Social PhobiaSOFIE-8NCT01312571
Treatment of Social Phobia Over the Internet
A study testing Internet-based cognitive behavioural therapy (iCBT) and Internet-based computerized attention training in people with Social Phobia, run by Umeå University at 1 site in Sweden.
Trial summary
Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). 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-based cognitive behavioural therapy (iCBT) and Internet-based computerized attention training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to Feb 2016
- 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
- Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
Who cannot join
- Individuals with current depression and/or is suicide prone will be excluded from the study.
- With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.
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: Functional Magnetic Resonance Imaging (fMRI) and Treatment of Social Phobia Over the Internet: Cognitive Behavioural Therapy (CBT) Versus Computerized Attention Training and the Possible Effect of Genetic Variation. (SOFIE-8)
Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample.
Study hypothesis
Read more
How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes?
How is the genetic variations related to symptoms in social phobia (pre treatment)?
- Conditions
- Social Phobia
- Being tested
- Internet-based cognitive behavioural therapy (iCBT), Internet-based computerized attention training
- 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-based cognitive behavioural therapy (iCBT)Behavioural
The Internet-based cognitive behavioural therapy (iCBT) consists of our structured self-help program lasting a total of nine active treatment weeks. This treatment program has been well evaluated and involved in several research projects.
Internet-based computerized attention trainingBehavioural
The Internet-based computerized attention training program lasting a total of four active treatment weeks. The treatment is consist of two training sessions per week, about 10 minutes long.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavior therapy via the internet | Active comparator | Cognitive behavior therapy via the internet with therapist support. Receives: Behavioral: Internet-based cognitive behavioural therapy (iCBT) |
| Attentional retraining | Active comparator | Attentional retraining as described by Nader Amir. Receives: Behavioral: Internet-based computerized attention training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in recruited brain regions measured using regional cerebral blood flow
Blood-oxygen-level dependence (BOLD) signal change as measured with 3.0 T fMRI
Change from baseline in BOLD signal expected between time frames.
Measured: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Social Phobia Screening Questionnaire (SPSQ)
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 11), 1 yr follow-up (week 63)
Liebowitz Social Anxiety Scale self rated version (LSAS-SR)
Measure social anxiety and social phobia.
Change from baseline in social anxiety symptoms expected between time frames.
Measured: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Social Interaction Anxiety Scale (SIAS)
Measure social anxiety and social phobia.
Change from baseline in social anxiety symptoms expected between time frames.
Measured: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Social Phobia Scale (SPS)
Measure social phobia.
Change from baseline in social anxiety symptoms expected between time frames.
Measured: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Secondary outcomes (4)
Variation in genes that have been associated with emotional processing
We will study allelic variation in genes that have been associated with emotional processing e.g. monoaminergic gene polymorphisms such as the serotonin-transporter-linked promoter region (5-HTTLPR), tryptophan hydroxylase-2 (TPH2) G-703T, and Catechol-O-methyltransferase (COMT) 158Val/Met polymorphism
Measured: pretreatment (week 0).
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 11), 1 yr follow-up (week 63)
Beck Anxiety Inventory (BAI)
Measure anxiety.
Change from baseline in anxiety symptoms expected between time frames.
Measured: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
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 11), 1 yr follow-up (week 63)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Per Carlbring, PhD, Umeå University
- Investigators
- Per Carlbring, Professor, Study director, Umeå UniversityGerhard Andersson, Professor, Study chair, Linkoeping UniversityTomas Furmark, Ass. professor, Study chair, Uppsala UniversityCarl-Johan Olsson, Post doc, Study chair, Umeå center for Functional Brain ImagingOwe Bodlund, Ass. professor, Study chair, NUSKristoffer NT Månsson, Student, Study chair, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312571
- Sponsor's protocol ID
- 2010-185-31 M
- Acronym
- SOFIE-8
- Status last verified
- Oct 2016
- First submitted
- 31 Aug 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mansson KN, Frick A, Boraxbekk CJ, Marquand AF, Williams SC, Carlbring P, Andersson G, Furmark T. Predicting long-term outcome of Internet-delivered cognitive behavior therapy for social anxiety disorder using fMRI and support vector machine learning. Transl Psychiatry. 2015 Mar 17;5(3):e530. doi: 10.1038/tp.2015.22.
PubMed 25781229Mansson KN, Salami A, Frick A, Carlbring P, Andersson G, Furmark T, Boraxbekk CJ. Neuroplasticity in response to cognitive behavior therapy for social anxiety disorder. Transl Psychiatry. 2016 Feb 2;6(2):e727. doi: 10.1038/tp.2015.218.
