Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90040-371
      • Recruiting
      • Hospital de Clínicas de Porto Alegre
      • Sub-Investigator: Rachel Montagner, MD
      • Sub-Investigator: Giovanni A Salum Junior
      • Sub-Investigator: Juliana L Muller
      • Sub-Investigator: Clarissa Trentini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAU + ABMT active; Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor Attention Bias Modification Treatment (ABMT) - active	Other: 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. Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)
Sham Comparator: TAU + AMBT placebo; Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor Attention Bias Modification Treatment (ABMT) - placebo (sham)	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. Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Endpoint and 3-months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory (BDI)	Score change on BDI from baseline to endpoint and 3-months follow up	Endpoint and 3-months follow-up
Beck Anxiety Inventory (BAI)	Score change on BAI from baseline to endpoint and 3-months follow up	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	Endpoint and 3-months follow-up
Profile of Mood States (POMS)	Score Change on POMS from baseline to endpoint and 3-months follow up.	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	Endpoint and 3-months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dot-probe and Executive Function Measures	Change in bias in attention orienting and executive function measures from baseline to endpoint and 3-months follow-up	Endpoint and 3-months follow-up

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Gisele G Manfro, MD, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: July 17, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; Panic Disorder; Social Anxiety Disorder; Adjuvant Therapy; Antidepressants Resistant; Attentional Bias Modification Treatment (ABMT); Attentional Retraining
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social; Panic Disorder
• Other Study ID Numbers: 13-0338