Internet-based guided self-help for social anxiety disorder administered through a mobile app
| ISRCTN | ISRCTN10627379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10627379 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/06/2016
- Registration date
- 06/07/2016
- Last edited
- 22/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Fabrikstrasse 8
Bern
3012
Switzerland
| Phone | +41 (0)316313407 |
|---|---|
| thomas.berger@ptp.unibe.ch |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | ISRCTN10627379_PIS_German_29Jun16.pdf |
| Scientific title | Internet-based guided self-help for social anxiety disorder administered through a mobile app: a randomized controlled trial |
| Study objectives | 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(s) | Cantonal Ethics Committee Bern, 13/05/2014, ref: 063/14 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2014 |
| Completion date | 30/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/11/2014 |
| Date of final enrolment | 18/05/2016 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
3012
Switzerland
Sponsor information
Research organisation
Abteilung Karrieren
SNF-Förderungsprofessuren
Wildhainweg 3
Postfach 8232
Bern
3012
Switzerland
| Phone | +41 (0)31 308 22 22 |
|---|---|
| com@snf.ch | |
| Website | http://www.snf.ch |
"ROR" |
https://ror.org/00yjd3n13 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/06/2016 | 13/07/2016 | No | Yes | |
| Results article | results | 01/06/2018 | Yes | No |
Additional files
- ISRCTN10627379_PIS_German_29Jun16.pdf
- - uploaded 13/07/2016
Editorial Notes
22/05/2018: Publication reference added.
13/07/2016: Added participant information sheet
