Generalized Anxiety DisorderNCT01687764
Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children
A study testing Attentional Bias Modification Treatment (ABMT) - Active and Cognitive Behavioral Group Therapy in people with Generalized Anxiety Disorder and Separation Anxiety Disorder, run by Hospital de Clinicas de Porto Alegre at 4 sites in 4 countries.
Trial summary
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Anxiety Disorder
- What is being tested?
- Attentional Bias Modification Treatment (ABMT) - Active and Cognitive Behavioral Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2011to Jan 2013
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview
Who cannot join
- Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or SoAD in the clinical evaluation
- Current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood
- IQ < 70 (Raven)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
- Active, not recruiting
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
Australia1 site
- Active, not recruiting
University of Queensland
Brisbane Saint Lucia, Queensland, 4072
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-003
Giovanni A Salum Junior, MD, +55 51 33598983, gsalumjr@gmail.com
Rafaela Behs, MSc, +55 51 33598983, rafaelabehs@hotmail.com
About this study
Official title: Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children: a Randomized Clinical Trial
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children.
- Being tested
- Attentional Bias Modification Treatment (ABMT) - Active, Attentional Bias Modification Treatment - Placebo, Cognitive Behavioral Group Therapy, Psychoeducational Control Intervention
- Keywords
- Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD), Social Anxiety Disorder (SoAD)
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety, Separation, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional Bias Modification Treatment (ABMT) - ActiveOther
The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.
Attentional Bias Modification Treatment - PlaceboOther
The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.
Cognitive Behavioral Group TherapyBehavioural
"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
Psychoeducational Control InterventionBehavioural
Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
| Study group | Role | What they receive |
|---|---|---|
| CBGT+ABMT(active) | Experimental | Not described Receives: Other: Attentional Bias Modification Treatment (ABMT) - Active; Behavioral: Cognitive Behavioral Group Therapy |
| CBGT+ABMT(placebo) | Experimental | Not described Receives: Other: Attentional Bias Modification Treatment - Placebo; Behavioral: Cognitive Behavioral Group Therapy |
| PCI+ABMT(active) | Experimental | Not described Receives: Other: Attentional Bias Modification Treatment (ABMT) - Active; Behavioral: Psychoeducational Control Intervention |
| PCI+ABMT(placebo) | Placebo comparator | Not described Receives: Other: Attentional Bias Modification Treatment - Placebo; Behavioral: Psychoeducational Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anxiety Rating Scale (PARS) / continuous
Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up
Measured: Endpoint (week 10) and 6-month follow-up
Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up
Measured: Endpoint (week-10) and 6-month follow-up
Secondary outcomes (6)
Screen for Children and Anxiety Related Emotional Disorders (SCARED)
Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up
Measured: Endpoint (week-10) and 6-months follow-up
Childhood Depression Inventory (CDI)
Score change in CDI from baseline to week-10 and to 6-month follow-up
Measured: Endpoint (week-10) and 6-month follow-up
Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)
Score change in SNAP-IV from baseline to week-10 and 6-month follow-up
Measured: Endpoint (week-10) and 6-month follow-up
Spence Children's Anxiety Scale (SCAS)
Score change in SCAS from baseline to week-10 and to 6-month follow-up
Measured: Endpoint (week-10) and 6-month follow-up
Neuropsychological measures
Change in neuropsychological measures from baseline to week-10 and 6-month follow-up
Measured: Endpoint (week-10) and 6-month follow-up
Biological measures
Change in biological measures from baseline to week-10 and to 6-month follow-up
Measured: Endpoint (week-10) and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startAug 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisele G Manfro, MD, PhD, Principal investigator, Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto AlegreSilvia H Koller, PhD, Principal investigator, Federal University of Rio Grande do Sul / University of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687764
- Sponsor's protocol ID
- HCPA11-0249
- Status last verified
- Sep 2012
- First submitted
- 26 Oct 2011
- Last updated
- 19 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01687764
- Acronym / sponsor ID
- HCPA11-0249
- Keywords
- Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD), Social Anxiety Disorder (SoAD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 19 Sep 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 objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for anxiety disorders in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBGT+ABMT(active) | Experimental | Other: Attentional Bias Modification Treatment (ABMT) - Active, Behavioral: Cognitive Behavioral Group Therapy |
| CBGT+ABMT(placebo) | Experimental | Other: Attentional Bias Modification Treatment - Placebo, Behavioral: Cognitive Behavioral Group Therapy |
| PCI+ABMT(active) | Experimental | Other: Attentional Bias Modification Treatment (ABMT) - Active, Behavioral: Psychoeducational Control Intervention |
| PCI+ABMT(placebo) | Placebo comparator | Other: Attentional Bias Modification Treatment - Placebo, Behavioral: Psychoeducational Control Intervention |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview
Key exclusion criteria (3 listed)
- Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or SoAD in the clinical evaluation
- Current or previous treatment (behavioral or pharmacological) for a psychaitric disorder in childhood
- IQ < 70 (Raven)
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 |
|---|---|---|
| Attentional Bias Modification Treatment (ABMT) - ActiveThe ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor. | Other | CBGT+ABMT(active), PCI+ABMT(active) |
| Attentional Bias Modification Treatment - PlaceboThe Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation. | Other | CBGT+ABMT(placebo), PCI+ABMT(placebo) |
| Cognitive Behavioral Group Therapy"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children | Behavioural | CBGT+ABMT(active), CBGT+ABMT(placebo) |
| Psychoeducational Control InterventionPsychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities | Behavioural | PCI+ABMT(active), PCI+ABMT(placebo) |
Primary outcome
Pediatric Anxiety Rating Scale (PARS) / continuous
Time frame: Endpoint (week 10) and 6-month follow-up
Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up
Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
Time frame: Endpoint (week-10) and 6-month follow-up
Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up
6 secondary outcomes
Screen for Children and Anxiety Related Emotional Disorders (SCARED)
Time frame: Endpoint (week-10) and 6-months follow-up
Childhood Depression Inventory (CDI)
Time frame: Endpoint (week-10) and 6-month follow-up
Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)
Time frame: Endpoint (week-10) and 6-month follow-up
Spence Children's Anxiety Scale (SCAS)
Time frame: Endpoint (week-10) and 6-month follow-up
Neuropsychological measures
Time frame: Endpoint (week-10) and 6-month follow-up
Biological measures
Time frame: Endpoint (week-10) and 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
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.
Gisele G Manfro, MD, PhD principal investigator
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
Silvia H Koller, PhD principal investigator
Federal University of Rio Grande do Sul / University of Psychology
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional Bias Modification Treatment (ABMT) - Active and Cognitive Behavioral Group Therapy in people with Generalized Anxiety Disorder and Separation Anxiety Disorder, run by Hospital de Clinicas de Porto Alegre at 4 sites in 4 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia, Brazil, 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 Gisele G Manfro, MD, PhD (+55 51 3359 8983, gmanfro@portoweb.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anxiety Rating Scale (PARS) / continuous (time frame: Endpoint (week 10) and 6-month follow-up). 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?
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 19 Sep 2012.