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

Yair Bar-Haim

Status: Completed

Conditions: Social Anxiety Disorder

Treatments: Behavioral: Active Attention Bias Modification Treatment; Behavioral: Placebo Attention Bias Modification Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02338453

TauGeha-001-15

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Attention Bias Modification Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active Attention Bias Modification Treatment

placebo-control condition

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Placebo Attention Bias Modification Treatment