Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Not Applicable

• Conditions: Panic Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder
• Interventions: Other: Attentional Bias Modification Treatment (ABMT) - Active; Other: Attentional Bias Modification Treatment - Placebo

• Registration Number: NCT01906268
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-24
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-21
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU + ABMT active	Attentional Bias Modification Treatment (ABMT) - Active	Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor Attention Bias Modification Treatment (ABMT) - active
TAU + AMBT placebo	Attentional Bias Modification Treatment - Placebo	Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor Attention Bias Modification Treatment (ABMT) - placebo (sham)

Primary Outcome Measures

Name	Time	Method
Overall Anxiety Severity and Impairment Scale (OASIS)	Endpoint and 3-months follow-up	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)	Endpoint and 3-months follow up	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

Name	Time	Method
Beck Depression Inventory (BDI)	Endpoint and 3-months follow-up	Score change on BDI from baseline to endpoint and 3-months follow up
Beck Anxiety Inventory (BAI)	Endpoint and 3-months follow-up	Score change on BAI from baseline to endpoint and 3-months follow up
DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]	Endpoint and 3-months follow-up	Score change on Cross-D from baseline to endpoint and 3-months follow up
Profile of Mood States (POMS)	Endpoint and 3-months follow-up	Score Change on POMS from baseline to endpoint and 3-months follow up.
Clinical Global Impression(CGI)	Endpoint and 3-months follow-up	Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil