Anxiety DisordersNCT02272959
Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth Who do Not Respond to CBT
A study testing Attention bias modification treatment (ABMT) in people with Anxiety Disorders, run by Yair Bar-Haim at 1 site in Israel.
Trial summary
First-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. 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)
- 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
- Jan 2015to Jul 2019
- 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
- To be included all youth must:
- have received a full course of CBT and were deemed treatment non-responders.
- they must still have a primary diagnosis of GAD, SOP, or SAD.
- if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
- if they have tics or impulse control problems, those problems must be treated with medication and 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 psychosocial 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.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv University
Tel Aviv
Yair Bar-Haim, PhD, yair1@post.tau.ac.il
Marian Linetzky, marian.linetzky@gmail.com
About this study
Official title: Attention Bias Modification Treatment for Children With Anxiety Disorders Who do Not Respond to Cognitive Behavioral Therapy: A Randomized Controlled Trial
First-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. What are the treatment options for these youth? Unfortunately, there is not a single empirical study in the youth anxiety treatment literature that has systematically examined treatment augmentation for youth who fail to respond to CBT. Empirical efforts to address this issue are important because youth who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders. This study will address this gap via double-blind randomized controlled trial of Attention Bias Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard CBT. Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. Here, participants will be CBT non-responders who will be assessed by using clinical interviews and parent- and self-rated questionnaires before and after eight sessions of ABMT or placebo control, and again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We also expect the findings to inform pathways to treatments for anxious children who do not respond to current standard first-line therapy, and to provide initial information on mechanisms of ABMT efficacy.
- Conditions
- Anxiety Disorders
- Being tested
- Attention bias modification treatment (ABMT), Attention Control Condition
- Keywords
- Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology
- 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 using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.
Attention Control ConditionBehavioural
Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.
| 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 stimuli. Receives: Behavioral: Attention bias modification treatment (ABMT) |
| Placebo Group | Placebo comparator | Attention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli. Receives: Behavioral: Attention Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Anxiety Rating Scale (PARS)
The PARS assesses global anxiety severity across different anxiety disorders in youth.
Measured: expected average time frame of 6 weeks.
Secondary outcomes (1)
Anxiety Related Emotional Disorders - 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.
Screen for Child
Measured: expected average time frame of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yair Bar-Haim
- Sponsor type
- University, hospital or other
- Collaborators
- United States - Israel Binational Science Foundation, Schneider Children's Hospital, Sheba Medical Center
- Responsible party
- Sponsor-investigator, Yair Bar-Haim, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272959
- Sponsor's protocol ID
- loe140498ctil
- Status last verified
- Sep 2018
- First submitted
- 21 Oct 2014
- 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 for Children With Anxiety Disorders Who do Not Respond to Cognitive Behavioral Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02272959
- Acronym / sponsor ID
- loe140498ctil
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety/Anxiety disorders, Clinical trials, treatment, cognition, computer/Internet technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yair Bar-HaimUniversity, hospital or other
- Collaborators
- United States - Israel Binational Science Foundation, Schneider Children's Hospital, Sheba Medical Center
- Study start
- Jan 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 23 Oct 2014 (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.
First-line psychosocial treatments for anxiety disorders in children are largely exposure-based cognitive behavioral therapies (CBTs). Despite strong evidence supporting CBT's efficacy, for up to 50% of youth patients, symptoms of anxiety persist after a full course of treatment. What are the treatment options for these youth? Unfortunately, there is not a single empirical study in the youth anxiety treatment literature that has systematically examined treatment augmentation for youth who fail to respond to CBT. Empirical efforts to address this issue are important because youth who do not respond to CBT continue to suffer emotional distress and impairment associated with anxiety disorders. This study will address this gap via double-blind randomized controlled trial of Attention Bias Modification Treatment (ABMT) for anxious 10-18 year-olds who did not respond to standard CBT. Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. ABMT utilizes computer-based protocols to implicitly modify biased attentional patterns in anxious patients. Here, participants will be CBT non-responders who will be assessed by using clinical interviews and parent- and self-rated questionnaires before and after eight sessions of ABMT or placebo control, and again at an eight-week follow-up. We expect to see reduction in anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group. We also expect the findings to inform pathways to treatments for anxious children who do not respond to current standard first-line therapy, and to provide initial information on mechanisms of ABMT efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| 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 stimuli. |
| Placebo Group | Placebo comparator | Behavioral: Attention Control ConditionAttention training via repeated trials of a dot-probe task not intended to change threat-related attention patterns using only neutral stimuli. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- have received a full course of CBT and were deemed treatment non-responders.
- they must still have a primary diagnosis of GAD, SOP, or SAD.
- if they have comorbid attention deficit hyperactivity disorder (ADHD) or depressive disorders, it must be treated with medication and stable.
- if they have tics or impulse control problems, those problems must be treated with medication and 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 psychosocial 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 using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli. | Behavioural | Attention Bias Modification treatment (ABMT) |
| Attention Control ConditionAttention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli. | Behavioural | Placebo Group |
Primary outcome
The Pediatric Anxiety Rating Scale (PARS)
Time frame: expected average time frame of 6 weeks.
The PARS assesses global anxiety severity across different anxiety disorders in youth.
1 secondary outcome
Anxiety Related Emotional Disorders - Child/Parent Version (SCARED-C/P)
Time frame: expected average time frame of 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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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.
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) in people with Anxiety Disorders, run by Yair Bar-Haim 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 5 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yair Bar-Haim, Prof. (972-3-6405465, yair1@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Anxiety Rating Scale (PARS) (time frame: expected average time frame of 6 weeks.). 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.