Condition category
Mental and Behavioural Disorders
Date applied
09/06/2016
Date assigned
06/07/2016
Last edited
13/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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, however, whether these treatments can be even more effective when provided though smartphones, making it easier for people to use as they go about their daily routine. This study is looking at whether patients are more likely to use an internet-based SAD treatment program delivered to a smartphone during the day, in different settings, and whether it results in a more successful treatment when compared to the same treatment that can only be accessed through a PC.

Who can participate?
Adults (aged at least 18) that suffer from anxiety in social situations.

What does the study involve?
Participants are randomly allocated to one of three groups. All groups receive access to the web-based treatment but at different time points. Group 1 receive a web-based self-help treatment along with individual therapist support via email. Group 2 receive the same self-help materials, but sent to them on their smartphones. Group 3 receive the same materials as group 2 but only after 12 weeks (at the end of the study).

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 (treatments) 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 smartphone delivery improves the treatment outcome.

Where is the study run from?
The intervention is delivered via the internet. Thus, participants have to go on the website: http://www.online-therapy.ch/studie2.
The study is run from the University of Bern (Switzerland)

When is the study starting and how long is it expected to run for?
November 2014 to November 2016

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

Trial website

https://www.online-therapy.ch/studie2

Contact information

Type

Scientific

Primary contact

Prof Thomas Berger

ORCID ID

Contact details

Fabrikstrasse 8
Bern
3012
Switzerland
0041316313407
thomas.berger@ptp.unibe.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Internet-based guided self-help for social anxiety disorder administered through a mobile app: a randomized controlled trial

Acronym

Study hypothesis

The primary aim of the study is to investigate whether smartphone-delivery leads to facilitated usage in daily routine, and whether this has a positive effect on the treatment outcome compared to Internet-based guided self-help for social anxiety disorder (SAD). To test this question, we will compare a condition with pc-based guided self-help with a condition of mobile 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 smartphone-support will be superior to the condition with the pc-based program 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 usage patterns) and economic aspects regarding the estimated cost of each treatment condition will be examined.

Ethics approval

Cantonal Ethics Committee Bern, 13/05/2014, ref: 063/14

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

See additional files

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 for 12 weeks
2. Second active condition: the same self-help materials, including guidance, but administered through smart-phones for 12 weeks
and
3. Wait-list control group

The self-help materials include psychoeducation about social anxiety disorder, cognitive restructuring of maladaptive beliefs, and both relaxation and exposure exercises. All participants are followed-up for three months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Symptoms of SAD (Social Phobia Scale [SPS], assessed using Social Interaction Anxiety Scale [SIAS], and 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, assessed using the Beck Depression Inventory [BDI-II]: pre, post (12 weeks), follow-up (6 months)
2. General symptomatology, assessed using the Brief Symptom Inventory [BSI]: pre, post (12 weeks), follow-up (6 months)
3. Interpersonal problems, assessed using the Inventory of Interpersonal Problems (IIP-64): pre, post (12 weeks), follow-up (6 months)
4. Quality of life, assessed using the SF-12 Health Survey: pre, post (12 weeks), follow-up (6 months)
5. Client Satisfaction, assessed using the ZUF-8 general satisfaction questionnaire: post (12 weeks)
6. Several process measures:
6.1. Change in SAD symptoms: week 2, 4, 6, 8, 10
6.2. Individual condition, assessed using the Working Alliance Inventory-Short Revised (WAI-SR): week 2, 4, 6, 8, 10
6.3. Treatment expectancy, assessed using the Credibility/Expectancy Questionnaire (CEQ): week 2

Overall trial start date

01/11/2014

Overall trial end date

30/11/2016

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

24/11/2014

Recruitment end date

18/05/2016

Locations

Countries of recruitment

Switzerland

Trial participating centre

University of Bern
Bern
3012
Switzerland

Sponsor information

Organisation

Swiss National Science Foundation

Sponsor details

Abteilung Karrieren
SNF-Förderungsprofessuren
Wildhainweg 3
Postfach 8232
Bern
3012
Switzerland
+41 31 308 22 22
com@snf.ch

Sponsor type

Research organisation

Website

http://www.snf.ch

Funders

Funder type

Not defined

Funder name

Swiss National Science Foundation (Switzerland) Reference number: PP00P1_144824 / 1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/07/2016: Added participant information sheet