experience at the Ohio
University Psychology and Social Work Clinic (PSWC). A benefit of this approach, therefore,
is that this intervention is highly scalable.

Theoretical models posit the short- and long-term stressors experienced during the pandemic
exacerbate the experience of negative emotions an individual is already predisposed to
experience. That is, people who are already experiencing mental health issues are going to
experience more severe issues and people who may not already be experiencing mental health
issues are more likely to develop mental health issues during the pandemic. Cognitive risk
factors (i.e., amplifying cognitions) such as anxiety sensitivity (fear of anxiety
sensations), intolerance of uncertainty (fear of the unknown), and loneliness (the subjective
feeling of isolation) increase the experience of negative emotions as well as the likelihood
of unhealthy coping behavior such as increased alcohol consumption or self-harm.

Anxiety sensitivity, intolerance of uncertainty, and loneliness can be reduced through brief
interventions applying cognitive-behavioral therapy principles. Reductions in these
constructs lead to later reductions in anxiety, depression, and suicide. Targeting these risk
factors appears critical to address distress due to COVID-19. In 317 Ohio University faculty,
staff, and students, anxiety sensitivity, intolerance of uncertainty, and loneliness
accounted for 63%-75% of the variance in ratings of anxiety, depression, and suicidality as
well as 49% of COVID-related disability. These findings highlight the prominent role these
risk factors play in the distress many individuals are experiencing due to COVID-19. The
investigators have developed a virtual group-based intervention targeting risk factors that
amplify the experience of emotional distress; the next steps in developing a scientifically
rigorous intervention that can be disseminated broadly is to develop and pilot test this
intervention.

The goals specific to this project are to 1) engage stakeholders in the design of a brief
group-based treatment to improve COPING CREW and 2) to conduct a Stage I pilot trial through
evaluating the acceptability and feasibility of COPING CREW.

Aim 1: Refine a prototype for COPING CREW by working virtually with a community partner
stakeholder advisory group (SAG) as well as participants receiving the intervention. The
investigators will develop a SAG comprising one participant from each community partner. The
investigators will meet with the SAG at least three times during the 1-year project. Meetings
will occur prior to starting COPING CREW groups, after running the first two groups, and
after all four groups have been completed. The investigators anticipate that building a
strong relationship with this SAG will increase treatment relevance to clientele, treatment
engagement, and treatment dissemination. In turn, this will enhance the durable impacts and
sustainability of COPING CREW. In addition to SAGs, the investigators will also utilize a
systematic approach to engage with participant stakeholders by asking for feedback about the
intervention (the Exit Interview). The investigators have used these intervention modules
separately a number of times but have yet to examine these modules as part of the same
intervention. Thus, participants will provide important information on how to tailor the
intervention, including the order of the components, the amount of homework specific to each
component, and the length of time before the booster session to best meet their needs.
Although the investigators are confident that COPING CREW will largely be viewed as
acceptable, it can be modified to increase acceptability by effective engagement with
community partners. Solicitation of feedback will occur via two mechanisms. First,
information related to adaptation will be obtained from quantitative and qualitative feedback
during the intervention. Second, information related to adaptation and engagement will also
be collected in separate, focused feedback sessions with COPING CREW participants.

Aim 2: Examine acceptability and feasibility of COPING CREW, delivered virtually. A pilot one
arm trial will be conducted, delivering the intervention to 24 participants across 4 groups.

H1: It is hypothesized that the intervention will demonstrate high acceptability and
feasibility (as measured by completion rates and favorable ratings of satisfaction) across
intervention modules and components within sessions. Components will include psychoeducation,
challenging cognitive biases or mythbusting, behavioral exposure, behavioral experiments, and
ecological momentary intervention (EMI) for treatment monitoring and homework tracking.

Recruiting
Social Isolation
Emotional Disorder

Behavioral: 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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Ohio University
Athens, Ohio, United States

Investigator: Nicholas P Allan, Ph.D

Contacts

Nicholas Allan, Ph.D.
740-597-2717
allan@ohio.edu

Catherine Accorso, M.A.
5853301188
ca265518@ohio.edu

Ohio University
NCT Number
MeSH Terms
COVID-19