Internet Treatment for Social Phobia in Romania

NCT01557894 | Completed Results

• 1 other identifier: TTudor
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia, Social

Keywords

Social anxiety disorders; Social phobia; Anxiety sensitivity; Irrational thinking; Guided self-help; Internet-delivered treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Beck Depression Inventory-II (BDI-II)

  pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)

• Attitude and Belief Scale-II (ABS-II)

  pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)

• Anxiety Sensitivity Index (ASI)

  pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)

Study Arms (2)

iSOFIE

EXPERIMENTAL

Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)

Other: iSOFIE

Waitlist control group

NO INTERVENTION

Waitlist control group

Interventions

iSOFIE OTHER

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

iSOFIE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Babes-Bolyai University: lead
• Linkoeping University: collaborator

Study Sites (1)

Babes-Bolyai University

Cluj-Napoca, Cluj, 400084, Romania

Location

Related Publications (2)

• 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.

  PMID: 23111108 BACKGROUND

• 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.

  PMID: 25938241 DERIVED

Related Links

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

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Limitations and Caveats

1\) An active control condition matched for clients' expectations, time, and therapist involvement was not included, 2)Due to personnel constrains, post-intervention SCID interviews were not blinded regarding the study conditions etc.

Results Point of Contact

• Title: Bogdan Tudor Tulbure
• Organization: Babes-Bolyai University

btulbure@gmail.com

+40745753061

Study Officials

• Bogdan Tudor Tulbure, post-doc

  Babes-Bolyai University, Romania

  STUDY DIRECTOR

• Gerhard Andersson, Professor

  Linkoeping University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post-doctoral researcher

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 17, 2014
• Results First Posted: August 12, 2014

Record last verified: 2014-09

Locations

RO (1)