Clinical trial NCT01557894: Internet Treatment for Social Phobia in Romania
Official title: Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia, Social
Keywords: Social anxiety disorders
Social phobia
Anxiety sensitivity
Irrational thinking
Guided self-help
Internet-delivered treatment
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2012-03-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)
timeFrame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
measure: Social Phobia Inventory (SPIN)
timeFrame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Secondary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
measure: Attitude and Belief Scale-II (ABS-II)
timeFrame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
measure: Anxiety Sensitivity Index (ASI)
timeFrame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Other outcomes:
Locations:
city: Cluj - Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
affiliation: Babes-Bolyai University, Romania
name: Bogdan Tudor Tulbure, post-doc
role: STUDY_DIRECTOR
affiliation: Linkoeping University
name: Gerhard Andersson, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.