Plain English Summary
Background and study aims
Agoraphobia is a type of anxiety disorder where a person fears being in situations and places where they feel trapped or in danger, often because of openness or crowdedness. Although many believe it is just a fear of open or public places, it is much more complex and usually involves a range of different fears. In general, it can render people unable to function and the condition traps sufferers in a vicious cycle, preventing them from leaving home to seek the support or to attend treatment that might end the condition. Depending on how severe the condition is treatment may require one-to-one therapy in a patient's home and for the person to be escorted around the surrounding area, but this is often expensive and time-consuming. "Agoraphobia Free" is a new therapeutic app which aims to break this cycle by putting the two components of traditional treatment, namely education and exposure therapy (gradually exposing someone to their fear until it no longer scares them), in the hands of the users themselves via their phones or tablets. This study aims to look at the effectiveness of using the app for six weeks on the severity of symptoms in self-reported agoraphobia sufferers.
Who can participate?
Adults who suffer from agoraphobia.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given access to the “Agoraphobia Free” app, which is designed specifically to help people with agoraphobia, for a total of 12 weeks. The app features game play to make therapy sessions as engaging as possible, exposing users to virtual environments likely to trigger their fears. They are also taught ways of dealing with their fears within the app so that they are no longer as frightening. Those in the second group are given access to a more generalized app called “Stress Free”, which is designed to help people with anxiety in general, for a total of 12 weeks. This app involves teaching the user techniques such as calm breathing, relaxation and meditation, designed to lower anxiety levels. At the start of the study and then again after six and 12 weeks, participants in both groups complete a number of questionnaires in order to assess the severity of their agoraphobia symptoms.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their feelings of anxiety as well as increased knowledge about their condition. There are no notable risks of taking part in the study.
Where is the study run from?
University of Roehampton (UK)
When is the study starting and how long is it expected to run for?
September 2014 to April 2015
Who is funding the study?
Nominet Trust (UK)
Who is the main contact?
Dr Elias Tsakanikos
Study website
Contact information
Type
Scientific
Contact name
Dr Elias Tsakanikos
ORCID ID
http://orcid.org/0000-0002-7792-5402
Contact details
Centre of Research in Individual Differences (CRID)
Department of Psychology
Roehampton University
Holybourne Avenue
London
SW15 4JD
United Kingdom
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
N/A
Study information
Scientific title
Clinical effectiveness of a mobile phone application to treat agoraphobia with and without panic disorder (PD) in a community-based sample
Acronym
Evaluation of Agoraphobia Free
Study hypothesis
The aim of this study is to examine whether the agoraphobia-specific mobile intervention ("agoraphobia-free") is more effective than the generic, control intervention ("stress free").
Ethics approval(s)
Roehampton University Ethics Committee, 21/05/2014, ref: PSYC 14/ 117
Study design
Web-based assessor-blind randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Internet/virtual
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Agoraphobia/Agoraphobic anxiety
Intervention
Adults that self-identified with agoraphobia were randomised to the two treatment arms. Block randomisation was applied to ensure equal numbers of participants in each group (ratio 1:1).
Group 1: Participants are given access to the “Agoraphobia Free” app developed by Health e-Living Partnership Ltd. (HeLP) for iOS and Android. The app involves an interactive game-based intervention utilising cognitive-behavioural techniques that target agoraphobia.
Group 2: Participants are given access to a generic stress-reduction application (“Stress Free”), which does not specifically address agoraphobic symptoms. The app aims to help to lower anxiety levels through techniques such as calm breathing, differential deep muscle relaxation, self-hypnosis and meditation
Participants in both groups are given access to the application for a total of 12 weeks, and complete self-reported assessments at baseline, midpoint (6 weeks) and endpoint (12 weeks) of the trial.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
Severity of agoraphobic and panic symptoms are measured using the Panic and Agoraphobia Scale at baseline, 6 and 12 weeks.
Secondary outcome measures
1. Degree of subjective distress experienced because of agoraphobia is measured by using a single item (“How much distress have you experienced because of agoraphobia in the past week?”), which is rated from 1 (“No distress”) to 5 (“Extreme distress”) at baseline, 6 and 12 weeks
2. Completion of the intervention is measured as 1 (completion of the tasks) or 0 (non-completion of the tasks) at 6 and 12 weeks
3. Engagement with the apps is measured using app usage data (i.e. total number of times that users engaged with the app) at 6 and 12 weeks
Overall study start date
24/09/2014
Overall study end date
23/04/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 or above
2. Identify themselves as suffering from agoraphobia
3. Willing and able to provide informed consent to participate
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
170
Participant exclusion criteria
1. Inability to give informed consent due to significant cognitive or intellectual impairment
2. No adequate understanding of English as a first language
3. Not having a mobile device than can run the application as designed
4. Any significant disease or disorder which, in the opinion of the Investigators, may either put the person at risk because of participation in the trial.
Recruitment start date
22/09/2014
Recruitment end date
28/04/2015
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University of Roehampton
Whitelands College
Holybourne Avenue
London
SW15 4JD
United Kingdom
Sponsor information
Organisation
University of Roehampton
Sponsor details
Department of Psychology
University of Roehampton
Holybourne Avenue
London
SW15 4JD
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Nominet Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication of study results.
Intention to publish date
31/03/2016
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 24/11/2017 | Yes | No |