Condition category
Mental and Behavioural Disorders
Date applied
16/06/2015
Date assigned
11/07/2015
Last edited
26/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Social phobia is a mental disorder with an early onset and chronic course , which has a significant negative effect on the lives of sufferers . Among the most common symptoms are palpitations, excessive sweating , trembling and blushing, in addition to avoidance of social situations and performance. One of the most commonly used treatments is the live exposure, involving confronting the fear of social occasions by placing the patients in those situations. Recently virtual reality, which uses 3D imagery, has emerged as an effective alternative treatment because it leads to a sense of strong immersion in the virtual environment , and is conducted so that the scenes can be seen a considerable number of times. . This study will compare these two treatments. It is expected that both work equally well at treating of social phobia .

Who can participate?
Adults suffering from social phobia who have enrolled in the Anxiety Program and the Psychotherapy Service of Department and Institute of Psychiatry, University of São Paulo.

What does the study involve?
Each patient is randomly placed into one of two groups. Those in group 1 receive virtual reality exposure therapy. Those in group 2 receive live exposure therapy. Patients of both groups will be submitted to 12 sessions once a week and 3 months evaluation follow up

What are the possible benefits and risks of participating?
Benefits: Reduction of social anxiety.
Risks: The procedures applied offer minimum discomfort or risk to the patient’s health. Among them is the risk of feeling anxious during the sessions of exposure to social situations. However this risk is small since, in both groups, exposure is performed slowly . Moreover, this anxiety is necessary for improvement.

Where is the study run from?
Department and Institute of Psychiatry, University of São Paulo (Brazil)

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

Who is funding the study?
The Anxiety Program at the Department and Institute of Psychiatry, University of São Paulo (Brazil) and FAPESP, a research support foundation.

Who is the main contact?
Tito Paes de Barros Neto
tito.barrosneto@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Professor Francisco Lotufo Neto

ORCID ID

Contact details

Dr. Ovídio Pires de Campos
785
São Paulo
05403-903
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Virtual reality exposure in social phobia patients: a controlled clinical trial

Acronym

Study hypothesis

Main hypothesis: Virtual reality exposure to treat social phobia program (RVFS PROGRAM) is as effective as live exposure in the treatment of social phobia.

Secondary hypothesis:
Participants RVFS PROGRAM will present at the end of treatment:
1. Greater adherence to treatment;
2. Exposure time for the occurrence of lower habituation ;
3. Shorter duration of therapy;
4. Greater improvement in depressive symptoms and social adjustment ;
5. Satisfaction with treatment is greater;
6. Bond with the therapist is better;
7. The lower disability ;
8. More exhibitions. Here it is important to point out that the scenes of RVFS PROGRAM can be viewed and reviewed by the patients a lot of times , thereby increasing the effectiveness of exposure by repeating the scenes.

Ethics approval

Coordinating body of research ethics (ECA) Department and Institute of Psychiatry, University of São Paulo, 11/03/2015, ref: 981.031

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Social phobia (SP)

Intervention

82 patients with social phobia diagnosis will be randomly distributed into two treatment groups: virtual exhibition or live exposure. Therapists with expertise in cognitive behavioral therapy will be responsible for treating these patients . Each group has a protocol to be followed by the therapists. There will be 12 sessions of therapy for each patient.

Intervention type

Phase

Drug names

Primary outcome measures

Efficacy will be assessed by:
1. Down 25% to 50% in the LSAS scores will be considered partial response, and above 50% remission
2. Clinical Global Impression presenting scores 0 or 1 on the subscales of severity and improves
3. Sheehan Disability Scale presenting scores 0-3 in each of the three subscales (Work, Social Life and Family Life)


Secondary outcome measures

Secondary measures:
1. Accession shall be assessed by the number of dropouts
2. The habituation, decreased anxiety during the exposure procedure is assessed by the duration in minutes for the sessions that subjective discomfort units fall from 25% to 50%
3. The duration of therapy will be evaluated by the number of sessions required for habituation to occur
4. Depressive symptoms will be assessed by the Beck Depression Inventory for (BDI) considering improves a lower score than 10
5. Improved quality of life will be assessed by Scale Social-EAS Adequacy (Weissman and Bothwell, 1976)
6. Customer satisfaction with treatment will be evaluated by CSQ-8
7. The therapeutic alliance (bond) will be evaluated by WAI

Overall trial start date

08/07/2014

Overall trial end date

16/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Treated at the Psychotherapy Service and Anxiety Program (AMBAN)
2. Aged 18 - 65
3. Can read and write
4. Diagnosised with FS , according to the DSM -5

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

82 patients, 41in the virtual reality exposure group and 41in the live exposure group

Participant exclusion criteria

Patients:
1. With severe major depression
2. At risk for suicide, substance abuse or dependence psychotic disorders
3. Who are in psychotherapy

Recruitment start date

03/08/2015

Recruitment end date

03/02/2016

Locations

Countries of recruitment

Brazil

Trial participating centre

Psychotherapy Service and Anxiety Program of the Department and Institute of Psychiatry, University of São Paulo
Rua Dr. Ovídio Pires de Campos 785 São Paulo
05403-903
Brazil

Sponsor information

Organisation

Anxiety Program at the Institute of Psychiatry Faculty of Medicine University of São Paulo

Sponsor details

Institute of Psychiatry HCFMUSP
Rua Dr. Ovidio Pires de Campos
785
Cerqueira Cesar
São Paulo
Brazil
São Paulo
05403-903
Brazil

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Anxiety Program at the Institute of Psychiatry Faculty of Medicine University of São Paulo (Brazil).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Support Foundation (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes