Internet Treatment for Social Phobia in Romania

Study Overview
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Brief Summary
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The main aim of this study is to investigate the effectiveness of an Internet-delivered intervention for social phobia by comparing it to a waitlist control group. The second aim of the study is to track the potential changes in participants' thinking patterns. Because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility will also be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.

Detailed Description
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The primary aim of this study is to investigate the effectiveness of an internet intervention for social phobia (i.e., the iSOFIE) by comparing it to a waitlist control group. iSOFIE was derived from a previously tested program (Furmark, Holmström, Sparthan, Carlbring, & Andersson, 2006) and has been significantly shortened while retaining the most important elements. The second aim of the study is to track the potential changes in participants' thinking patterns. While this intervention is primarily based on the cognitive-behavioral model of SAD (Clark and Wells, 1995), and no specific Rational Emotive Behavior Therapy (REBT, Ellis & Dryden, 1997) will be implemented, it is hypothesized that the cognitive restructuring and exposure exercises will make participants less prone to irrational thinking (as measured by the Attitude and Belief Scale-II (ABS-II, DiGiuseppe, Leaf, Exner, & Robin, 1988). To our knowledge, no study has investigated whether an iCBT program for SAD has the potential to alter participants' irrational thinking patterns. Moreover, because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility of the program will be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.

Official Title
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Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial

Conditions
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Phobia, Social

Intervention / Treatment
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* Other: iSOFIE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years social anxiety disorder is the primary diagnostic (according to the DSM-IV) access to an Internet connected computer be fluent in Romanian language Exclusion Criteria: suicidal ideation ongoing psychological treatment for social anxiety disorder recent change in psychiatric medication (i.e., during the last 6 weeks) psychoses or borderline personality disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iSOFIE<br>Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) | Other: iSOFIE<br>* Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)<br>|
| No Intervention: Waitlist control group<br>Waitlist control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) | The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety. LSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation. In order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together. The LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) | 
| Social Phobia Inventory (SPIN) | The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale. Thus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II (BDI-II) | Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0-3, indicating increasing symptom severity. Thus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression. | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) | 
| Attitude and Belief Scale-II (ABS-II) | The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population. The total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality. | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) | 
| Anxiety Sensitivity Index (ASI) | The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity. | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social anxiety disorders, Social phobia, Anxiety sensitivity, Irrational thinking, Guided self-help, Internet-delivered treatment