Clinical trial NCT04459455: Project H-COVID: Evaluating Hyper-Brief, Online Materials During the COVID-19 Pandemic
Official title: Project HF-COVID: Evaluating Hyper-Brief, Online Materials During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will use a between-subjects design; participants will be randomized to receive either the active Contain COVID Anxiety SSI or the placebo Remain COVID Free SSI
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test whether an online, self-administered SSI designed to strengthen perceived control over anxiety in the context of the COVID-19 pandemic (Contain COVID Anxiety) increases perceived control over anxiety more than a placebo, hand-washing-plan SSI (Remain COVID Free) in a weighted-probability sample of the United States (N = 500).

Detailed description: Elevations in state anxiety, when moderate and temporary, serve an adaptive function in pandemic contexts, facilitating health behaviors like self-protection and social distancing. However, for some people elevated state anxiety transitions to anxiety disorders, creating undue suffering and impairment. Nearly 33% of both Wuhan residents and Chinese citizens screened positive for generalized anxiety disorder during the COVID-19 pandemic, with uncontrollable, persistent COVID-19-related worries strongly predicting presence of GAD. Similarly, large surveys indicate that levels of anxiety symptoms are rising among United States citizens.

This finding aligns with a large body of literature indicating stronger perceived control over one's own anxiety buffers against a variety of anxiety disorders. Thus, in the context of COVID-19, there is a pressing need for materials that might strengthen perceived control over anxiety, thereby reducing risk for anxiety disorder onset. Ideally, such materials would (1) in no way undermine positive health behaviors, like social distancing, and (2) have capacity for broad-scale, immediate accessibility. Internet-based interventions may particularly valuable during the pandemic stage of COVID-19 due to the need for social distancing, and they have already scaled up to address needs in China. However, drop out from internet-based interventions can be up to 83% and intervention engagement is a frequent issue. Fortunately, single-session experiences (SSEs) can improve mental health related outcomes with similar effect sizes as multi-session therapies, and pilot data from our team suggests they can increase general perceived control (within-group dz = 0.70).

The goal of this project is to test a web-based platform where people can confidentially access and provide feedback on brief activities, called 'single-session experiences' (SSEs), which are about 8 minutes in length, entirely self-administered, and computer-based (Contain COVID Anxiety and Project Remain COVID Free). Previous activities following the same best practices as these experiences have been shown to be safe to complete; predicted significant reductions in psychological distress; and are entirely self-administered. We will recruit a weighted-probability sample of the United States through Prolific's online platform, N = 500. All data collected from the SSEs will be confidential, and the only identifiable information that will be recorded is the participants' Prolific ID to facilitate compensation, which will be deleted from the data after the compensation has been paid. Those that choose to complete the activities have the option to submit their advice to their peers and have it posted anonymously to the web-based platform. This will provide people with an option for an easily accessible activity designed to promote healthy coping skills and resilience in a welcoming environment through which they can learn with others and share experiences.

Eligibility criteria: Inclusion Criteria:

* Participant's age is 18 years and older

Exclusion Criteria:

* Participant is younger than 18 years old

Primary outcomes:
measure: Change in Anxiety Control Questionnaire (ACQ) from Baseline to Immediately Post-Intervention
timeFrame: Baseline, immediately post-intervention, 2-week follow-up
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) from Baseline to 2-week follow-up
timeFrame: Baseline, 2-week follow-up
measure: Change in Activity Social Distancing Intentions - 3 item version (SOC-D) from Baseline to immediately post-intervention
timeFrame: Baseline, immediately post-intervention
Secondary outcomes:
measure: COVID-19 Related Questions
timeFrame: Baseline
measure: Inventory of Depression and Anxiety Symptoms (IDAS)
timeFrame: Baseline
measure: Self Hate Scale (SHS)
timeFrame: Baseline
measure: Comprehension Questions
timeFrame: Immediately post-intervention
measure: Everyday Discrimination Scale-Short version
timeFrame: Baseline
measure: Perceived Changes in generalized anxiety symptoms
timeFrame: 2-week follow-up
measure: Activity Hand Washing Intentions - 3 item version (WASH-I)
timeFrame: Baseline, immediately post-intervention
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
References:
citation: Mullarkey M, Dobias M, Sung J, Ahuvia I, Shumake J, Beevers C, Schleider J. Web-Based Single Session Intervention for Perceived Control Over Anxiety During COVID-19: Randomized Controlled Trial. JMIR Ment Health. 2022 Apr 12;9(4):e33473. doi: 10.2196/33473.