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Status unknownNCT01906268Updated Jul 21, 2014

Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

An interventional study of Attentional Bias Modification Treatment (ABMT) - Active and Attentional Bias Modification Treatment - Placebo in Generalized Anxiety Disorder, Social Anxiety Disorder and Panic Disorder, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 2 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-21.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Panic Disorder

Keywords

  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Panic Disorder
  • Antidepressants Resistant
  • Attentional Bias Modification Treatment (ABMT)
  • Attentional Retraining
  • Adjuvant Therapy
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherAttentional 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)

  • OtherAttentional 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)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Endpoint and 3-months follow-up

  2. 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

    Time frame: Endpoint and 3-months follow up

Secondary outcomes

  1. Beck Depression Inventory (BDI)

    Score change on BDI from baseline to endpoint and 3-months follow up

    Time frame: Endpoint and 3-months follow-up

  2. Beck Anxiety Inventory (BAI)

    Score change on BAI from baseline to endpoint and 3-months follow up

    Time frame: Endpoint and 3-months follow-up

  3. DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]

    Score change on Cross-D from baseline to endpoint and 3-months follow up

    Time frame: Endpoint and 3-months follow-up

  4. Profile of Mood States (POMS)

    Score Change on POMS from baseline to endpoint and 3-months follow up.

    Time frame: Endpoint and 3-months follow-up

  5. 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

    Time frame: Endpoint and 3-months follow-up

Other outcomes

  1. 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

    Time frame: Endpoint and 3-months follow-up

07

Study locations

2 of 2 sites recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, RS 90040-371, Brazil
    Recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, RS 90040-371, Brazil
    • Rachel Montagner, MD · Sub investigator
    • Giovanni A Salum Junior · Sub investigator
    • Juliana L Muller · Sub investigator
    • Clarissa Trentini · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01906268
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Jul 24, 2013
Start date
Jul 2013
Primary completion
Dec 2014 (estimated)
Last update
Jul 21, 2014

Study contacts

Rachel Montagner, MD
Contact
rachelmontagner@hotmail.com
+55 51 3359 8983
Gisele G Manfro, MD, PhD
principal investigator · Hospital de Clínicas de Porto Alegre
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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