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

NCT ID: NCT01687764

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Generalized Anxiety Disorder Separation Anxiety Disorder Social Anxiety Disorder

Keywords

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Generalized Anxiety Disorder (GAD) Separation Anxiety Disorder (SeAD) Social Anxiety Disorder (SoAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CBGT+ABMT(active)

Group Type EXPERIMENTAL

Attentional Bias Modification Treatment (ABMT) - Active

Intervention Type OTHER

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.

Cognitive Behavioral Group Therapy

Intervention Type BEHAVIORAL

"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children

CBGT+ABMT(placebo)

Group Type EXPERIMENTAL

Attentional Bias Modification Treatment - Placebo

Intervention Type OTHER

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 Therapy

Intervention Type BEHAVIORAL

"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children

PCI+ABMT(active)

Group Type EXPERIMENTAL

Attentional Bias Modification Treatment (ABMT) - Active

Intervention Type OTHER

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.

Psychoeducational Control Intervention

Intervention Type BEHAVIORAL

Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

PCI+ABMT(placebo)

Group Type PLACEBO_COMPARATOR

Attentional Bias Modification Treatment - Placebo

Intervention Type OTHER

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.

Psychoeducational Control Intervention

Intervention Type BEHAVIORAL

Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

Interventions

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Attentional Bias Modification Treatment (ABMT) - Active

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.

Intervention Type OTHER

Attentional Bias Modification Treatment - Placebo

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.

Intervention Type OTHER

Cognitive Behavioral Group Therapy

"FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children

Intervention Type BEHAVIORAL

Psychoeducational Control Intervention

Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gisele G Manfro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre

Silvia H Koller, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul / University of Psychology

Locations

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National Institute of Mental Health (NIMH)

Bethesda, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

University of Queensland

Brisbane Saint Lucia, Queensland, Australia

Site Status ACTIVE_NOT_RECRUITING

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Tel-Aviv University

Tel Aviv, , Israel

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Australia Brazil Israel

Central Contacts

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Gisele G Manfro, MD, PhD

Role: CONTACT

Phone: +55 51 3359 8983

Email: [email protected]

Giovanni A Salum Junior, MD

Role: CONTACT

Phone: +55 51 3359 8983

Email: [email protected]

Facility Contacts

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Giovanni A Salum Junior, MD

Role: primary

Rafaela Behs, MSc

Role: backup

Other Identifiers

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HCPA11-0249

Identifier Type: -

Identifier Source: org_study_id