Anxiety DisorderNCT01730625
Augmenting Effects of ABMT on CBT in Anxious Children: A Randomized Clinical Trial
A study testing Cognitive behavioral therapy for anxiety and Attention Bias Modification Treatment in people with Anxiety Disorder, run by Tel Aviv University.
Trial summary
The development of easily disseminated and efficacious treatment of psychiatric disorder is an important goal for translational neuroscience research. To that end, Attention Bias Modification Treatment (ABMT), a novel intervention targeting threat-related attention biases, has been shown to reduce anxiety in adults. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Cognitive behavioral therapy for anxiety and Attention Bias Modification Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Jul 2012
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children ranging in age from 6 - 18 year
- At least one clinical diagnoses of either separation anxiety disorder (SAD), social phobia (SP), specific phobia, or generalized anxiety disorder (GAD) (American Psychiatric Association [APA], 1994)
Who cannot join
- Lifetime history of psychosis
- Child's inability to comply to CBT
- Diagnosis of post traumatic stress disorder (PTSD), diagnosis of obsessive compulsive disorder (OCD), or selective mutism
About this study
Official title: Augmenting Effects of Attention Bias Modification Treatment on Cognitive Behavioral Therapy in Anxious Children: A Randomized Clinical Trial
The development of easily disseminated and efficacious treatment of psychiatric disorder is an important goal for translational neuroscience research. To that end, Attention Bias Modification Treatment (ABMT), a novel intervention targeting threat-related attention biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the treatment of choice for anxiety disorders. Studying this question in youth is particularly important given that the onset of most anxiety disorders is during childhood, and early interventions may reduce long-term affliction. The current study is the first randomized control trial designed to examine the augmenting effects of ABMT on CBT among clinically anxious youth.
The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic tool. During training, the target location is systematically manipulated to increase the proportion of targets appearing at the location opposite the patient's bias. For example, in a training protocol intended to reduce threat bias, targets would appear more frequently at locations of neutral than threat stimuli.
Read more
Although CBT is an effective treatment for anxiety disorders, combining it with other treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two interventions targeting different aspects of anxiety and therefore could potentially complement one another. While CBT modifies explicit and voluntary attention through verbal intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT, the integration of the two treatments can have few significant benefits: First, it will combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce the number of patients who respond poorly to CBT or do not respond at all. Second, computer-based training of attention may be more acceptable than traditional in-person therapy formats for some children and adolescents and can raise the cooperation in therapy. Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered consistently
The current study was designed to examine the ABMT augmentation effects on CBT for children with anxiety disorders. This study is the first randomized control trial in clinically anxious youth. Participants were randomly assigned to one of three conditions: 1. Training condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT alone). We hypothesize that participants in the training condition will show the greatest improvement in anxiety symptoms.
- Conditions
- Anxiety Disorder
- Being tested
- Cognitive behavioral therapy for anxiety, Attention Bias Modification Treatment
- Keywords
- Attention bias modification treatment (ABMT), Attention biases, Anxious children, Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for anxietyBehavioural
Attention Bias Modification TreatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ABMT + CBT | Experimental | CBT and ABMT Receives: Behavioral: Cognitive behavioral therapy for anxiety; Behavioral: Attention Bias Modification Treatment |
| CBT Alone | Other | CBT alone (compare/control group) Receives: Behavioral: Cognitive behavioral therapy for anxiety |
| ABMT placebo + CBT | Placebo comparator | ABMT placebo training and CBT Receives: Behavioral: Cognitive behavioral therapy for anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of anxiety symptoms (based on ADIS)
Diagnosis was established with a structured psychiatric interview, the ADIS for DSM-IV: C/P {Albano, 1996 #17}, which assesses the major anxiety, mood, and externalizing DSM-IV disorders experienced by children. The ADIS possesses excellent test-retest reliability for both symptom scales and diagnoses {Silverman, 2001 #1}, and has been translated to Hebrew and back translated in collaboration with the original authors. Interviewers were psychology graduate students who were trained on ADIS administration for couple of weeks. Two experienced clinical psychologist provided supervision for the interviewers on clinical issues that arise during these diagnostic assessments.
Measured: Change from baseline to up to 3 weeks after last treatment session
Change in severity of anxiety symptoms (based on ADIS)
ADIS interview (see above)
Measured: Change from baseline to up to 3 weeks after last treatment session
Secondary outcomes (1)
SCARED parent/child
The SCARED-R is 41- items parent and child reported questionnaire, measuring DSM-IV defined anxiety disorder symptoms in children. The scale measures symptoms of separation anxiety, generalized anxiety disorder, panic disorder, social phobia and school phobia. SCARED-R total and subscale scores can be obtained by summing across relevant items. The SCARED-R is a valid and reliable child anxiety instrument {Muris, 2001 #2;Muris, 2001 #3;Muris, 1999 #4} that has been extensively used in clinical and research contexts in Israel {Eldar, 2012 #32}.
Measured: pre and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 119 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, Ph.D, Principal investigator, Tel Aviv UniversityTomer Shechner, Ph.D, Study director, Tel Aviv University/Schneider children medical centerAlan Apter, M.D., Study chair, Tel Aviv University/Schnider children medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730625
- Sponsor's protocol ID
- ABMT-RCT
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.
PubMed 22423353Shechner T, Rimon-Chakir A, Britton JC, Lotan D, Apter A, Bliese PD, Pine DS, Bar-Haim Y. Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):61-71. doi: 10.1016/j.jaac.2013.09.016. Epub 2013 Oct 10.
PubMed 24342386
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Effects of Attention Bias Modification Treatment on Cognitive Behavioral Therapy in Anxious Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01730625
- Acronym / sponsor ID
- ABMT-RCT
- Conditions
- Anxiety Disorder
- Keywords
- Attention bias modification treatment (ABMT), Attention biases, Anxious children, Cognitive Behavioral Therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Nov 2012 (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.
