Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Generalized Anxiety Disorder
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Overall Anxiety Severity and Impairment Scale (OASIS)
- Last Updated
- 11 years ago
Overview
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.
Investigators
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.)
Outcomes
Primary Outcomes
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: 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)
Time Frame: 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 Outcomes
- Beck Depression Inventory (BDI)(Endpoint and 3-months follow-up)
- Beck Anxiety Inventory (BAI)(Endpoint and 3-months follow-up)
- DSM-5 Cross-Disorder Dimensional Scale [Brazilian version](Endpoint and 3-months follow-up)
- Profile of Mood States (POMS)(Endpoint and 3-months follow-up)
- Clinical Global Impression(CGI)(Endpoint and 3-months follow-up)