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Completed

NCT Number: NCT01557894

Internet Treatment for Social Phobia in Romania

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.

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Key information

Conditions

Phobia, Social Anxiety Disorders Mental Disorders Phobic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Babes-Bolyai University

Cluj-Napoca, Cluj, 400084, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iSOFIE

Other

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

Primary outcomes

  1. Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)

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

    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

  2. Social Phobia Inventory (SPIN)

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

    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 outcomes

  1. Beck Depression Inventory-II (BDI-II)

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

    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.

  2. Attitude and Belief Scale-II (ABS-II)

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

    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.

  3. Anxiety Sensitivity Index (ASI)

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

    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.

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial

Acronym: iSOFIE-Ro

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2012
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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