- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04365972
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic
May 6, 2020 updated by: Yair Bar-Haim, Tel Aviv University
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial
The outbreak of the 2019 Coronavirus (COVID-19) pandemic is a major stressor leading to increased levels of anxiety, and specifically, an excessive fear of being infected and affected by the disease among major parts of the population.
At the same time, the access to mental health services is limited due to the lockdown policy applied in many countries worldwide, warranting the development of home-delivered interventions aimed at reducing stress and anxiety symptoms.
Attention Bias modification (ABM) has been found to be an efficacious computerized intervention to reduce anxiety symptoms.
In this open pilot trial, participants reporting on elevated levels of health anxiety concerning the COVID-19 epidemic will receive one session of ABM over 5 consecutive days (5 sessions total).
Symptoms of health anxiety, state anxiety, generalized anxiety, and depression will be measured at baseline and post-treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tel-Aviv, Israel, 6997801
- Tel Aviv University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 3 or more symptoms (out of 7) reported in the COVID-19 anxiety inventory with a score of 4 or 5.
- Fluent Hebrew
- Having a PC computer at home with internet access
Exclusion Criteria:
- A diagnosis of dyslexia or other reading disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home-delivered attention bias modification (ABM)
A home-delivered ABM comprised of 5 sessions using a variant of the dot-probe task in which the target probe always replaces neutral rather than threat (health-related) stimuli to induce diversion of attention away from threat.
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A home-delivered version of ABM will be administered in this open trial.
ABM will be comprised of 5 sessions with a variation of the dot-probe task in which the target probe always replaces the neutral stimuli to induce diversion of attention away from threat.
This condition was found effective in reducing anxiety symptoms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of the total score of a novel COVID-19 anxiety inventory
Time Frame: up to 2 days pre-treatment and 1-2 days post-treatment
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The COVID-19 anxiety inventory is a self-report questionnaire screening for concerns and fears regarding COVID-19 contagion.
The Inventory consists of 6 items.
Scores can range from 6 to 30, with higher scores denoting higher symptom severity.
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up to 2 days pre-treatment and 1-2 days post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of the total score of the Health Anxiety Inventory
Time Frame: up to 2 days pre-treatment and 1-2 days post-treatment
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The Health Anxiety Inventory (HAI) is a validated self-report measure assessing health anxiety.
Total score can range from 0 to 42, with higher scores denoting higher symptom severity
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up to 2 days pre-treatment and 1-2 days post-treatment
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Change from baseline of the total score of the State Anxiety Inventory
Time Frame: up to 2 days pre-treatment and 1-2 days post-treatment
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The State Anxiety Inventory is a validated self-report measure for state anxiety.
Total score can range from 20 to 80, with higher scores denoting higher levels of state anxiety.
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up to 2 days pre-treatment and 1-2 days post-treatment
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Change from Baseline of the total score of the PHQ-9
Time Frame: up to 2 days pre-treatment and 1-2 days post-treatment
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The PHQ-9 is a 9-item self-report scale for depression symptoms.
Scores can range from 0 to 27, with higher scores reflecting more symptoms of depression.
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up to 2 days pre-treatment and 1-2 days post-treatment
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Change from Baseline of the total score of the GAD-7
Time Frame: up to 2 days pre-treatment and 1-2 days post-treatment
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The GAD-7 is a 7-item self-report scale for generalized anxiety symptoms.
Scores can range from 0 to 21, with higher scores reflecting more symptoms of generalized anxiety.
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up to 2 days pre-treatment and 1-2 days post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2020
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
April 24, 2020
First Submitted That Met QC Criteria
April 27, 2020
First Posted (Actual)
April 28, 2020
Study Record Updates
Last Update Posted (Actual)
May 8, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAU-COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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