Clinical trial NCT05019053: Acceptability/Feasibility of COVID-19 Intervention
Official title: Acceptability/Feasibility of COVID-19 Intervention of a Virtual Group Intervention for COVID-19 Distress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Social Isolation
Emotional Disorder
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8
timeFrame: Immediately after the intervention
measure: Feasibility of service as assessed by response rates for the Ecological Momentary Assessment/Ecological Momentary Intervention component of the intervention
timeFrame: 5-week EMA/EMI, During the Intervention (Weeks 1-5)
Secondary outcomes:
measure: COVID-19 Impact Battery - Behavior
timeFrame: Baseline, pre-intervention
measure: COVID-19 Impact Battery - Behavior
timeFrame: Immediately after the intervention
measure: COVID-19 Impact Battery - Behavior
timeFrame: Follow-Up, 1 month after the intervention
measure: COVID-19 Impact Battery - Behavior
timeFrame: Follow-Up, 3 months after the intervention
measure: COVID-19 Impact Battery - Worry
timeFrame: Baseline, pre-intervention
measure: COVID-19 Impact Battery - Worry
timeFrame: Immediately after the intervention
measure: COVID-19 Impact Battery - Worry
timeFrame: Follow-Up, 1 month after the intervention
measure: COVID-19 Impact Battery - Worry
timeFrame: Follow-Up, 3 months after the intervention
measure: COVID-19 Impact Battery - Disability
timeFrame: Baseline, pre-intervention
measure: COVID-19 Impact Battery - Disability
timeFrame: Immediately after the intervention
measure: COVID-19 Impact Battery - Disability
timeFrame: Follow-Up, 1 month after the intervention
measure: COVID-19 Impact Battery - Disability
timeFrame: Follow-Up, 3 months after the intervention
measure: COVID-19 Items
timeFrame: Baseline, pre-intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
timeFrame: Baseline, pre-intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
timeFrame: During the Intervention (Weeks 1-5)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
timeFrame: Immediately after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
timeFrame: Follow-Up, 1 month after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale
timeFrame: Follow-Up, 3 months after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
timeFrame: Baseline, pre-intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
timeFrame: During the Intervention (Weeks 1-5)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
timeFrame: Immediately after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
timeFrame: Follow-Up, 1 month after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale
timeFrame: Follow-Up, 3 months after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
timeFrame: Baseline, pre-intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
timeFrame: During the Intervention (Weeks 1-5)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
timeFrame: Immediately after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
timeFrame: Follow-Up, 1 month after the intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale
timeFrame: Follow-Up, 3 months after the intervention
measure: Anxiety Sensitivity Index 3 (ASI-3)
timeFrame: Baseline, pre-intervention
measure: Anxiety Sensitivity Index 3 (ASI-3)
timeFrame: During the Intervention (Weeks 1-5)
measure: Anxiety Sensitivity Index 3 (ASI-3)
timeFrame: Immediately after the intervention
measure: Anxiety Sensitivity Index 3 (ASI-3)
timeFrame: Follow-Up, 1 month after the intervention
measure: Anxiety Sensitivity Index 3 (ASI-3)
timeFrame: Follow-Up, 3 months after the intervention
measure: Intolerance of Uncertainty-12
timeFrame: Baseline, pre-intervention
measure: Intolerance of Uncertainty-12
timeFrame: During the Intervention (Weeks 1-5)
measure: Intolerance of Uncertainty-12
timeFrame: Immediately after the intervention
measure: Intolerance of Uncertainty-12
timeFrame: Follow-Up, 1 month after the intervention
measure: Intolerance of Uncertainty-12
timeFrame: Follow-Up, 3 months after the intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, pre-intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Immediately after the intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Follow-Up, 1 month after the intervention
measure: Insomnia Severity Index (ISI)
timeFrame: Follow-Up, 3 months after the intervention
measure: Depressive Symptom Index - Suicidality Subscale (DSI-SS)
timeFrame: Baseline, pre-intervention
measure: Depressive Symptom Index - Suicidality Subscale (DSI-SS)
timeFrame: Immediately after the intervention
measure: Depressive Symptom Index - Suicidality Subscale (DSI-SS)
timeFrame: Follow-Up, 1 month after the intervention
measure: Depressive Symptom Index - Suicidality Subscale (DSI-SS)
timeFrame: Follow-Up, 3 months after the intervention
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline, pre-intervention
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Immediately after the intervention
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Follow-Up, 1 month after the intervention
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Follow-Up, 3 months after the intervention
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline, pre-intervention
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Immediately after the intervention
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Follow-Up, 1 month after the intervention
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Follow-Up, 3 months after the intervention
measure: Fear of Arousal Questionnaire (FAQ)
timeFrame: Baseline, pre-intervention
measure: Fear of Arousal Questionnaire (FAQ)
timeFrame: Immediately after the intervention
measure: Fear of Arousal Questionnaire (FAQ)
timeFrame: Follow-Up, 1 month after the intervention
measure: Fear of Arousal Questionnaire (FAQ)
timeFrame: Follow-Up, 3 months after the intervention
measure: National Institutes of Health (NIH) Toolbox Loneliness Scale
timeFrame: Baseline, pre-intervention
measure: National Institutes of Health (NIH) Toolbox Loneliness Scale
timeFrame: During the Intervention (Weeks 1-5)
measure: National Institutes of Health (NIH) Toolbox Loneliness Scale
timeFrame: Immediately after the intervention
measure: National Institutes of Health (NIH) Toolbox Loneliness Scale
timeFrame: Follow-Up, 1 month after the intervention
measure: National Institutes of Health (NIH) Toolbox Loneliness Scale
timeFrame: Follow-Up, 3 months after the intervention
measure: Exit Interview
timeFrame: Immediately after the intervention
measure: Ecological Momentary Assessment (EMA) questions
timeFrame: During the Intervention (Weeks 1-5)
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
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