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

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

      • Tel-Aviv, Israel, 6997801
        • Tel Aviv University

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.
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.

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
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.
up to 2 days pre-treatment and 1-2 days post-treatment

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
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
up to 2 days pre-treatment and 1-2 days post-treatment
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
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.
up to 2 days pre-treatment and 1-2 days post-treatment
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
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.
up to 2 days pre-treatment and 1-2 days post-treatment
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
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.
up to 2 days pre-treatment and 1-2 days post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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