Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01906268
First received: July 8, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Other: Attentional Bias Modification Treatment (ABMT) - Active
Other: Attentional Bias Modification Treatment - Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]
    Score change on BDI from baseline to endpoint and 3-months follow up

  • Beck Anxiety Inventory (BAI) [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]
    Score change on BAI from baseline to endpoint and 3-months follow up

  • DSM-5 Cross-Disorder Dimensional Scale [Brazilian version] [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]
    Score change on Cross-D from baseline to endpoint and 3-months follow up

  • Profile of Mood States (POMS) [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]
    Score Change on POMS from baseline to endpoint and 3-months follow up.

  • Clinical Global Impression(CGI) [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]
    Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations


Other Outcome Measures:
  • Dot-probe and Executive Function Measures [ Time Frame: Endpoint and 3-months follow-up ] [ Designated as safety issue: No ]
    Change in bias in attention orienting and executive function measures from baseline to endpoint and 3-months follow-up


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAU + ABMT active

Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor

Attention Bias Modification Treatment (ABMT) - active

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)

Sham Comparator: TAU + AMBT placebo

Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor

Attention Bias Modification Treatment (ABMT) - placebo (sham)

Other: 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)


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906268

Contacts
Contact: Rachel Montagner, MD +55 51 3359 8983 rachelmontagner@hotmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90040-371
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90040-371
Sub-Investigator: Rachel Montagner, MD         
Sub-Investigator: Giovanni A Salum Junior         
Sub-Investigator: Juliana L Muller         
Sub-Investigator: Clarissa Trentini         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Gisele G Manfro, MD, PhD Hospital de Clínicas de Porto Alegre
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01906268     History of Changes
Other Study ID Numbers: 13-0338
Study First Received: July 8, 2013
Last Updated: July 17, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Antidepressants Resistant
Attentional Bias Modification Treatment (ABMT)
Attentional Retraining
Adjuvant Therapy

Additional relevant MeSH terms:
Anxiety Disorders
Panic Disorder
Phobic Disorders
Mental Disorders
Antidepressive Agents
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014