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
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
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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 measure
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 (if study stopped)
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
Funders
Funder type
Research organisation
Funder name
Swiss National Science Foundation (Switzerland) Reference number: PP00P1_144824 / 1
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24735420
Publication citations
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Protocol
Schulz A, Stolz T, Berger T, Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial., BMC Psychiatry, 2014, 14, 115, doi: 10.1186/1471-244X-14-115.