An interventional study of iSOFIE in Phobia, Social, sponsored by Babes-Bolyai University. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-17.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment
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.
135 studies on the registry are indexed under Phobic Disorders; 16 are open to participants now.
This study's enrollment of 76 is above the median of 68 across 122 interventional studies indexed under Phobic Disorders.
Browse Phobic Disorders studies →Babes-Bolyai University is the lead sponsor of 48 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
Other: iSOFIE
Waitlist control group
Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
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
Time frame: 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
Time frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
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.
Time frame: 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.
Time frame: 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.
Time frame: pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
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.
| Milestone | Waitlist Control Group | iSOFIE |
|---|---|---|
| Started | 38 | 38 |
| Completed | 35 | 33 |
| Not completed | 3 | 5 |
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
| units on a scale | Waitlist Control Group | iSOFIE |
|---|---|---|
| Pre-intervention assessment | 78.60 ± 16.14 | 78.47 ± 21.78 |
| Post-intervention assessment | 73.69 ± 26.46 | 43.98 ± 23.17 |
| Six month follow up | NA ± NA | 35.77 ± 25.44 |
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
| units on a scale | Waitlist Control Group | iSOFIE |
|---|---|---|
| Pre-intervention assessment | 45.50 ± 9.45 | 45.15 ± 9.69 |
| Post-intervention assessment | 43.22 ± 10.94 | 27.95 ± 13.04 |
| Six month follow up | NA ± NA | 19.74 ± 13.00 |
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.
| units on a scale | Waitlist Control Group | iSOFIE |
|---|---|---|
| Pre-intervention assessment | 15.39 ± 6.99 | 15.15 ± 7.47 |
| Post-intervention assessment | 12.77 ± 7.27 | 7.25 ± 5.95 |
| Six month follow up | NA ± NA | 6.44 ± 7.05 |
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.
| units on a scale | Waitlist Control Group | iSOFIE |
|---|---|---|
| Pre-intervention assessment | 124.60 ± 41.50 | 120.94 ± 39.78 |
| Post-intervention assessment | 102.51 ± 46.62 | 76.62 ± 34.81 |
| Six month follow up | NA ± NA | 57.96 ± 31.67 |
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.
| units on a scale | Waitlist Control Group | iSOFIE |
|---|---|---|
| Pre-intervention assessment | 29.00 ± 9.58 | 29.28 ± 11.40 |
| Post-intervention assessment | 26.17 ± 10.26 | 18.38 ± 10.34 |
| Six month follow up | NA ± NA | 13.40 ± 9.40 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Waitlist Control Group | — | — | 38/38 (100%) |
| iSOFIE | — | — | 38/38 (100%) |
| Event | Waitlist Control Group | iSOFIE |
|---|---|---|
| Social AnxietyPsychiatric disorders | 38/38 | 38/38 |
| Age, Categorical(Participants) | Waitlist Control Group | iSOFIE | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 38 | 38 | 76 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Waitlist Control Group | iSOFIE | Total |
|---|---|---|---|
| Mean | 27.85 ± 7.83 | 30.57 ± 7.96 | 28.82 ± 8.04 |
| Sex: Female, Male(Participants) | Waitlist Control Group | iSOFIE | Total |
|---|---|---|---|
| Female | 23 | 22 | 45 |
| Male | 15 | 16 | 31 |
| Region of Enrollment(participants) | Waitlist Control Group | iSOFIE | Total |
|---|---|---|---|
| Romania | 38 | 38 | 76 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Babes-Bolyai University