Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic

Sponsor

Tel Aviv University (Other)

Overall Status

Completed

CT.gov ID

NCT04365972

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Behavioral: Attention Bias Modification (ABM)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 23, 2020

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

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.	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.

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.

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.

Outcome Measures

Primary Outcome Measures

Change from baseline of the total score of a novel COVID-19 anxiety inventory [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 Outcome Measures

Change from baseline of the total score of the Health Anxiety Inventory [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
Change from baseline of the total score of the State Anxiety Inventory [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.
Change from Baseline of the total score of the PHQ-9 [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.
Change from Baseline of the total score of the GAD-7 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel Aviv University	Tel-Aviv		Israel	6997801

Sponsors and Collaborators

Tel Aviv University

Investigators

Principal Investigator: Yair Bar-Haim, PhD, Tel Aviv University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yair Bar-Haim, Prof. Yair Bar-Haim, Tel Aviv University

ClinicalTrials.gov Identifier:

NCT04365972

Other Study ID Numbers:

TAU-COVID-19

First Posted:

Apr 28, 2020

Last Update Posted:

May 8, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of May 8, 2020