Anxiety DisorderATTENTIONCT03764644
Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders
A study testing Combined ABMT and CBT in people with Anxiety Disorder and Anxiety Disorder of Childhood, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive Behavioural Therapy; CBT) are around 50%. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Anxiety Disorder, Anxiety Disorder of Childhood, Separation Anxiety Disorder of Childhood, Early Onset
- What is being tested?
- Combined ABMT and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Jul 2017
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Eligible for participation are children (aged 8 to 16 years)
- Primary diagnosis of separation anxiety disorder,
- Primary diagnosis of generalized anxiety disorder
- Primary diagnosis of specific phobia
- Primary diagnosis of social phobia
Who cannot join
- IQ below 85
- poor command of the Dutch language
- serious physical disease
- psychosis
- substance abuse
- pervasive developmental disorder
Show all 13Show fewer
- obsessive-compulsive disorder
- posttraumatic stress disorder
- acute stress disorder
- panic disorder
- major depression
- anxiety medication during treatment
- any concurrent psychotherapy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus MC - Sophia Children's Hospital
Rotterdam, South Holland, 3000 CB
About this study
Official title: Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders: a Randomized, Double-blind, Controlled Trial
Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive Behavioural Therapy; CBT) are around 50%. Non-response increases the risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. These negative consequences endorse the urgent need to develop more effective and accessible treatments that enhance effectiveness of current treatment options. A promising new treatment for childhood anxiety disorders is Attention Bias Modification Treatment (ABMT). ABMT is based on evidence that anxiety-disordered individuals selectively allocate their attention toward threatening information (i.e. attention bias). This bias in early and automatic attention processes starts a cascade of subsequent biases in information processing and memory, resulting in heightened anxiety. Attention bias is an underlying mechanism of anxiety. Thus ABMT, which implicitly trains individuals to attend away from threatening information should alleviate anxiety. In contrast to ABMT, CBT explicitly targets later stages of information processing that are under volitional control. Meta-analyses of studies in adults have shown that ABMT indeed results in increased recovery rates and clinically significant changes in anxiety, compared to so-called "sham" attention training (control condition). Imaging studies have shown that ABMT modifies lateral prefrontal cortex activity to emotional stimuli. Despite its promising results, fewer studies have examined ABMT in anxiety-disordered children. The aim of this trial is to enhance treatment effectiveness by combining web-based ABMT with CBT in a large sample of anxiety-disordered children. The primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham attention training on anxiety disorder recovery rates and changes in anxiety. We hypothesize that (1) ABMT-augmented CBT will result in a significantly better treatment success than CBT alone, and (2) ABMT will result in a significantly better treatment success than sham attention training. The design will be a randomized, double-blind, sham-controlled clinical trial.
Read the detailed description
Anxiety disorders are the most prevalent psychiatric disorders, occurring in among 15% to 20% of children. Cognitive behavioral therapy (CBT) is currently the first-choice treatment for anxiety-disordered children. Despite proven efficacy, almost half of them do not respond, causing prolonged suffering. Children with persistent anxiety have an increased risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. Another concern is that only a small proportion of anxiety-disordered children actually receive treatment. These negative consequences in combination with the limited accessibility of treatment endorse the urgent need to develop more effective and accessible treatments that can enhance effectiveness of current treatment options.
A newly emerging and promising childhood anxiety treatment is Attention Bias Modification Treatment (ABMT). ABMT is build upon evidence that anxious children tend to selectively focus their attention on threatening information in the context of other non-threatening information, and that attention bias is related to development and maintenance of anxiety disorders. Children with an attention bias scan their environment for potential threat or danger thereby starting a cascade of subsequent processing biases in interpretation and memory, resulting in heightened anxiety.
