Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365972
• Other study ID #: TAU-COVID-19
• Status: Completed
• Phase: N/A
• Start date: April 23, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Attention Bias Modification (ABM)
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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of the total score of a novel COVID-19 anxiety inventory	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	Change from baseline of the total score of the Health Anxiety Inventory	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
Secondary	Change from baseline of the total score of the State Anxiety Inventory	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
Secondary	Change from Baseline of the total score of the PHQ-9	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
Secondary	Change from Baseline of the total score of the GAD-7	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