Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder
Conditions
Keywords
Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Antidepressants Resistant, Attentional Bias Modification Treatment (ABMT), Attentional Retraining, Adjuvant Therapy
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.
Interventions
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)
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Profile of Mood States (POMS) | Endpoint and 3-months follow-up | Score Change on POMS from baseline to endpoint and 3-months follow up. |
| Beck Depression Inventory (BDI) | Endpoint and 3-months follow-up | Score change on BDI from baseline to endpoint and 3-months follow up |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactRachel Montagner, MD
Outcome results
None listed