Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention Bias Modification (ABM)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- Tel Aviv University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home-delivered attention bias modification (ABM)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04365972
Brief Title
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic
Official Title
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-delivered attention bias modification (ABM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification (ABM)
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline of the total score of a novel COVID-19 anxiety inventory
Description
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.
Time Frame
up to 2 days pre-treatment and 1-2 days post-treatment
Secondary Outcome Measure Information:
Title
Change from baseline of the total score of the Health Anxiety Inventory
Description
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
Time Frame
up to 2 days pre-treatment and 1-2 days post-treatment
Title
Change from baseline of the total score of the State Anxiety Inventory
Description
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.
Time Frame
up to 2 days pre-treatment and 1-2 days post-treatment
Title
Change from Baseline of the total score of the PHQ-9
Description
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.
Time Frame
up to 2 days pre-treatment and 1-2 days post-treatment
Title
Change from Baseline of the total score of the GAD-7
Description
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.
Time Frame
up to 2 days pre-treatment and 1-2 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv University
City
Tel-Aviv
ZIP/Postal Code
6997801
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic
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