Hence, as attention bias is an underlying mechanism of anxiety, treatment that diminishes attention bias toward threat in anxiety-disordered individuals should alleviate anxiety. Subsequently, several researchers began to examine the effect of ABMT, which implicitly trains anxiety-disordered individuals to attend away from threat toward neutral information. This is a different approach than CBT, which does not target early and automatic information processes, but addresses later stages of information processing that are under volitional control. Several studies highlighted the potential of ABMT in reducing anxiety levels in adults. A meta-analysis revealed that ABMT in adults produces significantly greater reductions in anxiety than sham control training, with a large effect size in clinical populations. A previous study found that 72% of the adults were free from their primary anxiety disorder after ABMT as compared to 11% after sham attention training, which is far more than CBT. These training effects were maintained at 4-month follow-up. Importantly, ABMT also modifies neural systems that are involved in the control of attention to emotional stimuli, in particular the lateral prefrontal cortex.
Despite the promising results in adults, ABMT has been scarcely examined in children. A few studies demonstrated a significant anxiolytic effect of ABMT, but not of the sham control condition. A major limitation of previous studies is that sample sizes were quite low and that a limited number of training sessions were provided. It has been shown that more training sessions enhance the magnitude of treatment effect. This is the first study that examines the effectiveness of a 9-session web-based ABMT in a large sample of anxiety-disordered children as well as examines the additive effect of web-based ABMT on CBT.
As reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood anxiety disorders is ABMT. A randomized, sham-controlled, double-blind trial of web-based Attention Bias Modification Treatment for childhood anxiety disorders will be conducted. One hundred twenty-eight children will be randomly allocated to a 9 session internet-delivered ABMT or sham attention training. The primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham attention training on anxiety disorder recovery rates and changes in anxiety.
- Conditions
- Anxiety Disorder, Anxiety Disorder of Childhood, Separation Anxiety Disorder of Childhood, Early Onset, Specific Phobia, Social Anxiety Disorder, Generalized Anxiety Disorder
- Being tested
- Combined ABMT and CBT, Combined Sham ABMT and CBT
- Medical subject headings
- Anxiety Disorders, Phobia, Specific, Phobia, Social, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ABMT and CBTBehavioural
ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Each session, participants see 160 trials of which 128 trials include one neutral and one threatening stimulus. The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
Combined Sham ABMT and CBTBehavioural
ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Of the 160 trials, the probe appears with equal frequency on the location of the neutral and threatening stimulus (128 trials). The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
| Study group | Role | What they receive |
|---|---|---|
| Combined ABMT and CBT | Experimental | 9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program Receives: Behavioral: Combined ABMT and CBT |
| Combined Sham ABMT and CBT | Sham comparator | 9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program Receives: Behavioral: Combined Sham ABMT and CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety disorder status
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Measured: After 3 weeks of ABMT or sham-ABMT
Anxiety disorder status
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Measured: After 10 weeks of CBT
Anxiety disorder status
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Measured: 6 months follow-up (from last CBT session)
Secondary outcomes (9)
Number of anxiety disorders
Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Measured: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Anxiety symptoms
Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms
Measured: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Depression symptoms
Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms
Measured: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Number of anxiety disorders
Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Measured: After 10 weeks of CBT
Anxiety symptoms
Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms
Measured: After 10 weeks of CBT
Depression symptoms
Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms
Measured: After 10 weeks of CBT
Number of anxiety disorders
Number of anxiety disorders according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Measured: 6 months follow-up (from last CBT session)
Anxiety symptoms
Total scale anxiety symptoms according to the Screen for Child Anxiety Related Emotional Disorders (SCARED-R), 69 items, range 0-138, higher score represents more symptoms
Measured: 6 months follow-up (from last CBT session)
Depression symptoms
Total scale depression symptoms according to the Child Depression Inventory (CDI), 27 items, range 0-54, higher score represents more symptoms
Measured: 6 months follow-up (from last CBT session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study startOct 2013
- Primary completionFeb 2017
- Study completionJul 2017
Why it stopped: Interim results showed high futility to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Double blind, sham-controlled, randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen Legerstee, Erasmus Medical Center
- Investigators
- Jeroen Legerstee, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764644
- Sponsor's protocol ID
- S13-11
- Acronym
- ATTENTIO
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders: a Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03764644
- Acronym / sponsor ID
- ATTENTIO / S13-11
- Conditions
- Anxiety Disorder, Anxiety Disorder of Childhood, Separation Anxiety Disorder of Childhood, Early Onset, Specific Phobia, Social Anxiety Disorder, Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim results showed high futility to continue
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 Dec 2018 (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.
