Internet Treatment for Social Phobia (iSOFIE-Ro)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Phobia, Social |
Other: iSOFIE Other: Waitlist control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Internet Treatment for Social Phobia: A Randomized Controlled Trial |
- Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]The LSAS is expected to report a change from week 0 to week 11, and week 37.
- Social Phobia Inventory (SPIN) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]The SPIN is expected to report a change from week 0 to week 11, and week 37.
- Beck Depression Inventory-II (BDI-II) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]
- Attitude and Belief Scale-II (ABS-II) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]
- Anxiety Sensitivity Index (ASI) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]
- Social Interaction and Anxiety Scale (SIAS) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]
- Social Phobia Screening Questionnaire (SPSQ) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Waitlist control group
|
Other: Waitlist control group
Waitlist control group
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Bogdan Tudor Tulbure, post-doc | 0040745753061 | btulbure@gmail.com , bogdan.tulbure@ubbcluj.ro |
| Contact: Gerhard Andersson, Professor | 0046 013 285840 | Gerhard.Andersson@liu.se |
| Romania | |
| Babes-Bolyai University | Not yet recruiting |
| Cluj - Napoca, Cluj, Romania, 400084 | |
| Contact: Bogdan Tudor Tulbure, post-doc 0040745753061 btulbure@gmail.com , bogdan.tulbure@ubbcluj.ro | |
| Contact: Gerhard Andersson, Professor 0046 013 285840 Gerhard.Andersson@liu.se | |
| Study Director: | Bogdan Tudor Tulbure, post-doc | Babes-Bolyai University, Romania |
| Study Chair: | Gerhard Andersson, Professor | Linköping University, Sweden |
More Information
No publications provided by Babes-Bolyai University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tulbure Bogdan Tudor, post-doctoral researcher, Babes-Bolyai University |
| ClinicalTrials.gov Identifier: | NCT01557894 History of Changes |
| Other Study ID Numbers: | TTudor |
| Study First Received: | March 15, 2012 |
| Last Updated: | March 16, 2012 |
| Health Authority: | Romania: Ethics Committee |
Keywords provided by Babes-Bolyai University:
|
Social anxiety disorders Social phobia Anxiety sensitivity |
Irrational thinking Guided self-help Internet-delivered treatment |
Additional relevant MeSH terms:
|
Phobic Disorders Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013