Internet Treatment for Social Phobia in Romania

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01557894

Acronym

iSOFIE-Ro

Enrollment

Registered

2012-03-20

Start date

2012-04-30

Completion date

2013-03-31

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phobia, Social

Keywords

Social anxiety disorders, Social phobia, Anxiety sensitivity, Irrational thinking, Guided self-help, Internet-delivered treatment

Brief 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. 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.

Interventions

OTHERiSOFIE

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)	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)	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

Measure	Time frame	Description
Beck Depression Inventory-II (BDI-II)	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.
Attitude and Belief Scale-II (ABS-II)	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.
Anxiety Sensitivity Index (ASI)	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.

Countries

Romania

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Waitlist Control Group Wait-list control group	38
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)	38
Total	76

Baseline characteristics

Characteristic	iSOFIE	Waitlist Control Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	38 Participants	38 Participants	76 Participants
Age, Continuous	30.57 years STANDARD_DEVIATION 7.96	27.85 years STANDARD_DEVIATION 7.83	28.82 years STANDARD_DEVIATION 8.04
Region of Enrollment Romania	38 participants	38 participants	76 participants
Sex: Female, Male Female	22 Participants	23 Participants	45 Participants
Sex: Female, Male Male	16 Participants	15 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	38 / 38	38 / 38
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

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