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OpenTrials
Completed

NCT Number: NCT04365972

Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 6997801, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Attention Bias Modification (ABM)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Registry information

Official study title

Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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