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A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy

NCT ID: NCT00564967

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Social Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

CBT via the Internet

Group Type EXPERIMENTAL

CBT via the Internet

Intervention Type BEHAVIORAL

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),

2

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

Group Type EXPERIMENTAL

CBT group therapy

Intervention Type BEHAVIORAL

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

Interventions

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CBT via the Internet

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),

Intervention Type BEHAVIORAL

CBT group therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Stockholm County Council and Karolinska Institute

Principal Investigators

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nils lindefors

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Psykiatri Sydväst, Stockholm County Council

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 24260145 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22320999 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21483704 (View on PubMed)

Related Links

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http://www.internetpsykiatri.se

Information about the study and how to enroll is provided

Other Identifiers

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Dnr 2005/178-31

Identifier Type: -

Identifier Source: secondary_id

IS1

Identifier Type: -

Identifier Source: org_study_id