Internet Treatment for Social Phobia in Romania (iSOFIE-Ro)

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

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.

Study Overview

• Status: Completed
• Conditions: Phobia, Social
• Intervention / Treatment: Other: iSOFIE

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj - Napoca, Cluj, Romania, 400084
      • Babeș-Bolyai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iSOFIE; Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)	Other: iSOFIE; Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
NO_INTERVENTION: Waitlist control group

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Babes-Bolyai University
• Collaborators: Linkoeping University
• Investigators: Study Director: Bogdan Tudor Tulbure, post-doc, Babes-Bolyai University, Romania; Study Chair: Gerhard Andersson, Professor, Linköping University, Sweden

Publications and helpful links

General Publications

• Tulbure BT, Mansson 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.
• Tulbure BT, Szentagotai A, David O, Stefan S, Mansson KN, David D, Andersson G. Internet-delivered cognitive-behavioral therapy for social anxiety disorder in Romania: a randomized controlled trial. PLoS One. 2015 May 4;10(5):e0123997. doi: 10.1371/journal.pone.0123997. eCollection 2015.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: March 16, 2012
• First Posted (ESTIMATE): March 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 5, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Social phobia; Anxiety sensitivity; Guided self-help; Social anxiety disorders; Irrational thinking; Internet-delivered treatment
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: TTudor