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 thatthreatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19and its economic impact, as well as loneliness due to the required social isolation, aredriving 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 theirmental health. This is reflected in Southeastern Ohio. In data that the investigatorscollected from 317 Ohio University faculty, staff, and students from late May to earlyJune, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severelevels of depression and 57% reported the COVID-19 outbreak was impacting their sense ofsocial connection much or very much. Despite the significant community need foraccessible and affordable care, there are currently no evidence-based interventions forindividuals coping poorly with coronavirus-related distress. The investigators havedeveloped a virtual group-based intervention targeting cognitive biases that amplify theexperience of stress and anxiety (i.e., amplifying cognitions; Coping withCoronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing thisintervention in a scientifically rigorous manner is to refine the manual and proceduresand 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.

Unknown status
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