Anxiety disorders are the most common childhood psychiatric disorders, with prevalence rates as high as 15% to 20%. Success rates of the first choice treatment strategy (i.e. Cognitive Behavioural Therapy; CBT) are around 50%. Non-response increases the risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. These negative consequences endorse the urgent need to develop more effective and accessible treatments that enhance effectiveness of current treatment options. A promising new treatment for childhood anxiety disorders is Attention Bias Modification Treatment (ABMT). ABMT is based on evidence that anxiety-disordered individuals selectively allocate their attention toward threatening information (i.e. attention bias). This bias in early and automatic attention processes starts a cascade of subsequent biases in information processing and memory, resulting in heightened anxiety. Attention bias is an underlying mechanism of anxiety. Thus ABMT, which implicitly trains individuals to attend away from threatening information should alleviate anxiety. In contrast to ABMT, CBT explicitly targets later stages of information processing that are under volitional control. Meta-analyses of studies in adults have shown that ABMT indeed results in increased recovery rates and clinically significant changes in anxiety, compared to so-called "sham" attention training (control condition). Imaging studies have shown that ABMT modifies lateral prefrontal cortex activity to emotional stimuli. Despite its promising results, fewer studies have examined ABMT in anxiety-disordered children. The aim of this trial is to enhance treatment effectiveness by combining web-based ABMT with CBT in a large sample of anxiety-disordered children. The primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham attention training on anxiety disorder recovery rates and changes in anxiety. We hypothesize that (1) ABMT-augmented CBT will result in a significantly better treatment success than CBT alone, and (2) ABMT will result in a significantly better treatment success than sham attention training. The design will be a randomized, double-blind, sham-controlled clinical trial.
Detailed description
Anxiety disorders are the most prevalent psychiatric disorders, occurring in among 15% to 20% of children. Cognitive behavioral therapy (CBT) is currently the first-choice treatment for anxiety-disordered children. Despite proven efficacy, almost half of them do not respond, causing prolonged suffering. Children with persistent anxiety have an increased risk for other psychiatric disorders, school dropout, social isolation, alcoholism, and suicide attempts. Another concern is that only a small proportion of anxiety-disordered children actually receive treatment. These negative consequences in combination with the limited accessibility of treatment endorse the urgent need to develop more effective and accessible treatments that can enhance effectiveness of current treatment options.
A newly emerging and promising childhood anxiety treatment is Attention Bias Modification Treatment (ABMT). ABMT is build upon evidence that anxious children tend to selectively focus their attention on threatening information in the context of other non-threatening information, and that attention bias is related to development and maintenance of anxiety disorders. Children with an attention bias scan their environment for potential threat or danger thereby starting a cascade of subsequent processing biases in interpretation and memory, resulting in heightened anxiety.
Hence, as attention bias is an underlying mechanism of anxiety, treatment that diminishes attention bias toward threat in anxiety-disordered individuals should alleviate anxiety. Subsequently, several researchers began to examine the effect of ABMT, which implicitly trains anxiety-disordered individuals to attend away from threat toward neutral information. This is a different approach than CBT, which does not target early and automatic information processes, but addresses later stages of information processing that are under volitional control. Several studies highlighted the potential of ABMT in reducing anxiety levels in adults. A meta-analysis revealed that ABMT in adults produces significantly greater reductions in anxiety than sham control training, with a large effect size in clinical populations. A previous study found that 72% of the adults were free from their primary anxiety disorder after ABMT as compared to 11% after sham attention training, which is far more than CBT. These training effects were maintained at 4-month follow-up. Importantly, ABMT also modifies neural systems that are involved in the control of attention to emotional stimuli, in particular the lateral prefrontal cortex.
