Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

NCT01906268 | Unknown

• 1 other identifier: 13-0338
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Beck Depression Inventory (BDI)

  Endpoint and 3-months follow-up

• Beck Anxiety Inventory (BAI)

  Endpoint and 3-months follow-up

• DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]

  Endpoint and 3-months follow-up

• Profile of Mood States (POMS)

  Endpoint and 3-months follow-up

• Clinical Global Impression(CGI)

  Endpoint and 3-months follow-up

Other Outcomes (1)

• Dot-probe and Executive Function Measures

  Endpoint and 3-months follow-up

Study Arms (2)

TAU + ABMT active

EXPERIMENTAL

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

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)

Other: Attentional Bias Modification Treatment - Placebo

Interventions

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)

TAU + ABMT active

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)

TAU + AMBT placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (2)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90040-371, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90040-371, Brazil

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Panic Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gisele G Manfro, MD, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Montagner, MD

CONTACT

+55 51 3359 8983; rachelmontagner@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

BR (2)