Social PhobiaSOFIE13aNCT01570400
Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT
A study testing Internet-administered cognitive behavioral therapy (iCBT), Cognitive bias modification training program variant 1 and Cognitive bias modification training program variant 2 in people with Social Phobia, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Phobia
- What is being tested?
- Internet-administered cognitive behavioral therapy (iCBT), Cognitive bias modification training program variant 1 and Cognitive bias modification training program variant 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent provided
- Diagnosed social phobia (according to DSM-IV criteria)
- Access to computer with internet connection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychology, Umeå University
Umeå, Västerbotten County, 90187
About this study
Official title: Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
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.
Read the 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).
- Conditions
- Social Phobia
- Being tested
- Internet-administered cognitive behavioral therapy (iCBT), Cognitive bias modification training program variant 1, Cognitive bias modification training program variant 2
- Keywords
- social phobia, social anxiety, cognitive bias modification
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-administered cognitive behavioral therapy (iCBT)Behavioural
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 1Behavioural
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 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBM training program variant 1 + iCBT | Experimental | Cognitive bias modification training program variant 1 combined with iCBT Receives: Behavioral: Internet-administered cognitive behavioral therapy (iCBT); Behavioral: Cognitive bias modification training program variant 1 |
| CBM training program variant 2 + iCBT | Experimental | Cognitive bias modification training program variant 2 combined with iCBT Receives: Behavioral: Internet-administered cognitive behavioral therapy (iCBT); Behavioral: Cognitive bias modification training program variant 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
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.
Measured: 11 weeks
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.
Measured: 4 months
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.
Measured: Two weeks into treatment
Secondary outcomes (15)
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.
Measured: 24 hours
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.
Measured: 11 weeks
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.
Measured: 4 months
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.
Measured: 2 weeks into treatment
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Measured: 24 hours
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Measured: 11 weeks
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Measured: 4 months
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
Measured: 2 weeks into treatment
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 11 weeks
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 4 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 2 weeks into treatment
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.
Measured: Daily, 1-15 days into treatment
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.
Measured: 11 weeks
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, PhD, Umeå University
- Investigators
- Per Carlbring, Professor, Principal investigator, Department of Psychology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570400
- Sponsor's protocol ID
- SOFIE13a
- Acronym
- SOFIE13a
- Status last verified
- Oct 2016
- First submitted
- 29 Mar 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23497513Boettcher 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.
PubMed 23898817
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Social Phobia Symptoms With Combined Internet-Based Cognitive Bias Modification and Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT01570400
- Acronym / sponsor ID
- SOFIE13a / SOFIE13a
- Conditions
- Social Phobia
- Keywords
- social phobia, social anxiety, cognitive bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBM training program variant 1 + iCBT | Experimental | Behavioral: Internet-administered cognitive behavioral therapy (iCBT), Behavioral: Cognitive bias modification training program variant 1Cognitive bias modification training program variant 1 combined with iCBT |
| CBM training program variant 2 + iCBT | Experimental | Behavioral: Internet-administered cognitive behavioral therapy (iCBT), Behavioral: Cognitive bias modification training program variant 2Cognitive bias modification training program variant 2 combined with iCBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent provided
- Diagnosed social phobia (according to DSM-IV criteria)
- Access to computer with internet connection
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBM training program variant 1 + iCBT, CBM training program variant 2 + iCBT |
| Cognitive bias modification training program variant 1Computerized, 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. | Behavioural | CBM training program variant 1 + iCBT |
| Cognitive bias modification training program variant 2Computerized, 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. | Behavioural | CBM training program variant 2 + iCBT |
Primary outcome
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR)
Time frame: 24 hours
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)
Time frame: 11 weeks
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)
Time frame: 4 months
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)
Time frame: Two weeks into treatment
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.
15 secondary outcomes
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 11 weeks
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 4 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 2 weeks into treatment
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time frame: 24 hours
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time frame: 11 weeks
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time frame: 4 months
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Time frame: 2 weeks into treatment
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 11 weeks
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 4 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 2 weeks into treatment
Change from baseline in mini-SPIN
Time frame: Daily, 1-15 days into treatment
Change from baseline in mini-SPIN
Time frame: 11 weeks
Change from baseline in mini-SPIN
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Background: PubMed 23497513Boettcher 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 publication: PubMed 23898817Boettcher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Carlbring, Professor principal investigator
Department of Psychology, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-administered cognitive behavioral therapy (iCBT), Cognitive bias modification training program variant 1 and Cognitive bias modification training program variant 2 in people with Social Phobia, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Liebowitz Social Anxiety Scale Self-Rated (LSAS-SR) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.