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NCT Number: NCT02338453

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

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

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geha Mental Health Center, Petah Tikva, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other names: Active ABMT

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

Other names: Placebo ABMT

Primary outcomes

  1. 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

    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 outcomes

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yair Bar-Haim

Other

Collaborators

  • Geha Mental Health Center

Registry information

Official study title

Examining the Effects of a Combined Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) for Social Anxiety Disorder

Acronym: ABMT+CBGT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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