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

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Active Attention Bias Modification Treatment; Behavioral: Placebo Attention Bias Modification Treatment

• Registration Number: NCT02338453
• Lead Sponsor: Yair Bar-Haim

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

Detailed Description

Outpatients seeking treatment for Social Anxiety Disorder (SAD) at Geha anxiety-disorders clinic will be randomized into two groups (ABMT+CBGT; placebo control+CBGT). One group will undergo an Attention Bias Modification Treatment (ABMT) aimed at diverting attention away from socially-threatening stimuli. The second group will receive a placebo-control not designed to affect attention. Both groups will also undergo a standard Cognitive-Behavioral Group Treatment (CBGT) comprising 18 weekly sessions of 1.5-hr duration (along the lines of Heimberg, Juster, Hope \& Mattia 1995 and Clark \& Wells 1995). Symptoms and attention bias measures will be taken at three time points: Pre-treatment, Post-treatment,and at 3-month follow-up.

The study includes the following steps: a) initial assessment of participants' psychopathology and symptom levels; b) attention bias measurement; c) 8 sessions of ABMT/placebo control delivered as part of the CBGT sessions; d) two booster ABMT/Placebo treatments will be delivered at sessions 13 and 16 of the CBGT protocol. e) post-treatment assessment will include symptom and attention bias assessments. Finally, f) a three-month follow up assessment.

The goal of the study is to to test the effectiveness of ABMT as an add-on to established CBGT protocol for social anxiety disorder.

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-11
• Study First Posted: 2015-01-14
• Study Start: 2015-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Bias Modification Treatment	Active Attention Bias Modification Treatment	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.
placebo-control condition	Placebo Attention Bias Modification Treatment	Participants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns

Primary Outcome Measures

Name	Time	Method
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores	post treatment (18 weeks) and 3-month follow up	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)

Secondary Outcome Measures

Name	Time	Method
Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores	post treatment (18 weeks) and 3-month follow up	This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68. The SPIN has been used in clinical and nonclinical samples and its psychometric properties have been found to be sound (Connor et al., 2000).

Trial Locations

Locations (2)

Tel-Aviv University; 🇮🇱 Tel-Aviv, Israel

Geha Mental Health Center; 🇮🇱 Petah-Tikva, Israel