Clinical trial NCT01906268: Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants
Official title: Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Keywords: Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Antidepressants Resistant
Attentional Bias Modification Treatment (ABMT)
Attentional Retraining
Adjuvant Therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Endpoint and 3-months follow-up
measure: Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Endpoint and 3-months follow up
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: Endpoint and 3-months follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: Endpoint and 3-months follow-up
measure: DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]
timeFrame: Endpoint and 3-months follow-up
measure: Profile of Mood States (POMS)
timeFrame: Endpoint and 3-months follow-up
measure: Clinical Global Impression(CGI)
timeFrame: Endpoint and 3-months follow-up
Other outcomes:
measure: Dot-probe and Executive Function Measures
timeFrame: Endpoint and 3-months follow-up
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Gisele G Manfro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: