Overview

This trial is active, not recruiting.

Condition social anxiety disorder
Treatments active attention bias modification treatment, placebo attention bias modification treatment
Sponsor Yair Bar-Haim
Collaborator Geha Mental Health Center
Start date March 2015
End date March 2017
Trial size 40 participants
Trial identifier NCT02338453, TauGeha-001-15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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.
active attention bias modification treatment Active ABMT
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
(Placebo Comparator)
Participants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns
placebo attention bias modification treatment Placebo ABMT
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

Primary Outcomes

Measure
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores
time frame: post treatment (18 weeks) and 3-month follow up

Secondary Outcomes

Measure
Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores
time frame: post treatment (18 weeks) and 3-month follow up

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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).

Additional Information

Official title Examining the Effects of a Combined Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) for Social Anxiety Disorder
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Tel Aviv University.