Social PhobiaSOFIE-11NCT01463137
Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
A study testing Attention bias modification in people with Social Phobia, run by Umeå University at 1 site in Sweden.
Trial summary
A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Attention bias modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Jan 2013
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
- Comorbidity is allowed, but social phobia must be the primary diagnosis.
Who cannot join
- Below 18 years old.
- Individuals who are suicide prone will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychology, Umeå University
Umeå, Västerbotten County, 901 87
About this study
Official title: Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.
Read the detailed description
Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.
- Conditions
- Social Phobia
- Being tested
- Attention bias modification
- Keywords
- social phobia, anxiety
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention bias modificationBehavioural
All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Control training with words | Sham comparator | Computerized, internet-based control training program. Participant is exposed to a pair of words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word 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 word and the more negative word with equal frequency. Receives: Behavioral: Attention bias modification |
| Control training with words + pictures | Sham comparator | Computerized, internet-based control training program. 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. Receives: Behavioral: Attention bias modification |
| Positive bias training with words | Active comparator | Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word. Receives: Behavioral: Attention bias modification |
| Positive bias training with words + pictures | Active comparator | Computerized, internet-based training program for implicit modification of cognitive bias of attention, 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 always follows the more positive word or face. Receives: Behavioral: Attention bias modification |
| Negative bias training with words | Active comparator | Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word 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. Receives: Behavioral: Attention bias modification |
| Negative bias training with words + pictures | Active comparator | 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. Receives: Behavioral: Attention bias modification |
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 version
Change from baseline in social anxiety symptoms expected between time frames.
Measured: pretreatment (week 0), post treatment (week 2), 4 month follow-up
Secondary outcomes (5)
Change from baseline in Social Phobia Screening Questionnaire
Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia.
Change from baseline in social anxiety symptoms expected between time frames.
Measured: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Social Interaction Anxiety Scale (SIAS)
Change from baseline in social anxiety symptoms expected between time frames.
Measured: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Social Phobia Scale (SPS)
Change from baseline in social anxiety symptoms expected between time frames.
Measured: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)
Measure depression.
Change from baseline in depressive symptoms expected between time frames.
Measured: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Quality of Life Inventory (QOLI)
Measure quality of life.
Change from baseline in quality of life expected between time frames.
Measured: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, PhD, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463137
- Sponsor's protocol ID
- SOFIE-11
- Acronym
- SOFIE-11
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2011
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boettcher J, Leek L, Matson L, Holmes EA, Browning M, MacLeod C, Andersson G, Carlbring P. Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues. PLoS One. 2013 Sep 30;8(9):e71760. doi: 10.1371/journal.pone.0071760. eCollection 2013.
PubMed 24098630
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
- Computerized Attention Bias Modification Training in Social Phobia/Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01463137
- Acronym / sponsor ID
- SOFIE-11 / SOFIE-11
- Conditions
- Social Phobia
- Keywords
- social phobia, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Nov 2011 (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.
A study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.
Detailed description
Previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. Computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. In this study, such a program will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of Social Anxiety Disorder. Participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control training with words | Sham comparator | Behavioral: Attention bias modificationComputerized, internet-based control training program. Participant is exposed to a pair of words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word 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 word and the more negative word with equal frequency. |
| Control training with words + pictures | Sham comparator | Behavioral: Attention bias modificationComputerized, internet-based control training program. 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. |
| Positive bias training with words | Active comparator | Behavioral: Attention bias modificationComputerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word. |
| Positive bias training with words + pictures | Active comparator | Behavioral: Attention bias modificationComputerized, internet-based training program for implicit modification of cognitive bias of attention, 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 always follows the more positive word or face. |
| Negative bias training with words | Active comparator | Behavioral: Attention bias modificationComputerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- 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 and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word 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. |
| Negative bias training with words + pictures | Active comparator | Behavioral: Attention bias modificationComputerized, 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
- Comorbidity is allowed, but social phobia must be the primary diagnosis.
Key exclusion criteria (2 listed)
- Below 18 years old.
- Individuals who are suicide prone will be excluded from the study.
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 |
|---|---|---|
| Attention bias modificationAll arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days. | Behavioural | Control training with words, Control training with words + pictures, Negative bias training with words, Negative bias training with words + pictures, Positive bias training with words, Positive bias training with words + pictures |
Primary outcome
Change from baseline in Liebowitz Social Anxiety Scale self rated version
Time frame: pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in social anxiety symptoms expected between time frames.
5 secondary outcomes
Change from baseline in Social Phobia Screening Questionnaire
Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Social Interaction Anxiety Scale (SIAS)
Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Social Phobia Scale (SPS)
Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS-S)
Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
Change from baseline in Quality of Life Inventory (QOLI)
Time frame: Pretreatment (week 0), post treatment (week 2), 4 month follow-up
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.
- Results publication: PubMed 24098630Boettcher J, Leek L, Matson L, Holmes EA, Browning M, MacLeod C, Andersson G, Carlbring P. Internet-based attention bias modification for social anxiety: a randomised controlled comparison of training towards negative and training towards positive cues. PLoS One. 2013 Sep 30;8(9):e71760. doi: 10.1371/journal.pone.0071760. eCollection 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention bias modification 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 2 inclusion and 2 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. Some participants in this study may receive a placebo. 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 version (time frame: pretreatment (week 0), post treatment (week 2), 4 month follow-up). 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 NCT01463137, which also lists 1 linked publication.
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.