Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder (ABMT+CBGT)
Primary Purpose
Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Active Attention Bias Modification Treatment
Placebo Attention Bias Modification Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety, Attention Modification, Dot-Probe, GCBT
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).
Sites / Locations
- Geha Mental Health Center
- Tel-Aviv University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Attention Bias Modification Treatment
placebo-control condition
Arm 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.
Participants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns
Outcomes
Primary Outcome Measures
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores
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
Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores
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).
Full Information
NCT ID
NCT02338453
First Posted
January 7, 2015
Last Updated
August 17, 2017
Sponsor
Yair Bar-Haim
Collaborators
Geha Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT02338453
Brief Title
Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder
Acronym
ABMT+CBGT
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yair Bar-Haim
Collaborators
Geha Mental Health Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety, Attention Modification, Dot-Probe, GCBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention Bias Modification Treatment
Arm Type
Active Comparator
Arm 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.
Arm Title
placebo-control condition
Arm Type
Placebo Comparator
Arm Description
Participants will receive an placebo control protocol using the same task and stimuli but not designed to change attention patterns
Intervention Type
Behavioral
Intervention Name(s)
Active Attention Bias Modification Treatment
Other Intervention Name(s)
Active ABMT
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Placebo Attention Bias Modification Treatment
Other Intervention Name(s)
Placebo ABMT
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview (LSAS; Liebowitz, 1987) scores
Description
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)
Time Frame
post treatment (18 weeks) and 3-month follow up
Secondary Outcome Measure Information:
Title
Change from baseline - the Social Phobia Inventory (SPIN; Connor et al., 2000) scores
Description
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).
Time Frame
post treatment (18 weeks) and 3-month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haggai Hermesh, PhD
Organizational Affiliation
Geha Mental Health Center
Official's Role
Study Chair
Facility Information:
Facility Name
Geha Mental Health Center
City
Petah-Tikva
Country
Israel
Facility Name
Tel-Aviv University
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
24342386
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.
Results Reference
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Attention Bias Modification Treatment (ABMT) and Cognitive-Behavioral Group Therapy (CBGT) in Social Anxiety Disorder
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