Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

Generalized Anxiety Disorder Clinical Trial

Official title:

Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01906268
• Other study ID #: 13-0338
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2013
• Last updated: July 17, 2014
• Start date: July 2013

Study information

• Verified date: July 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Rachel Montagner, MD
• Phone: +55 51 3359 8983
• Email: rachelmontagner[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder
• Panic Disorder
• Phobic Disorders
• Social Anxiety Disorder

Intervention

Other:
• Attentional Bias Modification Treatment (ABMT) - Active
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)
• Attentional Bias Modification Treatment - Placebo
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)

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Primary	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	No
Secondary	Beck Depression Inventory (BDI)	Score change on BDI from baseline to endpoint and 3-months follow up	Endpoint and 3-months follow-up	No
Secondary	Beck Anxiety Inventory (BAI)	Score change on BAI from baseline to endpoint and 3-months follow up	Endpoint and 3-months follow-up	No
Secondary	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	No
Secondary	Profile of Mood States (POMS)	Score Change on POMS from baseline to endpoint and 3-months follow up.	Endpoint and 3-months follow-up	No
Secondary	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	No