Social PhobiaPhase 3IS1NCT00564967
A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy
A Phase 3 study testing CBT via the Internet and CBT group therapy in people with Social Phobia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Social Phobia
- What is being tested?
- CBT via the Internet and CBT group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Aug 2010
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have a primary diagnosis of social phobia
Who cannot join
- Substance abuse during the last 6 months
- Other dominating diagnosis (not phobic personality disorder)
- A history of bipolar disorder or psychosis
- Major depression according to DSM-IV and >20 on madrs-s
- Risk of suicide
- Start of medication or change of dosis during the last 2 months
- Other parallel psychological treatment
- Previous CBT (last 3 years) for social phobia
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Psykiatri Sydväst, Stockholm County Council
Stockholm, Stockholm County, 141 86
About this study
Official title: A Comparison Between Internet-based Self-help Therapy and Group Therapy for Social Phobia - A Clinical Equivalence Trial Using Cognitive Behavioural Therapy (CBT)
Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social phobia.
To the investigator´s knowledge, no study has yet directly compared live-CBT to Internet therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered via the Internet. The study is considered to be an equivalence trial. 128 patients will be randomly assigned to one of the two treatment conditions. The primary outcome measure is Liebowitz Social Anxiety Scale (LSAS).
- Conditions
- Social Phobia
- Being tested
- CBT via the Internet, CBT group therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT via the InternetBehavioural
15 weeks, patients learn about CBT primarily thru a self-help book published on teh Internet, Minimal therapy contact via e-mail(10 minutes/week),
CBT group therapyBehavioural
15 weeks, 1 session/week, (2,5 hours.)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CBT via the Internet Receives: Behavioral: CBT via the Internet |
| 2 | Experimental | 15 weeks, CBT group therapy, 1 session/week (2.5 hours). Receives: Behavioral: CBT group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale (LSAS)
Secondary outcomes (1)
SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2010
- Study completionAug 2010
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 Karolinska InstitutetThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- nils lindefors, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564967
- Sponsor's protocol ID
- IS1
- Other IDs
- Dnr 2005/178-31
- Acronym
- IS1
- Status last verified
- Aug 2009
- First submitted
- 28 Nov 2007
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersson E, Ruck C, Lavebratt C, Hedman E, Schalling M, Lindefors N, Eriksson E, Carlbring P, Andersson G, Furmark T. Genetic polymorphisms in monoamine systems and outcome of cognitive behavior therapy for social anxiety disorder. PLoS One. 2013 Nov 15;8(11):e79015. doi: 10.1371/journal.pone.0079015. eCollection 2013.
PubMed 24260145Hedman E, Andersson E, Ljotsson B, Andersson G, Andersson E, Schalling M, Lindefors N, Ruck C. Clinical and genetic outcome determinants of Internet- and group-based cognitive behavior therapy for social anxiety disorder. Acta Psychiatr Scand. 2012 Aug;126(2):126-36. doi: 10.1111/j.1600-0447.2012.01834.x. Epub 2012 Feb 9.
PubMed 22320999Hedman E, Andersson G, Ljotsson B, Andersson E, Ruck C, Mortberg E, Lindefors N. Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial. PLoS One. 2011 Mar 25;6(3):e18001. doi: 10.1371/journal.pone.0018001.
PubMed 21483704
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Internet-based Self-help Therapy and Group Therapy for Social Phobia - A Clinical Equivalence Trial Using Cognitive Behavioural Therapy (CBT)
- ClinicalTrials.gov ID
- NCT00564967
- Acronym / sponsor ID
- IS1 / IS1
- Conditions
- Social Phobia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 Nov 2007 (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.
Social phobia is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social phobia.
To the investigator´s knowledge, no study has yet directly compared live-CBT to Internet therapy. The aim of the present study is to compare the effect of live CBT vs CBT delivered via the Internet. The study is considered to be an equivalence trial. 128 patients will be randomly assigned to one of the two treatment conditions. The primary outcome measure is Liebowitz Social Anxiety Scale (LSAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: CBT via the InternetCBT via the Internet |
| 2 | Experimental | Behavioral: CBT group therapy15 weeks, CBT group therapy, 1 session/week (2.5 hours). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must have a primary diagnosis of social phobia
Key exclusion criteria (8 listed)
- Substance abuse during the last 6 months
- Other dominating diagnosis (not phobic personality disorder)
- A history of bipolar disorder or psychosis
- Major depression according to DSM-IV and >20 on madrs-s
- Risk of suicide
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 |
|---|---|---|
| CBT via the Internet15 weeks, patients learn about CBT primarily thru a self-help book published on teh Internet, Minimal therapy contact via e-mail(10 minutes/week), | Behavioural | 1 |
| CBT group therapy15 weeks, 1 session/week, (2,5 hours.) | Behavioural | 2 |
Primary outcome
Liebowitz Social Anxiety Scale (LSAS)
1 secondary outcome
SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP
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 26 Oct 2010.
- Derived from this study: PubMed 24260145Andersson E, Ruck C, Lavebratt C, Hedman E, Schalling M, Lindefors N, Eriksson E, Carlbring P, Andersson G, Furmark T. Genetic polymorphisms in monoamine systems and outcome of cognitive behavior therapy for social anxiety disorder. PLoS One. 2013 Nov 15;8(11):e79015. doi: 10.1371/journal.pone.0079015. eCollection 2013.
- Derived from this study: PubMed 22320999Hedman E, Andersson E, Ljotsson B, Andersson G, Andersson E, Schalling M, Lindefors N, Ruck C. Clinical and genetic outcome determinants of Internet- and group-based cognitive behavior therapy for social anxiety disorder. Acta Psychiatr Scand. 2012 Aug;126(2):126-36. doi: 10.1111/j.1600-0447.2012.01834.x. Epub 2012 Feb 9.
- Derived from this study: PubMed 21483704Hedman E, Andersson G, Ljotsson B, Andersson E, Ruck C, Mortberg E, Lindefors N. Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: a randomized controlled non-inferiority trial. PLoS One. 2011 Mar 25;6(3):e18001. doi: 10.1371/journal.pone.0018001.
- Information about the study and how to enroll is providedLink provided by the sponsor.
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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.
nils lindefors principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CBT via the Internet and CBT group therapy in people with Social Phobia, run by Karolinska Institutet 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 8 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 26 Oct 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (LSAS). 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 NCT00564967, 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 26 Oct 2010.