Clinical trial NCT02338453: Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder
Official title: Examining the Effects of a Combined Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety
Attention Modification
Dot-Probe
GCBT
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Geha Mental Health Center
First posted: 2015-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores
timeFrame: 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
timeFrame: post treatment (18 weeks) and 3-month follow up
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Geha Mental Health Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Geha Mental Health Center
name: Haggai Hermesh, PhD
role: STUDY_CHAIR
References:
citation: 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.