NCT00564967

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 26, 2010

Status Verified

August 1, 2009

Enrollment Period

2.8 years

First QC Date

November 28, 2007

Last Update Submit

October 25, 2010

Conditions

Social Phobia

Outcome Measures

Primary Outcomes (1)

  • Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcomes (1)

  • SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP

Study Arms (2)

1

EXPERIMENTAL

CBT via the Internet

Behavioral: CBT via the Internet

2

EXPERIMENTAL

15 weeks, CBT group therapy, 1 session/week (2.5 hours).

Behavioral: CBT group therapy

Interventions

CBT via the InternetBEHAVIORAL

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),

1
CBT group therapyBEHAVIORAL

15 weeks, 1 session/week, (2,5 hours.)

2

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a primary diagnosis of social phobia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psykiatri Sydväst, Stockholm County Council

Stockholm, Stockholm County, 141 86, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 24260145DERIVED

  • 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.

    PMID: 22320999DERIVED

  • 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.

    PMID: 21483704DERIVED

Related Links

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • nils lindefors

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

November 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 26, 2010

Record last verified: 2009-08

Locations

SE(1)