Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder

NCT02338453 | Completed

• 1 other identifier: TauGeha-001-15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This RCT examines the effectiveness of Attention Bias Modification Treatment (ABMT) as an augment to Cognitive-Behavioral Group Treatment (CBGT) for Social Anxiety Disorder (SAD) in adults. It is expected that ABMT vs. control training condition would achieve better therapeutic outcomes as indicated reduction in symptoms. Participants from three groups (estimated 40 patients) will be offered to participate in the study

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety; Attention Modification; Dot-Probe; GCBT

Outcome Measures

Primary Outcomes (1)

• Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores

  The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern (Safren et al., 1999). It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability (Fresco et al., 2001; Heimberg et al., 1999)

  post treatment (18 weeks) and 3-month follow up

Secondary Outcomes (1)

• Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores

  post treatment (18 weeks) and 3-month follow up

Study Arms (2)

Attention Bias Modification Treatment

ACTIVE COMPARATOR

Participants will receive an attention bias modification protocol designed to divert attention away from socially-threatening stimuli via repeated trials of a dot-probe task.

Behavioral: Active Attention Bias Modification Treatment

placebo-control condition

PLACEBO COMPARATOR

Participants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns

Behavioral: Placebo Attention Bias Modification Treatment

Interventions

Active Attention Bias Modification Treatment BEHAVIORAL

Attention bias is modified using a dot-probe task. Each trial begins with a fixation cross presented in the center of the screen for 500 ms. Next, participants are presented with two stimuli depicting two faces of the same individual for 500 ms, either of two neutral faces or with one neutral face and one disgust face (i.e., the socially-threatening stimulus). Then, one of two optional probes appears in the location former occupied by one of the faces. Participants are instructed to discriminate as fast as possible between the two variants of the probe, without compromising accuracy, by pressing on two corresponding keys. The probe remains on the screen until the participant responds, after which the next trial commences. This protocol is designed to divert attention away from socially-threatening stimuli as in 80% of trials the probe appears in the location formerly occupied by the neutral face. The remaining 20% of trials include two neutral faces, with no predictive value

Also known as: Active ABMT

Attention Bias Modification Treatment

Placebo Attention Bias Modification Treatment BEHAVIORAL

the Placebo ABMT is similar to the active ABMT except that this protocol is not designed to divert attention away from or toward socially-threatening stimuli as in 40% of trials the probe appears in the location formerly occupied by the neutral face and in 40% it appears in the location formally occupied by the threatening face. The remaining 20% of trials include two neutral faces

Also known as: Placebo ABMT

placebo-control condition

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A signed consent form
• Men and women between the ages of 18 and 60.
• Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
• A minimum of a 1-year duration of SP
• SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
• Stable pharmacotherapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of CBGT.

You may not qualify if:

• Psychotic episode in the past or the present time.
• Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
• Another psychotherapeutic treatment during the study.
• Usage of neuroleptic medication.
• Change in medication status during the study.
• Substantial usage of drugs or alcohol in the present time.
• Poor judgment capacity (i.e., children under 18 and special populations).

Sponsors & Collaborators

• Yair Bar-Haim: lead
• Geha Mental Health Center: collaborator

Study Sites (2)

Geha Mental Health Center

Petah Tikva, Israel

Location

Tel-Aviv University

Tel Aviv, Israel

Location

Related Publications (1)

• Shechner T, Rimon-Chakir A, Britton JC, Lotan D, Apter A, Bliese PD, Pine DS, Bar-Haim Y. Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):61-71. doi: 10.1016/j.jaac.2013.09.016. Epub 2013 Oct 10.

  PMID: 24342386 BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Haggai Hermesh, PhD

  Geha Mental Health Center

  STUDY CHAIR

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 INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 14, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

IL (2)