Social Anxiety DisorderSOFIANCT02105259
Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder (SOFIA)
A study testing Psychodynamic Internet Treatment and Waiting list in people with Social Anxiety Disorder, run by Linkoeping University at 1 site in Sweden.
Trial summary
The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Psychodynamic Internet Treatment and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to May 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social anxiety disorder as diagnosed by the MINI diagnostic interview
Who cannot join
- Severe depression
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Behavioural Sciences and Learning, Linköping University
Linköping, 58183
About this study
Official title: Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder: A Randomized Controlled Trial
The overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.
Read the detailed description
Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.
- Conditions
- Social Anxiety Disorder
- Being tested
- Psychodynamic Internet Treatment, Waiting list
- Keywords
- Test, psychodynamic, Internet-delivered psychodynamic treatment, patients with social anxiety disorder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodynamic Internet TreatmentBehavioural
Psychodynamic Internet Treatment for patients social anxiety disorder
Waiting listOther
Waiting list, where participants wait for delayed treatment
| Study group | Role | What they receive |
|---|---|---|
| Psychodynamic Internet Treatment | Experimental | Psychodynamic Internet Treatment for social anxiety disorder during 10 weeks and guided by a psychologist Receives: Behavioral: Psychodynamic Internet Treatment |
| Waiting list with support | Active comparator | Behavioral: supportive check-ups via the Internet during 10 weeks Receives: Other: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale
Measured: Baseline and End of treatment (10 weeks)
Secondary outcomes (4)
Patient Health Questionnaire Depression 9 item
Measured: Baseline
Patient Health Questionnaire Depression 9 item
Measured: End of treatment (10 weeks)
Patient Health Questionnaire Anxiety 7 item
Measured: Baseline
Patient Health Questionnaire Anxiety 7 item
Measured: End of treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
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 Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Linkoeping 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Stockholm University
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105259
- Sponsor's protocol ID
- GA-ANX2014-APT
- Acronym
- SOFIA
- Status last verified
- Aug 2015
- First submitted
- 2 Apr 2014
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansson R, Hesslow T, Ljotsson B, Jansson A, Jonsson L, Fardig S, Karlsson J, Hesser H, Frederick RJ, Lilliengren P, Carlbring P, Andersson G. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. Psychotherapy (Chic). 2017 Dec;54(4):351-360. doi: 10.1037/pst0000147.
PubMed 29251954
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Psychodynamic Therapy for Social Anxiety Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02105259
- Acronym / sponsor ID
- SOFIA / GA-ANX2014-APT
- Conditions
- Social Anxiety Disorder
- Keywords
- Test, psychodynamic, Internet-delivered psychodynamic treatment, patients with social anxiety disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Karolinska Institutet, Stockholm University
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Apr 2014 (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 overall aim of this study is to develop and test a psychodynamic Internet--delivered psychological treatment for patients with social anxiety disorder and compare its efficacy to a waiting list.
Detailed description
Participants with social anxiety disorder (MINI telephone interview) will be recruited via mass media and randomly allocated to psychodynamic Internet--delivered psychological treatment or to a waiting list control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychodynamic Internet Treatment | Experimental | Behavioral: Psychodynamic Internet TreatmentPsychodynamic Internet Treatment for social anxiety disorder during 10 weeks and guided by a psychologist |
| Waiting list with support | Active comparator | Other: Waiting listBehavioral: supportive check-ups via the Internet during 10 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Social anxiety disorder as diagnosed by the MINI diagnostic interview
Key exclusion criteria (1 listed)
- Severe depression
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 |
|---|---|---|
| Psychodynamic Internet TreatmentPsychodynamic Internet Treatment for patients social anxiety disorder | Behavioural | Psychodynamic Internet Treatment |
| Waiting listWaiting list, where participants wait for delayed treatment | Other | Waiting list with support |
Primary outcome
Liebowitz Social Anxiety Scale
Time frame: Baseline and End of treatment (10 weeks)
4 secondary outcomes
Patient Health Questionnaire Depression 9 item
Time frame: Baseline
Patient Health Questionnaire Depression 9 item
Time frame: End of treatment (10 weeks)
Patient Health Questionnaire Anxiety 7 item
Time frame: Baseline
Patient Health Questionnaire Anxiety 7 item
Time frame: End of treatment (10 weeks)
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 5 Oct 2023.
- Derived from this study: PubMed 29251954Johansson R, Hesslow T, Ljotsson B, Jansson A, Jonsson L, Fardig S, Karlsson J, Hesser H, Frederick RJ, Lilliengren P, Carlbring P, Andersson G. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. Psychotherapy (Chic). 2017 Dec;54(4):351-360. doi: 10.1037/pst0000147.
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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.
Gerhard Andersson principal investigator
Linkoeping 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 Psychodynamic Internet Treatment and Waiting list in people with Social Anxiety Disorder, run by Linkoeping 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 1 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 5 Oct 2023. 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?
Liebowitz Social Anxiety Scale (time frame: Baseline and End of treatment (10 weeks)). 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 NCT02105259, 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 5 Oct 2023.