A Comparison Between Internet-based Self-help Therapy and Group Therapy for Social Phobia - A Clinical Equivalence Trial Using Cognitive Behavioural Therapy (CBT)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Liebowitz Social Anxiety Scale (LSAS)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- 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
Outcomes
Primary Outcomes
Liebowitz Social Anxiety Scale (LSAS)
Secondary Outcomes
- SIAS, SPS,QOLI,MADRS-S, BAI,ASI,CGI, WQ, GAF, TIC-P, SSP