Social Anxiety DisorderSTePSNCT05015166
Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder
A study testing Experimental: Internet delivered self-help program with therapist support and Internet delivered self-help program without therapist support in people with Social Anxiety Disorder, run by Stockholm University at 1 site in Sweden.
Trial summary
The aim of this randomized, controlled study is to examine an internet delivered, self-help program for social anxiety based on psychodynamic therapy. The study will compare three conditions: the psychodynamic program with therapist support, without therapist support and a waitlist control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Experimental: Internet delivered self-help program with therapist support and Internet delivered self-help program without therapist support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteSweden
- Study dates
- 18 Aug 2021to 12 Jan 2023
- 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
- 18 years old or older
- Fulfill the DSM-5 criteria for social anxiety disorder (Score > 60 on the self-assessment instrument LSAS-SR)
- Have access to a computer/smartphone/tablet with internet connection
- Be able to read and write Swedish.
Who cannot join
- Suicidal (within the previous month, assessed with the self-assessment instrument C-SSRS)
- Partaking in psychological treatment
- Ongoing treatment with psychopharmacological drugs with dose adjustments within the nearest month or planned dose adjustments.
- The following self-reported diagnoses are excluded:
- Autism spectrum disorder
- Serious depression (Score ≥ 20 on the PHQ9)
- Indications of psychosis or bipolar disorder (type 1 or 2).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this randomized, controlled study is to examine an internet delivered, self-help program for social anxiety based on psychodynamic therapy. The study will compare three conditions: the psychodynamic program with therapist support, without therapist support and a waitlist control.
- Conditions
- Social Anxiety Disorder
- Being tested
- Experimental: Internet delivered self-help program with therapist support, Internet delivered self-help program without therapist support
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Internet delivered self-help program with therapist supportBehavioural
During 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises which a therapist gives feedback on.
Internet delivered self-help program without therapist supportBehavioural
During 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises.
| Study group | Role | What they receive |
|---|---|---|
| Internet delivered self-help program with therapist support | Experimental | The intervention consists of 8 therapist-supported self-help modules delivered over 8 weeks on a secure online platform. Modules consist of texts and video followed by exercises which they send to their therapist and receive feedback within a few days.
The treatment is based on principles from affect-focused psychodynamic psychotherapy. Receives: Behavioral: Experimental: Internet delivered self-help program with therapist support |
| Internet delivered self-help program without therapist support | Active comparator | The intervention consists of 8 self-help modules delivered over 8 weeks on a secure online platform. Modules consist of texts and video followed by exercises which the participants are encouraged to try. The treatment is based on principles from affect-focused psychodynamic psychotherapy. Receives: Behavioral: Internet delivered self-help program without therapist support |
| Waitlist | No intervention | Participants will receive no intervention for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale, Self-Report, (LSAS-SR)
The LSAS-SR features 48 items assessing social anxiety symptoms.
Measured: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Secondary outcomes (3)
Generalised Anxiety Disorder 7- item scale (GAD-7)
The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder.
Measured: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Patient Health Questionnaire 9-item scale (PHQ-9)
The PHQ-9 features nine items for assessing depression in a clinical context and screening of depression in the general population
Measured: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Brunnsviken Brief Quality of Life Scale (BBQ)
The BBQ features 12 items concerning 6 areas of life rated on importance and satisfaction.
Measured: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start18 Aug 2021
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
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.
- 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
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, Stockholm University
- Investigators
- Per Carlbring, PhD, Principal investigator, Department of Psychology at Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015166
- Sponsor's protocol ID
- STePS
- Acronym
- STePS
- Status last verified
- Jan 2023
- First submitted
- 9 Aug 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Parts will be shared in an open data repository.
Publications
Mechler J, Lindqvist K, Magnusson K, Ringstrom A, Krafman JD, Alvinzi P, Kassius L, Sowa J, Andersson G, Carlbring P. Guided and unguided internet-delivered psychodynamic therapy for social anxiety disorder: A randomized controlled trial. Npj Ment Health Res. 2024 May 10;3(1):21. doi: 10.1038/s44184-024-00063-0.
PubMed 38730030
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05015166
- Acronym / sponsor ID
- STePS / STePS
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 20 Aug 2021 (actual)
- 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 aim of this randomized, controlled study is to examine an internet delivered, self-help program for social anxiety based on psychodynamic therapy. The study will compare three conditions: the psychodynamic program with therapist support, without therapist support and a waitlist control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet delivered self-help program with therapist support | Experimental | Behavioral: Experimental: Internet delivered self-help program with therapist supportThe intervention consists of 8 therapist-supported self-help modules delivered over 8 weeks on a secure online platform. Modules consist of texts and video followed by exercises which they send to their therapist and receive feedback within a few days. The treatment is based on principles from affect-focused psychodynamic psychotherapy. |
| Internet delivered self-help program without therapist support | Active comparator | Behavioral: Internet delivered self-help program without therapist supportThe intervention consists of 8 self-help modules delivered over 8 weeks on a secure online platform. Modules consist of texts and video followed by exercises which the participants are encouraged to try. The treatment is based on principles from affect-focused psychodynamic psychotherapy. |
| Waitlist | No intervention | –Participants will receive no intervention for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Fulfill the DSM-5 criteria for social anxiety disorder (Score > 60 on the self-assessment instrument LSAS-SR)
- Have access to a computer/smartphone/tablet with internet connection
- Be able to read and write Swedish.
Key exclusion criteria (7 listed)
- Suicidal (within the previous month, assessed with the self-assessment instrument C-SSRS)
- Partaking in psychological treatment
- Ongoing treatment with psychopharmacological drugs with dose adjustments within the nearest month or planned dose adjustments.
- Autism spectrum disorder
- Serious depression (Score ≥ 20 on the PHQ9)
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 |
|---|---|---|
| Experimental: Internet delivered self-help program with therapist supportDuring 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises which a therapist gives feedback on. | Behavioural | Internet delivered self-help program with therapist support |
| Internet delivered self-help program without therapist supportDuring 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises. | Behavioural | Internet delivered self-help program without therapist support |
Primary outcome
Liebowitz Social Anxiety Scale, Self-Report, (LSAS-SR)
Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
The LSAS-SR features 48 items assessing social anxiety symptoms.
3 secondary outcomes
Generalised Anxiety Disorder 7- item scale (GAD-7)
Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Patient Health Questionnaire 9-item scale (PHQ-9)
Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)
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 13 Jan 2023.
- Derived from this study: PubMed 38730030Mechler J, Lindqvist K, Magnusson K, Ringstrom A, Krafman JD, Alvinzi P, Kassius L, Sowa J, Andersson G, Carlbring P. Guided and unguided internet-delivered psychodynamic therapy for social anxiety disorder: A randomized controlled trial. Npj Ment Health Res. 2024 May 10;3(1):21. doi: 10.1038/s44184-024-00063-0.
- Individual participant dataSharing planned: Undecided. Parts will be shared in an open data repository.
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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, PhD principal investigator
Department of Psychology at Stockholm 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 Experimental: Internet delivered self-help program with therapist support and Internet delivered self-help program without therapist support in people with Social Anxiety Disorder, run by Stockholm 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 4 inclusion and 7 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 13 Jan 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, Self-Report, (LSAS-SR) (time frame: Change from baseline to post-treatment (8 week) and follow up (6, 12 and 24 months after treatment)). 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 NCT05015166, 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 13 Jan 2023.