Despite the promising results in adults, ABMT has been scarcely examined in children. A few studies demonstrated a significant anxiolytic effect of ABMT, but not of the sham control condition. A major limitation of previous studies is that sample sizes were quite low and that a limited number of training sessions were provided. It has been shown that more training sessions enhance the magnitude of treatment effect. This is the first study that examines the effectiveness of a 9-session web-based ABMT in a large sample of anxiety-disordered children as well as examines the additive effect of web-based ABMT on CBT.
As reviewed above, childhood anxiety disorders are highly prevalent and debilitating, and there is an urgent need for improvement of current treatment strategies. An innovative, but scarcely examined, treatment option for childhood anxiety disorders is ABMT. A randomized, sham-controlled, double-blind trial of web-based Attention Bias Modification Treatment for childhood anxiety disorders will be conducted. One hundred twenty-eight children will be randomly allocated to a 9 session internet-delivered ABMT or sham attention training. The primary aim is to compare ABMT-augmented CBT with CBT as monotherapy on recovery rates for anxiety disorders and changes in anxiety. The secondary aim is to compare ABMT with sham attention training on anxiety disorder recovery rates and changes in anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, sham-controlled, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Combined ABMT and CBT | Experimental | Behavioral: Combined ABMT and CBT9 sessions of Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program |
| Combined Sham ABMT and CBT | Sham comparator | Behavioral: Combined Sham ABMT and CBT9 sessions of Sham Attention Bias Modification Treatment (dot-probe based of 160 trials) followed by individual Cognitive Behavioral Therapy via FRIENDS program |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Eligible for participation are children (aged 8 to 16 years)
- Primary diagnosis of separation anxiety disorder,
- Primary diagnosis of generalized anxiety disorder
- Primary diagnosis of specific phobia
- Primary diagnosis of social phobia
Key exclusion criteria (13 listed)
- IQ below 85
- poor command of the Dutch language
- serious physical disease
- psychosis
- substance abuse
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 |
|---|---|---|
| Combined ABMT and CBTABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Each session, participants see 160 trials of which 128 trials include one neutral and one threatening stimulus. The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual | Behavioural | Combined ABMT and CBT |
| Combined Sham ABMT and CBTABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Of the 160 trials, the probe appears with equal frequency on the location of the neutral and threatening stimulus (128 trials). The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual | Behavioural | Combined Sham ABMT and CBT |
Primary outcome
Anxiety disorder status
Time frame: After 3 weeks of ABMT or sham-ABMT
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Anxiety disorder status
Time frame: After 10 weeks of CBT
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
Anxiety disorder status
Time frame: 6 months follow-up (from last CBT session)
Free of any anxiety disorder according to the Anxiety Disorders Interview Schedule for Children (ADIS-C)
9 secondary outcomes
Number of anxiety disorders
Time frame: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Anxiety symptoms
Time frame: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Depression symptoms
Time frame: After 3 weeks of ABMT or sham-ABMT, after 10 weeks of CBT, 6 months follow-up
Number of anxiety disorders
Time frame: After 10 weeks of CBT
Anxiety symptoms
Time frame: After 10 weeks of CBT
Depression symptoms
Time frame: After 10 weeks of CBT
Number of anxiety disorders
Time frame: 6 months follow-up (from last CBT session)
Anxiety symptoms
Time frame: 6 months follow-up (from last CBT session)
Depression symptoms
Time frame: 6 months follow-up (from last CBT session)
Results and safety
The study was stopped early (reason given: Interim results showed high futility to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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.
Jeroen Legerstee, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined ABMT and CBT in people with Anxiety Disorder and Anxiety Disorder of Childhood, run by Erasmus Medical Center at 1 site in Netherlands.
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 13 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: stopped early, as of the sponsor's last update on 5 Dec 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 Netherlands. 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 was stopped early (reason given: Interim results showed high futility to continue). Results are not available in the source record.
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?
Anxiety disorder status (time frame: After 3 weeks of ABMT or sham-ABMT). The study lists 3 primary outcomes in all. 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 5 Dec 2018.