Clinical trial NCT00564967: A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Social Phobia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2007-11-29
Enrollment: 128
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* Must have a primary diagnosis of social phobia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS)
Secondary outcomes:
measure: SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri Sydväst, Stockholm County Council
Study officials:
affiliation: Karolinska Institutet
name: nils lindefors
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hedman 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.
citation: Hedman 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.