Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT (SOFIE13a)
Primary Purpose
Social Phobia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-administered cognitive behavioral therapy (iCBT)
Cognitive bias modification training program variant 1
Cognitive bias modification training program variant 2
Sponsored by
About this trial
This is an interventional treatment trial for Social Phobia focused on measuring social phobia, social anxiety, cognitive bias modification
Eligibility Criteria
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
Sites / Locations
- Department of Psychology, Umeå University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CBM training program variant 1 + iCBT
CBM training program variant 2 + iCBT
Arm Description
Cognitive bias modification training program variant 1 combined with iCBT
Cognitive bias modification training program variant 2 combined with iCBT
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01570400
Brief Title
Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT
Acronym
SOFIE13a
Official Title
Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia
Keywords
social phobia, social anxiety, cognitive bias modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBM training program variant 1 + iCBT
Arm Type
Experimental
Arm Description
Cognitive bias modification training program variant 1 combined with iCBT
Arm Title
CBM training program variant 2 + iCBT
Arm Type
Experimental
Arm Description
Cognitive bias modification training program variant 2 combined with iCBT
Intervention Type
Behavioral
Intervention Name(s)
Internet-administered cognitive behavioral therapy (iCBT)
Intervention Description
Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bias modification training program variant 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive bias modification training program variant 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
11 weeks
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
4 months
Title
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Description
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.
Time Frame
Two weeks into treatment
Secondary Outcome Measure Information:
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
11 weeks
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
4 months
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
2 weeks into treatment
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
24 hours
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
11 weeks
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
4 months
Title
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Description
Self-rated measurements of social anxiety/phobia.
Time Frame
2 weeks into treatment
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
24 hours
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
11 weeks
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
4 months
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
2 weeks into treatment
Title
Change from baseline in mini-SPIN
Description
Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.
Time Frame
Daily, 1-15 days into treatment
Title
Change from baseline in mini-SPIN
Description
Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.
Time Frame
11 weeks
Title
Change from baseline in mini-SPIN
Description
Mini-SPIN is a three-item self-rating scale for assessment of symptoms of social phobia using a five-point Likert scale.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Department of Psychology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90187
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23497513
Citation
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.
Results Reference
background
PubMed Identifier
23898817
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: 10.1080/16506073.2013.809141. Epub 2013 Jul 30.
Results Reference
result
Learn more about this trial
Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT
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