AnxietyNCT04365972
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic
A study testing Attention Bias Modification (ABM) in people with Anxiety, run by Tel Aviv University at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Attention Bias Modification (ABM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Apr 2020to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A diagnosis of dyslexia or other reading disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial
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.
- Conditions
- Anxiety
- Being tested
- Attention Bias Modification (ABM)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Bias Modification (ABM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Attention Bias Modification (ABM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: up to 2 days pre-treatment and 1-2 days post-treatment
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.
Measured: up to 2 days pre-treatment and 1-2 days post-treatment
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.
Measured: up to 2 days pre-treatment and 1-2 days post-treatment
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.
Measured: up to 2 days pre-treatment and 1-2 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start23 Apr 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
- Investigators
- Yair Bar-Haim, PhD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365972
- Sponsor's protocol ID
- TAU-COVID-19
- Status last verified
- May 2020
- First submitted
- 24 Apr 2020
- Last updated
- 8 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial
- ClinicalTrials.gov ID
- NCT04365972
- Acronym / sponsor ID
- TAU-COVID-19
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-delivered attention bias modification (ABM) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- A diagnosis of dyslexia or other reading disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Home-delivered attention bias modification (ABM) |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Bar-Haim, PhD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Bias Modification (ABM) in people with Anxiety, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.