A Comparison Between Internet Therapy and Group Therapy for Social Phobia - A Trial Using Cognitive Behavioural Therapy (IS1)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Social Phobia |
Behavioral: CBT via the Internet Behavioral: CBT group therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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) |
- Liebowitz Social Anxiety Scale (LSAS) [ Designated as safety issue: No ]
- SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP [ Designated as safety issue: No ]
| Estimated Enrollment: | 128 |
| Study Start Date: | November 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
CBT via the Internet
|
Behavioral: 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),
|
|
Experimental: 2
15 weeks, CBT group therapy, 1 session/week (2.5 hours).
|
Behavioral: CBT group therapy
15 weeks, 1 session/week, (2,5 hours.)
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided by Karolinska Institutet
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nils Lindefors, MD, PHD, professor, Stockholm County Council and Karolinska Institute |
| ClinicalTrials.gov Identifier: | NCT00564967 History of Changes |
| Other Study ID Numbers: | IS1, Dnr 2005/178-31 |
| Study First Received: | November 28, 2007 |
| Last Updated: | October 25, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Additional relevant MeSH terms:
|
Phobic Disorders Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013