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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iSOFIE | Experimental | Cognitive - 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iSOFIE | Other | Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bogdan Tudor Tulbure, post-doc | Babes-Bolyai University, Romania | Study Director |
| Gerhard Andersson, Professor | Linkoeping University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Babes-Bolyai University | Cluj-Napoca | Cluj | 400084 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23111108 | Background | 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. | |
| 25938241 | Derived | 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. |
| Label | URL |
|---|---|
| The public pages of the iSOFIE project (in Romanian) | View source |
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Of the 291 applicants 47 had high depression 35 had low social anxiety 38 could not be contacted 21 had long travel plans 10 declined participation 9 had other psychological disorders 8 were under 18 years 2 were redirected. Of the remaining 121 interviewed applicants, 66 meet the DSM-IV criteria for SAD, and 10 presented subclinical SAD symptoms.
The trial was briefly presented in various national and local newspapers, where a link to the project website (https://www.iterapi.se/sites/isofie) was provided. Interested participants registered online, read the informed consent, and filled in the screening questionnaires over the internet.
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| ID | Title | Description |
|---|---|---|
| FG000 | Waitlist Control Group | Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants received the active intervention. |
| FG001 | iSOFIE | Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Waitlist Control Group | Wait-list control group |
| BG001 | iSOFIE | Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Waitlist Control Group | Wait-list control group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Social Anxiety | Psychiatric disorders | Systematic Assessment | Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that social anxiety represents Other Adverse Events that occurred in all participants. |
1) An active control condition matched for clients' expectations, time, and therapist involvement was not included, 2)Due to personnel constrains, post-intervention SCID interviews were not blinded regarding the study conditions etc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bogdan Tudor Tulbure | Babes-Bolyai University | +40745753061 | btulbure@gmail.com |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| 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. | 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. | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| iSOFIE |
Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37) |
|
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|
| 0 |
| 0 |
| 38 |
| 38 |
| EG001 | iSOFIE | Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments) | 0 | 0 | 38 | 38 |
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| Six month follow up |
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| Six month follow up |
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| Six month follow up |
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| Six month follow up |
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