Anxiety DisordersNCT02460536
Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth
A study testing Attention Bias Modification treatment (ABMT), Exposure only +ABMT and Attention training only +ABMT in people with Anxiety Disorders, run by Tel Aviv University at 1 site in Israel.
Trial summary
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Attention Bias Modification treatment (ABMT), Exposure only +ABMT and Attention training only +ABMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to May 2018
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of GAD, SOP, or SAD.
- Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
- Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.
Who cannot join
- meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
- show high likelihood of hurting themselves or others.
- have not been living with a primary caregiver who is legally able to give consent for the child's participation.
- be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
- be involved currently in another psycho-social treatment.
- have a serious vision problem that is not corrected with prescription lenses.
- have a physical disability that interferes with their ability to click a mouse button rapidly and repeatedly.
Trial locations and contacts
1 site in 1 country.
About this study
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious 10-18 year-olds. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with youth and their parents. Attentional threat bias, Attentional control and interpretation of ambiguous information will also be measured to explore potential mediators of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to treatments for anxious children and to provide initial information on mechanisms of ABMT efficacy.
- Conditions
- Anxiety Disorders
- Being tested
- Attention Bias Modification treatment (ABMT), Exposure only +ABMT, Attention training only +ABMT, Placebo group
- Keywords
- attention bias modification treatment, attention training, anxiety disorders, clinical trials
- 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 treatment (ABMT)Behavioural
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli.
Exposure only +ABMTBehavioural
Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.
Attention training only +ABMTBehavioural
Attention training via repeated trials of a dot-probe task using non-emotional stimuli.
Placebo groupBehavioural
Identical discrimination task including a single non-emotional stimulus in each trial.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification treatment (ABMT) | Experimental | Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli. Receives: Behavioral: Attention Bias Modification treatment (ABMT) |
| Exposure only +ABMT | Active comparator | Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial. Receives: Behavioral: Exposure only +ABMT |
| Attention training only +ABMT | Active comparator | Attention training via repeated trials of a dot-probe task using non-emotional stimuli. Receives: Behavioral: Attention training only +ABMT |
| Placebo group | Placebo comparator | Identical discrimination task including a single non-emotional stimulus in each trial. Receives: Behavioral: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
The PARS assesses global anxiety severity across different anxiety disorders in youth.
Measured: 4 weeks, 8 weeks, and 18 weeks (follow-up)
Secondary outcomes (1)
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent Version (SCARED-C/P)
The SCARED is a 41-item self and parent-report instrument designed to assess anxiety in children and adolescents.
Measured: 4 weeks, 8 weeks, and 18 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460536
- Sponsor's protocol ID
- 2009341
- Status last verified
- Sep 2018
- First submitted
- 27 May 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth
- ClinicalTrials.gov ID
- NCT02460536
- Acronym / sponsor ID
- 2009341
- Conditions
- Anxiety Disorders
- Keywords
- attention bias modification treatment, attention training, anxiety disorders, clinical trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious 10-18 year-olds. Participants will be assessed using clinical interviews and parent- and self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and depression as measured by gold standard questionnaires as well as structured clinical interviews with youth and their parents. Attentional threat bias, Attentional control and interpretation of ambiguous information will also be measured to explore potential mediators of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to treatments for anxious children and to provide initial information on mechanisms of ABMT efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Attention Bias Modification treatment (ABMT) | Experimental | Behavioral: Attention Bias Modification treatment (ABMT)Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli. |
| Exposure only +ABMT | Active comparator | Behavioral: Exposure only +ABMTIdentical discrimination task including exposure to a single threat or neutral face stimulus in each trial. |
| Attention training only +ABMT | Active comparator | Behavioral: Attention training only +ABMTAttention training via repeated trials of a dot-probe task using non-emotional stimuli. |
| Placebo group | Placebo comparator | Behavioral: Placebo groupIdentical discrimination task including a single non-emotional stimulus in each trial. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Primary diagnosis of GAD, SOP, or SAD.
- Co-morbid attention deficit hyperactivity disorder (ADHD) or depressive disorders must be treated with medication and stable.
- Tics or impulse control problems must be treated with medication, stable and cause minimal or no impairment.
Key exclusion criteria (7 listed)
- meet diagnostic criteria for Organic Mental Disorders, Psychotic Disorders, Pervasive Developmental Disorders, or Mental Retardation.
- show high likelihood of hurting themselves or others.
- have not been living with a primary caregiver who is legally able to give consent for the child's participation.
- be a victim of previously undisclosed abuse requiring investigation or ongoing supervision.
- be involved currently in another psycho-social treatment.
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 treatment (ABMT)Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli. | Behavioural | Attention Bias Modification treatment (ABMT) |
| Exposure only +ABMTIdentical discrimination task including exposure to a single threat or neutral face stimulus in each trial. | Behavioural | Exposure only +ABMT |
| Attention training only +ABMTAttention training via repeated trials of a dot-probe task using non-emotional stimuli. | Behavioural | Attention training only +ABMT |
| Placebo groupIdentical discrimination task including a single non-emotional stimulus in each trial. | Behavioural | Placebo group |
Primary outcome
Change from baseline in anxiety symptoms - the Pediatric Anxiety Rating (PARS)
Time frame: 4 weeks, 8 weeks, and 18 weeks (follow-up)
The PARS assesses global anxiety severity across different anxiety disorders in youth.
1 secondary outcome
Change from baseline in anxiety related emotional disorders symptoms - Child/Parent Version (SCARED-C/P)
Time frame: 4 weeks, 8 weeks, and 18 weeks (follow-up)
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 18 Sep 2018.
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
The record lists no contact. Use the official record to reach the sponsor.
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 treatment (ABMT), Exposure only +ABMT and Attention training only +ABMT in people with Anxiety Disorders, 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 7 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 18 Sep 2018. 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. Some participants in this study may receive a placebo. 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 in anxiety symptoms - the Pediatric Anxiety Rating (PARS) (time frame: 4 weeks, 8 weeks, and 18 weeks (follow-up)). 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 18 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.