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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

H

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Generalized Anxiety Disorder
Social Anxiety Disorder
Separation Anxiety Disorder

Treatments

Other: Attentional Bias Modification Treatment (ABMT) - Active
Other: Attentional Bias Modification Treatment - Placebo
Behavioral: Psychoeducational Control Intervention
Behavioral: Cognitive Behavioral Group Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01687764
HCPA11-0249

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

90 participants in 4 patient groups, including a placebo group

CBGT+ABMT(active)
Experimental group
Treatment:
Behavioral: Cognitive Behavioral Group Therapy
Other: Attentional Bias Modification Treatment (ABMT) - Active
CBGT+ABMT(placebo)
Experimental group
Treatment:
Behavioral: Cognitive Behavioral Group Therapy
Other: Attentional Bias Modification Treatment - Placebo
PCI+ABMT(active)
Experimental group
Treatment:
Behavioral: Psychoeducational Control Intervention
Other: Attentional Bias Modification Treatment (ABMT) - Active
PCI+ABMT(placebo)
Placebo Comparator group
Treatment:
Behavioral: Psychoeducational Control Intervention
Other: Attentional Bias Modification Treatment - Placebo

Trial contacts and locations

4

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Central trial contact

Gisele G Manfro, MD, PhD; Giovanni A Salum Junior, MD

Data sourced from clinicaltrials.gov

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