Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Study Overview
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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 usual treatment for anxiety disorder patients resistant to antidepressants.

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

Conditions
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Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder

Intervention / Treatment
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* Other: Attentional Bias Modification Treatment (ABMT) - Active
* Other: Attentional Bias Modification Treatment - Placebo


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + ABMT active<br>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<br>* 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)<br>|
| Sham Comparator: TAU + AMBT placebo<br>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<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Antidepressants Resistant, Attentional Bias Modification Treatment (ABMT), Attentional Retraining, Adjuvant Therapy