Social PhobiaNCT01577303
Treatment of Social Phobia With Cognitive Bias Modification
A study testing Cognitive bias modification training program variant 1, Cognitive bias modification training program variant 2 and CBM training program variant 3 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 different internet-based treatment programs, consisting of cognitive bias modification, reduce 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?
- Cognitive bias modification training program variant 1, Cognitive bias modification training program variant 2 and CBM training program variant 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2012to Oct 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 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, and printer
Who cannot join
- Severe depression (and/or suicidal behavior)
- Addiction and/or abuse
- Suffer from other severe psychiatric condition (e.g. psychosis)
- Non-stable use of medication
- 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 Internet-Based Cognitive Bias Modification
The purpose of this study is to determine whether different internet-based treatment programs, consisting of cognitive bias modification, reduce 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 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 provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.
- Conditions
- Social Phobia
- Being tested
- Cognitive bias modification training program variant 1, Cognitive bias modification training program variant 2, CBM training program variant 3, CBM training program variant 4, Control training variant 1
- 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.
Cognitive bias modification training program variant 1Behavioural
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.
Cognitive bias modification training program variant 2Behavioural
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.
CBM training program variant 3Behavioural
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.
CBM training program variant 4Behavioural
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.
Control training variant 1Behavioural
Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. 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 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.
| Study group | Role | What they receive |
|---|---|---|
| CBM training program variant 1 | Experimental | Attention training towards positive cues using words as stimuli Receives: Behavioral: Cognitive bias modification training program variant 1 |
| CBM training program variant 2 | Experimental | Attention training towards positive cues using words and faces as stimuli Receives: Behavioral: Cognitive bias modification training program variant 2 |
| CBM training program variant 3 | Experimental | Attention training towards negative using words as stimuli Receives: Behavioral: CBM training program variant 3 |
| CBM training program variant 4 | Experimental | Attention training towards negative using words and faces Receives: Behavioral: CBM training program variant 4 |
| Control training variant 1 | Experimental | Control training condition using words as stimuli Receives: Behavioral: Control training variant 1 |
| Control training variant 2 | Experimental | Control training condition using words and faces as stimuli Receives: Behavioral: Control training 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: 14 days
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
Secondary outcomes (9)
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: 14 days
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 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: 14 days
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 4 months
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: 14 days
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
Self-rated measurements of social anxiety/phobia.
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 posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionOct 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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- Investigators
- Per Carlbring, Professor, Principal investigator, Department of Psychology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577303
- Sponsor's protocol ID
- Attention training
- Status last verified
- Oct 2016
- First submitted
- 11 Apr 2012
- 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
- Reduction of Social Phobia Symptoms With Internet-Based Cognitive Bias Modification
- ClinicalTrials.gov ID
- NCT01577303
- Acronym / sponsor ID
- Attention training
- Conditions
- Social Phobia
- Keywords
- social phobia, social anxiety, cognitive bias modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 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 different internet-based treatment programs, consisting of cognitive bias modification, reduce 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 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 provided to 128 participants that meet the diagnostic criteria for social phobia. It will be compared with a program that implicitly directs the users' attention towards threatening cues. Pre/post-measurements will be compared. Participants will be randomized to one of three groups, receiving one of the two variants of the cognitive bias modification program or a control training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CBM training program variant 1 | Experimental | Behavioral: Cognitive bias modification training program variant 1Attention training towards positive cues using words as stimuli |
| CBM training program variant 2 | Experimental | Behavioral: Cognitive bias modification training program variant 2Attention training towards positive cues using words and faces as stimuli |
| CBM training program variant 3 | Experimental | Behavioral: CBM training program variant 3Attention training towards negative using words as stimuli |
| CBM training program variant 4 | Experimental | Behavioral: CBM training program variant 4Attention training towards negative using words and faces |
| Control training variant 1 | Experimental | Behavioral: Control training variant 1Control training condition using words as stimuli |
| Control training variant 2 | Experimental | Behavioral: Control training variant 2Control training condition using words and faces as stimuli |
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, and printer
Key exclusion criteria (5 listed)
- Severe depression (and/or suicidal behavior)
- Addiction and/or abuse
- Suffer from other severe psychiatric condition (e.g. psychosis)
- Non-stable use of medication
- 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 |
|---|---|---|
| Cognitive bias modification training program variant 1Computerized, 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. | Behavioural | CBM training program variant 1 |
| Cognitive bias modification training program variant 2Computerized, 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. | Behavioural | CBM training program variant 2 |
| CBM training program variant 3Computerized, 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. | Behavioural | CBM training program variant 3 |
| CBM training program variant 4Computerized, 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. | Behavioural | CBM training program variant 4 |
| Control training variant 1Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. 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.. | Behavioural | Control training variant 1 |
| Control training 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. | Behavioural | Control training variant 2 |
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: 14 days
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.
9 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: 14 days
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 4 months
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: 14 days
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 4 months
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: 14 days
Change from baseline in Social Phobia Scale + Social Interaction Anxiety Scale
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.
- 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.
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 Cognitive bias modification training program variant 1, Cognitive bias modification training program variant 2 and CBM training program variant 3 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 5 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 3 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 NCT01577303, 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; AzTrials last refreshed its copy on 7 Nov 2026.