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Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Primary Purpose

Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Attentional Bias Modification Treatment (ABMT) - Active

Attentional Bias Modification Treatment - Placebo

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Antidepressants Resistant, Attentional Bias Modification Treatment (ABMT), Attentional Retraining, Adjuvant Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary diagnosis of Generalized Anxiety Disorder, Panic Disorder or Social Anxiety Disorder according to the International Neuropsychiatric Interview psychiatric interview (M.I.N.I.)
Current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks;
Score on OASIS (Overall Anxiety Severity and Impairment Scale)equal or greater than 8

Exclusion Criteria:

Other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation
Current Cognitive Behavior Therapy
Marked intellectual disability (clinically evident)
Suicidal ideation or suicide plan at the time of assessment(M.I.N.I.)
Psychotic disorder (M.I.N.I.)
Bipolar disorder type I (M.I.N.I.)
Abuse / Dependence substances (M.I.N.I.)

Sites / Locations

Hospital de Clínicas de Porto AlegreRecruiting
Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TAU + ABMT active

TAU + AMBT placebo

Arm Description

Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor Attention Bias Modification Treatment (ABMT) - active

Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor Attention Bias Modification Treatment (ABMT) - placebo (sham)

Outcomes

Primary Outcome Measures

Overall Anxiety Severity and Impairment Scale (OASIS)

Disorder non-specific primary outcome: Score change on OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to endpoint and 3-months follow-up

Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)

Disorder-specific primary outcome: For patients with Panic Disorder - change from baseline to endpoint and 3 months follow-up in the PDSS For patients with Generalized Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the GAD-7 For patients with Social Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the LSAS

Secondary Outcome Measures

Beck Depression Inventory (BDI)

Score change on BDI from baseline to endpoint and 3-months follow up

Beck Anxiety Inventory (BAI)

Score change on BAI from baseline to endpoint and 3-months follow up

DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]

Score change on Cross-D from baseline to endpoint and 3-months follow up

Profile of Mood States (POMS)

Score Change on POMS from baseline to endpoint and 3-months follow up.

Clinical Global Impression(CGI)

Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations

Full Information

NCT ID

NCT01906268

First Posted

July 8, 2013

Last Updated

July 17, 2014

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT01906268

Brief Title

Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Official Title

Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

Brief Summary

The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

Keywords

Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Antidepressants Resistant, Attentional Bias Modification Treatment (ABMT), Attentional Retraining, Adjuvant Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TAU + ABMT active

Arm Type

Experimental

Arm Description

Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor Attention Bias Modification Treatment (ABMT) - active

Arm Title

TAU + AMBT placebo

Arm Type

Sham Comparator

Arm Description

Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor Attention Bias Modification Treatment (ABMT) - placebo (sham)

Intervention Type

Other

Intervention Name(s)

Attentional Bias Modification Treatment (ABMT) - Active

Intervention Description

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. Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)

Intervention Type

Other

Intervention Name(s)

Attentional Bias Modification Treatment - Placebo

Intervention Description

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. Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)

Primary Outcome Measure Information:

Title

Overall Anxiety Severity and Impairment Scale (OASIS)

Description

Disorder non-specific primary outcome: Score change on OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to endpoint and 3-months follow-up

Time Frame

Endpoint and 3-months follow-up

Title

Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)

Description

Time Frame

Endpoint and 3-months follow up

Secondary Outcome Measure Information:

Title

Beck Depression Inventory (BDI)

Description

Score change on BDI from baseline to endpoint and 3-months follow up

Time Frame

Endpoint and 3-months follow-up

Title

Beck Anxiety Inventory (BAI)

Description

Score change on BAI from baseline to endpoint and 3-months follow up

Time Frame

Endpoint and 3-months follow-up

Title

DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]

Description

Score change on Cross-D from baseline to endpoint and 3-months follow up

Time Frame

Endpoint and 3-months follow-up

Title

Profile of Mood States (POMS)

Description

Score Change on POMS from baseline to endpoint and 3-months follow up.

Time Frame

Endpoint and 3-months follow-up

Title

Clinical Global Impression(CGI)

Description

Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations

Time Frame

Endpoint and 3-months follow-up

Other Pre-specified Outcome Measures:

Title

Dot-probe and Executive Function Measures

Description

Change in bias in attention orienting and executive function measures from baseline to endpoint and 3-months follow-up

Time Frame

Endpoint and 3-months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary diagnosis of Generalized Anxiety Disorder, Panic Disorder or Social Anxiety Disorder according to the International Neuropsychiatric Interview psychiatric interview (M.I.N.I.) Current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks; Score on OASIS (Overall Anxiety Severity and Impairment Scale)equal or greater than 8 Exclusion Criteria: Other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation Current Cognitive Behavior Therapy Marked intellectual disability (clinically evident) Suicidal ideation or suicide plan at the time of assessment(M.I.N.I.) Psychotic disorder (M.I.N.I.) Bipolar disorder type I (M.I.N.I.) Abuse / Dependence substances (M.I.N.I.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Montagner, MD

Phone

+55 51 3359 8983

rachelmontagner@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gisele G Manfro, MD, PhD

Organizational Affiliation

Hospital de Clínicas de Porto Alegre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90040-371

Country

Brazil

Individual Site Status

Recruiting

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90040-371

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel Montagner, MD

First Name & Middle Initial & Last Name & Degree

Giovanni A Salum Junior

First Name & Middle Initial & Last Name & Degree

Juliana L Muller

First Name & Middle Initial & Last Name & Degree

Clarissa Trentini

12. IPD Sharing Statement

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Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

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