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

This study has been completed.
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Tulbure Bogdan Tudor, Babes-Bolyai University
ClinicalTrials.gov Identifier:
NCT01557894
First received: March 15, 2012
Last updated: September 5, 2014
Last verified: September 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Babes-Bolyai University:

Primary Outcome Measures:
  • 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 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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]

    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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]

    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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]

    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) [ Time Frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: April 2012
Study Completion Date: March 2013
Primary Completion Date: March 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

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557894

Locations
Romania
Babes-Bolyai University
Cluj - Napoca, Cluj, Romania, 400084
Sponsors and Collaborators
Babes-Bolyai University
Linkoeping University
Investigators
Study Director: Bogdan Tudor Tulbure, post-doc Babes-Bolyai University, Romania
Study Chair: Gerhard Andersson, Professor Linköping University, Sweden
  More Information

Additional 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
Results First Received: October 9, 2013
Last Updated: September 5, 2014
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 October 16, 2014