Project H-COVID: Evaluating Hyper-Brief, Online Materials During the COVID-19 Pandemic

NCT04459455 | Completed

• 1 other identifier: IRB2020-00204
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety

Outcome Measures

Primary Outcomes (3)

• Change in Anxiety Control Questionnaire (ACQ) from Baseline to Immediately Post-Intervention

  ACQ is a 30-item questionnaire that measures an individual's level of agreement with a set of beliefs. Each item is scored on a scale from 0 (strongly disagree) to 5 (strongly agree) based on how much the statement is typical of the individual. The questionnaire measures domains of emotion control, threat control, and stress control, but only the emotion control scale (4 questions) will be used for the purposes of this study.

  Baseline, immediately post-intervention, 2-week follow-up

• Change in Generalized Anxiety Disorder-7 (GAD-7) from Baseline to 2-week follow-up

  The GAD-7 asks participants to rate 7 statements based on how generally anxious they have felt over the past 2 weeks. Participants rate the 7 statements on a 4 point scale ranging from 0 (Not at all) to 3 (Nearly every day). Total score ranges from 0 to 21 with higher scores representing higher generalized anxiety.

  Baseline, 2-week follow-up

• Change in Activity Social Distancing Intentions - 3 item version (SOC-D) from Baseline to immediately post-intervention

  As validated measures for social distancing intentions do not yet exist, the 3 questions used in this measure are derived from the standardized item bank provided by the Center for Disease Control. The three questions ask participants to rate how long they believe others would be willing to engage in social distancing behaviors regarding large events, public spaces, and private gatherings. Participants rate the 3 statements on a 4 point scale ranging from 1 (Less than a Month) to 4 (4 months or more). Total score ranges from 4 to 12, with a higher score indicating greater levels of intention to socially distance.

  Baseline, immediately post-intervention

Secondary Outcomes (7)

• COVID-19 Related Questions

  Baseline

• Inventory of Depression and Anxiety Symptoms (IDAS)

  Baseline

• Self Hate Scale (SHS)

  Baseline

• Comprehension Questions

  Immediately post-intervention

• Everyday Discrimination Scale-Short version

  Baseline

Study Arms (2)

Contain COVID Anxiety SSI

EXPERIMENTAL

Participants first receive normalizing scientific information (including neuroscience findings) that help explain why increased anxiety during the COVID-19 is a typical response. They then read testimonials from three other people from the US who have applied a 3-step action plan for coping more effectively with their anxiety. The entire intervention takes approximately 8 minutes and is completely entirely within the Qualtrics survey platform.

Behavioral: Contain COVID Anxiety SSI

Remain COVID Free SSI

PLACEBO COMPARATOR

This placebo SSI was developed to mirror the structure of the Contain COVID Anxiety SSI, discuss COVID-19 related content, and do so without as many of the potential active ingredients of effective SSIs. Participants will receive scientific information about how soap kills the COVID-19 virus, but no neuroscience information related to behaviors or behavior change.

Behavioral: Remain COVID Free SSI

Interventions

Contain COVID Anxiety SSI BEHAVIORAL

Participants first receive normalizing scientific information (including neuroscience findings) that help explain why increased anxiety during the COVID-19 is a typical response. They then read testimonials from three other people around the world who have applied a 3-step action plan for coping more effectively with their anxiety. The entire intervention takes approximately 8 minutes and is completely entirely within the Qualtrics survey platform.

Contain COVID Anxiety SSI

Remain COVID Free SSI BEHAVIORAL

This placebo SSI was developed to mirror the structure of the Contain COVID Anxiety SSI, discuss COVID-19 related content, and do so without as many of the potential active ingredients of effective SSIs. Participants will receive scientific information about how soap kills the COVID-19 virus, but no neuroscience information related to behaviors or behavior change.

Remain COVID Free SSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant's age is 18 years and older

You may not qualify if:

• Participant is younger than 18 years old

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794-2500, United States

Location

Related Publications (1)

• 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.

  PMID: 35230962 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This randomization of the order will occur using the randomizer within Qualtrics Survey Software, making the randomization process double-blind. To triple-blind our analysis process, the data will be downloaded from Qualtrics and the variable indicating what order the SSIs were presented in will be recoded before the primary analyses are conducted. Therefore, the primary analyses will be conducted without the knowledge of which condition is which.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: 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

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: August 19, 2020
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

US (1)