Internet Treatment for Social Phobia in Romania

Phobia, Social Clinical Trial

— iSOFIE-Ro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557894
• Other study ID #: TTudor
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: September 5, 2014
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobia, Social
• Phobic Disorders

Intervention

Other:
• iSOFIE
Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)

Locations

Country	Name	City	State
Romania	Babes-Bolyai University	Cluj - Napoca	Cluj

Sponsors (2)

Lead Sponsor	Collaborator
Babes-Bolyai University	Linkoeping University

Country where clinical trial is conducted

Romania, 

References & Publications (1)

Tulbure BT, Månsson KN, Andersson G. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial. Trials. 2012 Oct 30;13:202. doi: 10.1186/1745-6215-13-202. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   The public pages of the iSOFIE project (in Romanian)