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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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)
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)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGHospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGOverall 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
Time frame: 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
Time frame: Endpoint and 3-months follow up
Beck Depression Inventory (BDI)
Score change on BDI from baseline to endpoint and 3-months follow up
Time frame: Endpoint and 3-months follow-up
Beck Anxiety Inventory (BAI)
Score change on BAI from baseline to endpoint and 3-months follow up
Time frame: 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
Time frame: Endpoint and 3-months follow-up
Profile of Mood States (POMS)
Score Change on POMS from baseline to endpoint and 3-months follow up.
Time frame: Endpoint and 3-months follow-up
Clinical Global Impression(CGI)
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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