The development of easily disseminated and efficacious treatment of psychiatric disorder is an important goal for translational neuroscience research. To that end, Attention Bias Modification Treatment (ABMT), a novel intervention targeting threat-related attention biases, has been shown to reduce anxiety in adults. To date, only one RCT study examined whether ABMT reduces clinical anxiety in children {Eldar, 2012 #32}, and no study has examined whether ABMT augments the efficacy of Cognitive Behavioral Treatment (CBT), the treatment of choice for anxiety disorders. Studying this question in youth is particularly important given that the onset of most anxiety disorders is during childhood, and early interventions may reduce long-term affliction. The current study is the first randomized control trial designed to examine the augmenting effects of ABMT on CBT among clinically anxious youth.
The purpose of Attention Bias Modification Therapy (ABMT) is to implicitly shape anxiety-related biases in attention orienting. ABMT uses the dot-probe task as a therapeutic tool. During training, the target location is systematically manipulated to increase the proportion of targets appearing at the location opposite the patient's bias. For example, in a training protocol intended to reduce threat bias, targets would appear more frequently at locations of neutral than threat stimuli.
Although CBT is an effective treatment for anxiety disorders, combining it with other treatment such as ABMT could result in additional treatment effects. CBT and ABMT are two interventions targeting different aspects of anxiety and therefore could potentially complement one another. While CBT modifies explicit and voluntary attention through verbal intervention, ABMT alters implicit and involuntary attentional biases. If ABMT augments CBT, the integration of the two treatments can have few significant benefits: First, it will combine the explicit learning of CBT with the implicit learning of ABMT and by that reduce the number of patients who respond poorly to CBT or do not respond at all. Second, computer-based training of attention may be more acceptable than traditional in-person therapy formats for some children and adolescents and can raise the cooperation in therapy. Finally, the CBT setting and the therapist presence can help to insure that ABMT is delivered consistently
The current study was designed to examine the ABMT augmentation effects on CBT for children with anxiety disorders. This study is the first randomized control trial in clinically anxious youth. Participants were randomly assigned to one of three conditions: 1. Training condition (CBT+ABMT), 2. Placebo condition (CBT+ ABMT-Placebo) 3. Control condition (CBT alone). We hypothesize that participants in the training condition will show the greatest improvement in anxiety symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABMT + CBT | Experimental | Behavioral: Cognitive behavioral therapy for anxiety, Behavioral: Attention Bias Modification TreatmentCBT and ABMT |
| CBT Alone | Other | Behavioral: Cognitive behavioral therapy for anxietyCBT alone (compare/control group) |
| ABMT placebo + CBT | Placebo comparator | Behavioral: Cognitive behavioral therapy for anxietyABMT placebo training and CBT |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children ranging in age from 6 - 18 year
- At least one clinical diagnoses of either separation anxiety disorder (SAD), social phobia (SP), specific phobia, or generalized anxiety disorder (GAD) (American Psychiatric Association [APA], 1994)
Key exclusion criteria (3 listed)
- Lifetime history of psychosis
- Child's inability to comply to CBT
- Diagnosis of post traumatic stress disorder (PTSD), diagnosis of obsessive compulsive disorder (OCD), or selective mutism
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 |
|---|---|---|
| Cognitive behavioral therapy for anxiety | Behavioural | ABMT + CBT, ABMT placebo + CBT, CBT Alone |
| Attention Bias Modification Treatment | Behavioural | ABMT + CBT |
Primary outcome
Change in frequency of anxiety symptoms (based on ADIS)
Time frame: Change from baseline to up to 3 weeks after last treatment session
Diagnosis was established with a structured psychiatric interview, the ADIS for DSM-IV: C/P {Albano, 1996 #17}, which assesses the major anxiety, mood, and externalizing DSM-IV disorders experienced by children. The ADIS possesses excellent test-retest reliability for both symptom scales and diagnoses {Silverman, 2001 #1}, and has been translated to Hebrew and back translated in collaboration with the original authors. Interviewers were psychology graduate students who were trained on ADIS administration for couple of weeks. Two experienced clinical psychologist provided supervision for the interviewers on clinical issues that arise during these diagnostic assessments.
Change in severity of anxiety symptoms (based on ADIS)
Time frame: Change from baseline to up to 3 weeks after last treatment session
ADIS interview (see above)
1 secondary outcome
SCARED parent/child
Time frame: pre and 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 21 Nov 2012.
- Background: PubMed 22423353Eldar S, Apter A, Lotan D, Edgar KP, Naim R, Fox NA, Pine DS, Bar-Haim Y. Attention bias modification treatment for pediatric anxiety disorders: a randomized controlled trial. Am J Psychiatry. 2012 Feb;169(2):213-20. doi: 10.1176/appi.ajp.2011.11060886.
- Derived from this study: PubMed 24342386Shechner T, Rimon-Chakir A, Britton JC, Lotan D, Apter A, Bliese PD, Pine DS, Bar-Haim Y. Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):61-71. doi: 10.1016/j.jaac.2013.09.016. Epub 2013 Oct 10.
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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, Ph.D principal investigator
Tel Aviv University
Tomer Shechner, Ph.D study director
Tel Aviv University/Schneider children medical center
Alan Apter, M.D. study chair
Tel Aviv University/Schnider children medical center
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for anxiety and Attention Bias Modification Treatment in people with Anxiety Disorder, run by Tel Aviv University.
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 2 inclusion and 3 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 in frequency of anxiety symptoms (based on ADIS) (time frame: Change from baseline to up to 3 weeks after last treatment session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730625, which also lists 2 linked publications.
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 21 Nov 2012.