NCT04365972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

7 days

First QC Date

April 24, 2020

Last Update Submit

May 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change from baseline of the total score of the Health Anxiety Inventory

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

  • Change from baseline of the total score of the State Anxiety Inventory

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

  • Change from Baseline of the total score of the PHQ-9

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

  • Change from Baseline of the total score of the GAD-7

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

Study Arms (1)

Home-delivered attention bias modification (ABM)

EXPERIMENTAL

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)

Interventions

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.

Home-delivered attention bias modification (ABM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • A diagnosis of dyslexia or other reading disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Yair Bar-Haim, PhD

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Yair Bar-Haim

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

April 23, 2020

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations