Acceptability/Feasibility of COVID-19 Intervention of a Virtual Group Intervention for COVID-19 Distress
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Coping Crew (Behavioral)
结局指标
主要结局
Satisfaction with the intervention as assessed by Client Satisfaction Questionnaire-8
时间窗: Immediately after the intervention
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.
Feasibility of service as assessed by response rates for the Ecological Momentary Assessment/Ecological Momentary Intervention component of the intervention
时间窗: 5-week EMA/EMI, During the Intervention (Weeks 1-5)
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.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale(Follow-Up, 3 months after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale(Follow-Up, 3 months after the intervention)
- Anxiety Sensitivity Index 3 (ASI-3)(Follow-Up, 3 months after the intervention)
- COVID-19 Impact Battery - Behavior(Follow-Up, 3 months after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale(Follow-Up, 3 months after the intervention)
- Intolerance of Uncertainty-12(Follow-Up, 3 months after the intervention)
- COVID-19 Impact Battery - Worry(Follow-Up, 3 months after the intervention)
- COVID-19 Impact Battery - Disability(Follow-Up, 3 months after the intervention)
- COVID-19 Items(Baseline, pre-intervention)
- Insomnia Severity Index (ISI)(Follow-Up, 3 months after the intervention)
- Drug Use Disorders Identification Test (DUDIT)(Follow-Up, 3 months after the intervention)
- Depressive Symptom Index - Suicidality Subscale (DSI-SS)(Follow-Up, 3 months after the intervention)
- Alcohol Use Disorder Identification Test (AUDIT)(Follow-Up, 3 months after the intervention)
- Fear of Arousal Questionnaire (FAQ)(Follow-Up, 3 months after the intervention)
- National Institutes of Health (NIH) Toolbox Loneliness Scale(Follow-Up, 3 months after the intervention)
- Exit Interview(Immediately after the intervention)
- Ecological Momentary Assessment (EMA) questions(During the Intervention (Weeks 1-5))
- 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 - Worry(Baseline, pre-intervention)
- COVID-19 Impact Battery - Worry(Immediately after the intervention)
- COVID-19 Impact Battery - Worry(Follow-Up, 1 month after the intervention)
- COVID-19 Impact Battery - Disability(Baseline, pre-intervention)
- COVID-19 Impact Battery - Disability(Immediately after the intervention)
- COVID-19 Impact Battery - Disability(Follow-Up, 1 month after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale(Baseline, pre-intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale(During the Intervention (Weeks 1-5))
- Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale(Immediately after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scale(Follow-Up, 1 month after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale(Baseline, pre-intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale(During the Intervention (Weeks 1-5))
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale(Immediately after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale(Follow-Up, 1 month after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale(Baseline, pre-intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale(During the Intervention (Weeks 1-5))
- Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale(Immediately after the intervention)
- Patient-Reported Outcomes Measurement Information System (PROMIS) stress scale(Follow-Up, 1 month after the intervention)
- Anxiety Sensitivity Index 3 (ASI-3)(Baseline, pre-intervention)
- Depressive Symptom Index - Suicidality Subscale (DSI-SS)(Follow-Up, 1 month after the intervention)
- Anxiety Sensitivity Index 3 (ASI-3)(During the Intervention (Weeks 1-5))
- Anxiety Sensitivity Index 3 (ASI-3)(Immediately after the intervention)
- Anxiety Sensitivity Index 3 (ASI-3)(Follow-Up, 1 month after the intervention)
- Intolerance of Uncertainty-12(Baseline, pre-intervention)
- Intolerance of Uncertainty-12(During the Intervention (Weeks 1-5))
- Intolerance of Uncertainty-12(Immediately after the intervention)
- Intolerance of Uncertainty-12(Follow-Up, 1 month after the intervention)
- Insomnia Severity Index (ISI)(Baseline, pre-intervention)
- Insomnia Severity Index (ISI)(Immediately after the intervention)
- Insomnia Severity Index (ISI)(Follow-Up, 1 month after the intervention)
- Depressive Symptom Index - Suicidality Subscale (DSI-SS)(Baseline, pre-intervention)
- Depressive Symptom Index - Suicidality Subscale (DSI-SS)(Immediately after the intervention)
- Alcohol Use Disorder Identification Test (AUDIT)(Baseline, pre-intervention)
- Alcohol Use Disorder Identification Test (AUDIT)(Immediately after the intervention)
- Alcohol Use Disorder Identification Test (AUDIT)(Follow-Up, 1 month after the intervention)
- Drug Use Disorders Identification Test (DUDIT)(Baseline, pre-intervention)
- Drug Use Disorders Identification Test (DUDIT)(Immediately after the intervention)
- Drug Use Disorders Identification Test (DUDIT)(Follow-Up, 1 month after the intervention)
- Fear of Arousal Questionnaire (FAQ)(Baseline, pre-intervention)
- Fear of Arousal Questionnaire (FAQ)(Immediately after the intervention)
- Fear of Arousal Questionnaire (FAQ)(Follow-Up, 1 month after the intervention)
- National Institutes of Health (NIH) Toolbox Loneliness Scale(Baseline, pre-intervention)
- National Institutes of Health (NIH) Toolbox Loneliness Scale(During the Intervention (Weeks 1-5))
- National Institutes of Health (NIH) Toolbox Loneliness Scale(Immediately after the intervention)
- National Institutes of Health (NIH) Toolbox Loneliness Scale(Follow-Up, 1 month after the intervention)
研究者
Nicholas Allan
Assistant Professor of Clinical Psychology
Ohio University