ISRCTN - ISRCTN75894275: Internet-based individually guided versus group-guided self-help treatment for Social Anxiety DIsorder

Plain English Summary

Background and study aims
Social anxiety disorder (SAD) is one of the most common mental disorders. Although effective treatments exist, a lot of people do not receive professional help. Internet-based treatments are an easily accessible alternative and have been shown to be effective in treating SAD. It remains unclear how much support is needed during an internet-based treatment. This study aims at investigating if the patients' mutual support via a discussion forum will increase the treatment success of a web-based intervention.

Who can participate?
150 people will participate. To participate you must suffer from anxiety in social situations. Furthermore, participants have to be at least 18 years old, need access to the internet and have sufficient German language skills. Participants cannot undergo any other psychological treatment for the duration of the study. The study does not apply to persons with severe psychiatric disorders such as psychotic or bipolar disorder.

What does the study involve?
Participants will be randomly allocated to one of three groups. All groups will receive access to the web-based treatment but at different time points. Group 1 will receive a web-based self-help approach with individual therapist support conducted via email. Group 2 will receive the same web-based self-help approach, but with therapist-guided group support (six participants working together with the self-help program). Group 3 will receive the same intervention as group 2 but after 12 weeks.

What are the possible benefits and risks of participating?
Possible benefits of the study are the reduction of symptoms of SAD. Previous studies have shown that users of the web-based interventions felt better and more content after the treatment. There are no known negative side effects related to the treatment. However, it is unclear to what extent support by other participants improves the treatment outcome.

Where is the study run from?
The intervention is delivered via the internet. Thus, participants have to go on our website: http://www.online-therapy.ch/studie.The study will be run from the University of Bern, Switzerland.

When is the study starting and how long is it expected to run for?
The study will start in November 2013 and will continue to recruit participants until June 2014. The study will run until November 2014.

Who is the main contact?
Prof. Dr Thomas Berger
thomas.berger@ptp.unibe.ch

Trial website

http://www.online-therapy.ch/studie

Contact information

Type

Scientific

Primary contact

Prof Thomas Berger

ORCID ID

Contact details

Clinical Psychology and Psychotherapy
University of Bern
Fabrikstrasse 8
Bern
3012
Switzerland
-
thomas.berger@ptp.unibe.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Internet-based individually guided versus group-guided self-help treatment for Social Anxiety DIsorder: a randomized controlled trial

Acronym

SADI

Study hypothesis

The primary aim of the study is to investigate whether peer support in small groups of six participants has a positive effect on the treatment outcome of Internet-based guided self-help for Social Anxiety Disorder (SAD). To test this question, we will compare a condition with individually guided self-help with a condition with group-guided self-help and a wait-list control group. It is assumed that both active conditions show a greater reduction of social phobic symptoms than the wait-list control condition and that the condition with additional peer support will be superior to the condition with individual support regarding social phobic symptoms and diagnostic status. Furthermore, we will conduct exploratory analyses to identify potential predictors, moderators and mediators of treatment outcome (such as treatment expectation and adherence to treatment). In addition, variables of the treatment process (such as group processes in the peer group condition) and economic aspects regarding the estimated cost of each treatment condition will be examined.

Ethics approval

Cantonal Ethics Committee Bern, 14/06/2013, Nr. 062/13

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the following link to request the patient information sheet: http://www.online-therapy.ch/studie

Condition

Social Anxiety Disorder

Intervention

A randomized controlled trial aiming at investigating the additional value of therapist-guided peer support in small groups on the treatment outcome of a web-based self-help intervention for SAD.

Two active conditions:
1. First active condition: web-based self-help approach with individual therapist support conducted via email
2. Second active condition: the same web-based self-help approach, but with therapist-guided group support (six participants working together with the self-help program)
3. Wait-list control group

Total duration of the interventions: 12 weeks.
Timepoints of assessment for primary outcomes: pre-intervention, post-intervention (12 weeks), follow-up (6 months)
The wait-list group will receive the group-guided intervention after 12 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Symptoms of SAD (Social Phobia Scale [SPS], Social Interaction Anxiety Scale [SIAS], Liebowitz Social Anxiety Scale-Self-Report [LSAS-SR]): pre, post (12 weeks), follow-up (6 months)
2. Diagnostic status (Structured Clinical Interview for DSM-IV Axis I Disorders [SCID-I]): pre, post (12 weeks), follow-up (6 months)

Secondary outcome measures

1. Depression (Beck Depression Inventory [BDI-II]): pre, post (12 weeks), follow-up (6 months)
2. General symptomatology (Brief Symptom Inventory [BSI]): pre, post (12 weeks), follow-up (6 months)
3. Interpersonal problems (IIP-64): pre, post (12 weeks), follow-up (6 months)
4. Quality of life (SF-12): pre, post (12 weeks), follow-up (6 months)
5. Client Satisfaction (ZUF-8): post (12 weeks)
6. Several process measures:
6.1. Change in SAD symptoms: week 2, 4, 6, 8, 10
6.2. Individual condition - Working Alliance Inventory-Short Revised (WAI-SR): week 2, 4, 6, 8, 10
6.3. Peer support condition - group processes (GQ-D): week 2, 4, 6, 8, 10
6.4. Treatment expectancy - Credibility/Expectancy Questionnaire (CEQ): week 2

Overall trial start date

11/11/2013

Overall trial end date

11/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female at least 18 years of age
2. Provided written consent
3. Sufficient German language skills
4. Access to computer with internet connection
5. Exceeding pre-defined cut-off scores in one of the social anxiety measures
6. Meeting the diagnostic criteria for SAD according to the diagnostic telephone interview
7. Agreeing to undergo no other psychological treatment for the duration of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Active suicidal plans (according to the suicide item of the Beck Depression Inventory (BDI) or the diagnostic telephone interview)
2. History of psychotic or bipolar disorders
3. Prescribed medication for anxiety or depression only if the dosage has been changed during the last month prior to the study

Recruitment start date

11/11/2013

Recruitment end date

11/06/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of Bern
Bern
3012
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation (Switzerland)

Sponsor details

Abteilung Karrieren
SNF-Förderungsprofessuren
Wildhainweg 3
Postfach 8232
Bern
3012
Switzerland

Sponsor type

Research organisation

Website

http://www.snf.ch

Funders

Funder type