Cognitive Biases Modification Treatment for Social Anxiety (CBMSP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01503151|
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : December 2, 2014
Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.
Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria.
The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.
|Condition or disease||Intervention/treatment||Phase|
|Social Phobia||Behavioral: Attention Bias Modification Treatment (ABMT) Behavioral: Interpretation Bias Modification (IBM) Behavioral: Control Condition Behavioral: Attention and Interpretive biases modification (CBM)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Cognitive Biases Modification Treatment for Social Anxiety|
|Study Start Date :||January 2012|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Placebo Comparator: Placebo
repeated trials of a dot-probe task and repeated trials of an interpretation task, both not intended to change threat-related biases patterns.
Behavioral: Control Condition
Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
Experimental: Attention Bias Modification (ABM)
Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
Behavioral: Attention Bias Modification Treatment (ABMT)
Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
Experimental: Interpretation Bias Modification (IBM)
Interpretation training intended to facilitating a more benign interpretation bias
Behavioral: Interpretation Bias Modification (IBM)
Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
Experimental: Attention and interpretation biases modification
Attention and interpretation training intended to direct cognitive biases away from threat stimulus.
Behavioral: Attention and Interpretive biases modification (CBM)
Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.
- Social Anxiety Scale (LSAS) - diagnostic interview [ Time Frame: Expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols ]LSAS is a 24-items clinician-administered scale developed for the assessment of fear and avoidance associated with social. The LSAS assesses a wide range of both social interaction and performance/observation situations, which are rated for degree of fear/anxiety and frequency of avoidance.
- The Mini International Neuropsychiatric Interview (MINI). [ Time Frame: expected time frame of 6 weeks per participant. Participants will be assessed before and after the administration of the training/control protocols ]The Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview (DSI) developed to explore 17 disorders according to Diagnostic and Statistical Manual diagnostic criteria (DSM)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503151