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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU + ABMT active | Experimental | Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor Attention Bias Modification Treatment (ABMT) - active |
|
| TAU + AMBT placebo | Sham Comparator | Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor Attention Bias Modification Treatment (ABMT) - placebo (sham) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attentional Bias Modification Treatment (ABMT) - Active | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall 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 | 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 | Endpoint and 3-months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory (BDI) | Score change on BDI from baseline to endpoint and 3-months follow up | Endpoint and 3-months follow-up |
| Beck Anxiety Inventory (BAI) | Score change on BAI from baseline to endpoint and 3-months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Dot-probe and Executive Function Measures | Change in bias in attention orienting and executive function measures from baseline to endpoint and 3-months follow-up | Endpoint and 3-months follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Montagner, MD | Contact | +55 51 3359 8983 | rachelmontagner@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gisele G Manfro, MD, PhD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90040-371 | Brazil | |
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|
| Attentional Bias Modification Treatment - Placebo | Other | 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) |
|
| 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 | Endpoint and 3-months follow-up |
| Profile of Mood States (POMS) | Score Change on POMS from baseline to endpoint and 3-months follow up. | Endpoint and 3-months follow-up |
| Clinical Global Impression(CGI) | Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations | Endpoint and 3-months follow-up |
| Hospital de Clínicas de Porto Alegre |
| Recruiting |
| Porto Alegre |
| Rio Grande do Sul |
| 90040-371 |
| Brazil |
|
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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