Phobia, SocialiSOFIE-RoNCT01557894
Internet Treatment for Social Phobia in Romania
A study testing iSOFIE in people with Phobia, Social, run by Babes-Bolyai University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phobia, Social
- What is being tested?
- iSOFIE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Phobia, Social
- Being tested
- iSOFIE
- Keywords
- Social anxiety disorders, Social phobia, Anxiety sensitivity, Irrational thinking, Guided self-help, Internet-delivered treatment
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSOFIEOther
Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
| Study group | Role | What they receive |
|---|---|---|
| iSOFIE | Experimental | Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) Receives: Other: iSOFIE |
| Waitlist control group | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Secondary outcomes (3)
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.
Measured: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
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.
Measured: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
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.
Measured: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phobia, SocialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Tulbure Bogdan Tudor, Babes-Bolyai University
- Investigators
- Bogdan Tudor Tulbure, post-doc, Study director, Babes-Bolyai University, RomaniaGerhard Andersson, Professor, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557894
- Sponsor's protocol ID
- TTudor
- Acronym
- iSOFIE-Ro
- Status last verified
- Sep 2014
- First submitted
- 15 Mar 2012
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23111108Tulbure 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.
PubMed 25938241
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01557894
- Acronym / sponsor ID
- iSOFIE-Ro / TTudor
- Conditions
- Phobia, Social
- Keywords
- Social anxiety disorders, Social phobia, Anxiety sensitivity, Irrational thinking, Guided self-help, Internet-delivered treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Posted 12 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iSOFIE | Experimental | Other: iSOFIECognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) |
| Waitlist control group | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSOFIECognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) | Other | iSOFIE |
Primary outcome
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
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
3 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Attitude and Belief Scale-II (ABS-II)
Time frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Anxiety Sensitivity Index (ASI)
Time frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23111108Tulbure 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.
- Derived from this study: PubMed 25938241Tulbure 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.
- The public pages of the iSOFIE project (in Romanian)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan Tudor Tulbure, post-doc study director
Babes-Bolyai University, Romania
Gerhard Andersson, Professor study chair
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSOFIE in people with Phobia, Social, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (time frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.