Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT01906268

Collaborator

(none)

Enrollment

Locations

Arms

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Disorder Social Anxiety Disorder Panic Disorder	Other: Attentional Bias Modification Treatment (ABMT) - Active Other: Attentional Bias Modification Treatment - Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Dot-probe and Executive Function Measures [Endpoint and 3-months follow-up]
Change in bias in attention orienting and executive function measures from baseline to endpoint and 3-months follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.)