Internet Treatment for Social Phobia in Romania (iSOFIE-Ro)
Primary Purpose
Phobia, Social
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
iSOFIE
Sponsored by
About this trial
This is an interventional treatment trial for Phobia, Social focused on measuring Social anxiety disorders, Social phobia, Anxiety sensitivity, Irrational thinking, Guided self-help, Internet-delivered treatment
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
Sites / Locations
- Babes-Bolyai University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
iSOFIE
Waitlist control group
Arm Description
Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
Waitlist control group
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01557894
First Posted
March 15, 2012
Last Updated
September 5, 2014
Sponsor
Babes-Bolyai University
Collaborators
Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT01557894
Brief Title
Internet Treatment for Social Phobia in Romania
Acronym
iSOFIE-Ro
Official Title
Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University
Collaborators
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobia, Social
Keywords
Social anxiety disorders, Social phobia, Anxiety sensitivity, Irrational thinking, Guided self-help, Internet-delivered treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iSOFIE
Arm Type
Experimental
Arm Description
Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Waitlist control group
Intervention Type
Other
Intervention Name(s)
iSOFIE
Intervention Description
Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
Primary Outcome Measure Information:
Title
Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)
Description
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
Time Frame
pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Title
Social Phobia Inventory (SPIN)
Description
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
Time Frame
pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Title
Attitude and Belief Scale-II (ABS-II)
Description
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.
Time Frame
pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Title
Anxiety Sensitivity Index (ASI)
Description
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.
Time Frame
pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bogdan Tudor Tulbure, post-doc
Organizational Affiliation
Babes-Bolyai University, Romania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, Professor
Organizational Affiliation
Linköping University, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Babes-Bolyai University
City
Cluj - Napoca
State/Province
Cluj
ZIP/Postal Code
400084
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
23111108
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.
Results Reference
background
PubMed Identifier
25938241
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.
Results Reference
derived
Links:
URL
http://www.iterapi.se/sites/isofie/
Description
The public pages of the iSOFIE project (in Romanian)
Learn more about this trial
Internet Treatment for Social Phobia in Romania
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