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A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy (IS1)

Primary Purpose

Social Phobia

Status

Completed

Phase

Phase 3

Locations

Sweden

Study Type

Interventional

Intervention

CBT via the Internet

CBT group therapy

About this trial

This is an interventional treatment trial for Social Phobia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Psykiatri Sydväst, Stockholm County Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

CBT via the Internet

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

Outcomes

Primary Outcome Measures

Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00564967

First Posted

November 28, 2007

Last Updated

October 25, 2010

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT00564967

Brief Title

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

Acronym

IS1

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

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Social Phobia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

CBT via the Internet

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

CBT via the Internet

Intervention Description

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

Intervention Name(s)

CBT group therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Liebowitz Social Anxiety Scale (LSAS)

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nils lindefors

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Psykiatri Sydväst, Stockholm County Council

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24260145

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. Erratum In: PLoS One. 2016 Oct 18;11(10 ):e0165249.

Results Reference

derived

PubMed Identifier

22320999

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.

Results Reference

derived

PubMed Identifier

21483704

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.

Results Reference

derived

Links:

URL

http://www.internetpsykiatri.se

Description

Information about the study and how to enroll is provided

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

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