Trial Outcomes & Findings for Internet Treatment for Social Phobia in Romania (NCT NCT01557894)
NCT ID: NCT01557894
Last Updated: 2014-09-17
Results Overview
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
COMPLETED
NA
76 participants
pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)
2014-09-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Internet Treatment for Social Phobia in Romania
Baseline characteristics by cohort
| Measure |
Waitlist Control Group
n=38 Participants
Wait-list control group
|
iSOFIE
n=38 Participants
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)
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.85 years
STANDARD_DEVIATION 7.83 • n=5 Participants
|
30.57 years
STANDARD_DEVIATION 7.96 • n=7 Participants
|
28.82 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
38 participants
n=5 Participants
|
38 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Waitlist Control Group
n=38 Participants
Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
|
iSOFIE
n=38 Participants
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)
|
|---|---|---|
|
Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)
Pre-intervention assessment
|
78.60 units on a scale
Standard Deviation 16.14
|
78.47 units on a scale
Standard Deviation 21.78
|
|
Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)
Post-intervention assessment
|
73.69 units on a scale
Standard Deviation 26.46
|
43.98 units on a scale
Standard Deviation 23.17
|
|
Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)
Six month follow up
|
NA units on a scale
Standard Deviation NA
Follow-up data on the waitlist control participants were not collected as this group received an active intervention starting from week 10.
|
35.77 units on a scale
Standard Deviation 25.44
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Waitlist Control Group
n=38 Participants
Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
|
iSOFIE
n=38 Participants
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)
|
|---|---|---|
|
Social Phobia Inventory (SPIN)
Pre-intervention assessment
|
45.50 units on a scale
Standard Deviation 9.45
|
45.15 units on a scale
Standard Deviation 9.69
|
|
Social Phobia Inventory (SPIN)
Post-intervention assessment
|
43.22 units on a scale
Standard Deviation 10.94
|
27.95 units on a scale
Standard Deviation 13.04
|
|
Social Phobia Inventory (SPIN)
Six month follow up
|
NA units on a scale
Standard Deviation NA
Follow-up data on the waitlist control participants were not collected as this group received an active intervention starting from week 10.
|
19.74 units on a scale
Standard Deviation 13.00
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Waitlist Control Group
n=38 Participants
Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
|
iSOFIE
n=38 Participants
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)
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Pre-intervention assessment
|
15.39 units on a scale
Standard Deviation 6.99
|
15.15 units on a scale
Standard Deviation 7.47
|
|
Beck Depression Inventory-II (BDI-II)
Post-intervention assessment
|
12.77 units on a scale
Standard Deviation 7.27
|
7.25 units on a scale
Standard Deviation 5.95
|
|
Beck Depression Inventory-II (BDI-II)
Six month follow up
|
NA units on a scale
Standard Deviation NA
Follow-up data on the waitlist control participants were not collected as this group received an active intervention starting from week 10.
|
6.44 units on a scale
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Waitlist Control Group
n=38 Participants
Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
|
iSOFIE
n=38 Participants
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)
|
|---|---|---|
|
Attitude and Belief Scale-II (ABS-II)
Pre-intervention assessment
|
124.60 units on a scale
Standard Deviation 41.50
|
120.94 units on a scale
Standard Deviation 39.78
|
|
Attitude and Belief Scale-II (ABS-II)
Post-intervention assessment
|
102.51 units on a scale
Standard Deviation 46.62
|
76.62 units on a scale
Standard Deviation 34.81
|
|
Attitude and Belief Scale-II (ABS-II)
Six month follow up
|
NA units on a scale
Standard Deviation NA
Follow-up data on the wait-list control participants were not collected as this group received an active intervention starting from week 10.
|
57.96 units on a scale
Standard Deviation 31.67
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Waitlist Control Group
n=38 Participants
Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
|
iSOFIE
n=38 Participants
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)
|
|---|---|---|
|
Anxiety Sensitivity Index (ASI)
Pre-intervention assessment
|
29.00 units on a scale
Standard Deviation 9.58
|
29.28 units on a scale
Standard Deviation 11.40
|
|
Anxiety Sensitivity Index (ASI)
Post-intervention assessment
|
26.17 units on a scale
Standard Deviation 10.26
|
18.38 units on a scale
Standard Deviation 10.34
|
|
Anxiety Sensitivity Index (ASI)
Six month follow up
|
NA units on a scale
Standard Deviation NA
Follow-up data on the wait-list control participants were not collected as this group received an active intervention starting from week 10.
|
13.40 units on a scale
Standard Deviation 9.40
|
Adverse Events
Waitlist Control Group
iSOFIE
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Waitlist Control Group
n=38 participants at risk
Wait-list control group
|
iSOFIE
n=38 participants at risk
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)
|
|---|---|---|
|
Psychiatric disorders
Social Anxiety
|
100.0%
38/38 • Number of events 38
|
100.0%
38/38 • Number of events 38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place