Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

Social Phobia Clinical Trial

— SOFIE13a  

Official title:

Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570400
• Other study ID #: SOFIE13a
• Status: Completed
• Phase: N/A
• First received: March 29, 2012
• Last updated: October 29, 2016
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces symptoms of social phobia among a population diagnosed with this disorder.

Description:

Previous studies have shown that individuals with social phobia have attention biases, often focusing on or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent provided

• Diagnosed social phobia (according to DSM-IV criteria)

• Access to computer with internet connection

Exclusion Criteria:

• Severe depression (and/or suicidal behavior)

• Suffer from other severe psychiatric condition (e.g. psychosis)

• Non-stable use of medication (3 months stable dosage)

• Undergoing other, parallel psychological treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Internet-administered cognitive behavioral therapy (iCBT)
Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.
• Cognitive bias modification training program variant 1
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face. Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.
• Cognitive bias modification training program variant 2
Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency. Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks.

Locations

Country	Name	City	State
Sweden	Department of Psychology, Umeå University	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Boettcher J, Andersson G, Carlbring P; SOFIE-13 Research Group. Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial. Trials. 2013 Mar 8;14:68. doi: 10.1186/1745-6215-14-68. — View Citation

Boettcher J, Hasselrot J, Sund E, Andersson G, Carlbring P. Combining attention training with internet-based cognitive-behavioural self-help for social anxiety: a randomised controlled trial. Cogn Behav Ther. 2014;43(1):34-48. doi: 10.1080/16506073.2013.8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	24 hours	No
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	11 weeks	No
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	4 months	No
Primary	Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)	The Liebowitz Social Anxiety Scale (LSAS) is a questionnaire by psychiatrist and researcher, Michael Liebowitz, whose objective is to assess the range of social interaction and performance situations which patients with social anxiety disorder may fear. It is commonly used to study outcomes in clinical trials. The scale features 24 items, 13 relating to performance anxiety and 11 concerning social situations. It is not intended for use as a self-reporting diagnosis.	Two weeks into treatment	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	24 hours	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	11 weeks	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	4 months	No
Secondary	Change from baseline in Quality Of Life Inventory (QOLI)	The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.	2 weeks into treatment	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	24 hours	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	11 weeks	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	4 months	No
Secondary	Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale	Self-rated measurements of social anxiety/phobia.	2 weeks into treatment	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	24 hours	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	11 weeks	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	4 months	No
Secondary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	2 weeks into treatment	No
Secondary	Change from baseline in mini-SPIN	Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.	Daily, 1-15 days into treatment	No
Secondary	Change from baseline in mini-SPIN	Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.	11 weeks	No
Secondary	Change from baseline in mini-SPIN	Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.	4 months	No