PubMed 26836415Mansson KN, Carlbring P, Frick A, Engman J, Olsson CJ, Bodlund O, Furmark T, Andersson G. Altered neural correlates of affective processing after internet-delivered cognitive behavior therapy for social anxiety disorder. Psychiatry Res. 2013 Dec 30;214(3):229-37. doi: 10.1016/j.pscychresns.2013.08.012. Epub 2013 Sep 21.
PubMed 24064198
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
- Functional Magnetic Resonance Imaging (fMRI) and Treatment of Social Phobia Over the Internet: Cognitive Behavioural Therapy (CBT) Versus Computerized Attention Training and the Possible Effect of Genetic Variation. (SOFIE-8)
- ClinicalTrials.gov ID
- NCT01312571
- Acronym / sponsor ID
- SOFIE-8 / 2010-185-31 M
- Conditions
- Social Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Aug 2010
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Mar 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.
Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample.
Study hypothesis
How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes?
How is the genetic variations related to symptoms in social phobia (pre treatment)?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavior therapy via the internet | Active comparator | Behavioral: Internet-based cognitive behavioural therapy (iCBT)Cognitive behavior therapy via the internet with therapist support. |
| Attentional retraining | Active comparator | Behavioral: Internet-based computerized attention trainingAttentional retraining as described by Nader Amir. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must meet criteria for social phobia using the International classification system Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
Key exclusion criteria (2 listed)
- Individuals with current depression and/or is suicide prone will be excluded from the study.
- With fMRI the following criteria must not be filled: previous surgery in the heart or brain, metals implanted in the body, dental braces or bridge; piercings that can´t be taken out, tattoos (shoulders, arms and back is not so good, the legs are okay if it is not too large); trouble to lie still for about an hour, pregnancy or history of neurological diseases.
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-based cognitive behavioural therapy (iCBT)The Internet-based cognitive behavioural therapy (iCBT) consists of our structured self-help program lasting a total of nine active treatment weeks. This treatment program has been well evaluated and involved in several research projects. | Behavioural | Cognitive behavior therapy via the internet |
| Internet-based computerized attention trainingThe Internet-based computerized attention training program lasting a total of four active treatment weeks. The treatment is consist of two training sessions per week, about 10 minutes long. | Behavioural | Attentional retraining |
Primary outcome
Differences in recruited brain regions measured using regional cerebral blood flow
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Blood-oxygen-level dependence (BOLD) signal change as measured with 3.0 T fMRI Change from baseline in BOLD signal expected between time frames.
Social Phobia Screening Questionnaire (SPSQ)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Social Phobia Screening Questionnaire (SPSQ), diagnostic tool for social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Liebowitz Social Anxiety Scale self rated version (LSAS-SR)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Social Interaction Anxiety Scale (SIAS)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Measure social anxiety and social phobia. Change from baseline in social anxiety symptoms expected between time frames.
Social Phobia Scale (SPS)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Measure social phobia. Change from baseline in social anxiety symptoms expected between time frames.
4 secondary outcomes
Variation in genes that have been associated with emotional processing
Time frame: pretreatment (week 0).
Montgomery Åsberg Depression Rating Scale (MADRS-S)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Beck Anxiety Inventory (BAI)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
Quality of Life Inventory (QOLI)
Time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)
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 25781229Mansson KN, Frick A, Boraxbekk CJ, Marquand AF, Williams SC, Carlbring P, Andersson G, Furmark T. Predicting long-term outcome of Internet-delivered cognitive behavior therapy for social anxiety disorder using fMRI and support vector machine learning. Transl Psychiatry. 2015 Mar 17;5(3):e530. doi: 10.1038/tp.2015.22.
- Results publication: PubMed 26836415Mansson KN, Salami A, Frick A, Carlbring P, Andersson G, Furmark T, Boraxbekk CJ. Neuroplasticity in response to cognitive behavior therapy for social anxiety disorder. Transl Psychiatry. 2016 Feb 2;6(2):e727. doi: 10.1038/tp.2015.218.
- Results publication: PubMed 24064198Mansson KN, Carlbring P, Frick A, Engman J, Olsson CJ, Bodlund O, Furmark T, Andersson G. Altered neural correlates of affective processing after internet-delivered cognitive behavior therapy for social anxiety disorder. Psychiatry Res. 2013 Dec 30;214(3):229-37. doi: 10.1016/j.pscychresns.2013.08.012. Epub 2013 Sep 21.
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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 study director
Umeå University
Gerhard Andersson, Professor study chair
Linkoeping University
Tomas Furmark, Ass. professor study chair
Uppsala 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-based cognitive behavioural therapy (iCBT) and Internet-based computerized attention training 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 1 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. 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?
Differences in recruited brain regions measured using regional cerebral blood flow (time frame: pretreatment (week 0), post treatment (week 11), 1 yr follow-up (week 63)). The study lists 5 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 NCT01312571, which also lists 3 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.