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Trial registered on ANZCTR


Registration number
ACTRN12616000365460p
Ethics application status
Submitted, not yet approved
Date submitted
9/03/2016
Date registered
21/03/2016
Date last updated
21/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of mobile 'apps' as treatment for social anxiety in university students: A randomised controlled trial.
Scientific title
The use of mobile 'apps' as treatment for social anxiety in university students: A randomised controlled trial.
Secondary ID [1] 288715 0
None
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety 297950 0
depression 297951 0
Condition category
Condition code
Mental Health 298111 298111 0 0
Anxiety
Mental Health 298112 298112 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to either a control group or one of two experimental groups: the SAM or “What’s Up” mobile phone app group and instructed to use it according to a strict schedule provided to them.

What’s Up
App containing Acceptance and Commitment (ACT) mindfulness based therapies. Contains instruction metaphorical thinking, thinking patterns and management of worries. Also contains a set of ‘emergency’ techniques for anxiety/panic management which are breathing and muscle relaxation techniques. Each section contains a brief description of the intended strategies, followed by explicit instruction for each one. Designed and uploaded to the Apple and Google Play stores by Jackson Tempra. There is no additional information available on Mr. Tempra, the app information weblink leads to a Facebook page with information concerning app updates, but no development information or evidence. (https://www.facebook.com/whatsupsapp/). Apps will be used via a touch screen mobile device such as a tablet or mobile smart phone owned by participants.

SAM
App containing Cognitive Behavioural Therapy (CBT) based therapies. Contains instruction on physical and mental relaxation, as well as an anxiety tracker function, records of situations stimuli that cause anxiousness - to be completed by users and finally a set of breathing and muscle relaxation techniques to be used in an ‘emergency’ anxiety situation. Each activity includes a predicted amount of time for completion and the ‘level’ of difficulty developers consider that activity to be. Designed and uploaded by the University of West England. There is a weblink provided in the app that leads to a website containing basic information such as download links, contact details and key features. (http://sam-app.org.uk). Apps will be used via a touch screen mobile device such as a tablet or mobile smart phone owned by participants.

CONTROL GROUP
Will not receive any app and will only be required to refrain from beginning to use a self-help app of their own accord or begin psychological treatment during this period.

Treatment Period: 4 weeks.
Regimen: SAM group - 2 hours of app use weekly, for a period of 4 weeks.
Week 1 - Relaxation Physical:

Calm breathing - 5 minute duration.
Muscle relaxation (tense and relax exercise) - 10 minutes.
Progressive muscle relaxation - 1-5 minutes.
Ground Yourself 1 - touching your environment and objects in order to take control of anxiety) - 5-10 minutes.
Ground Yourself 2 (associating body movement with relaxed memories) - 1-5 minutes.

Week 2 - Relaxation Mental:

The worry half-hour (set aside time to deal with worries and anxiety however you see fit) - 30 minutes.
Picture peace (select picture from provided gallery and uncover it by rubbing across screen. Can be done multiple times) - 1-5 minutes.
It’s only a thought (add worrying thoughts to app and then float them away with a button) - 1-5 minutes.
A worry shared (talk to someone about anxiety) - 1-5 minutes.
Simple meditation - 20 minutes.
Stop that thought (add worry to app and then tap it to make it explode) - 1 minute.

Week 3 - Combined Relaxation Physical and Mental strategies:

Participants can pick any of the activities in any combination and perform them for the 2 hour period that week.

Week 4 - Combined Relaxation Physical and Mental strategies:

Participants can pick any of the activities in any combination and perform them for the 2 hour period that week.

Activities are determined by what section of the app is allocated to participants each week. Further than that, participants will be able to choose which ever activity suits their needs and schedule the best as they vary on duration and level of practice required.

What’s Up group - 2 hours of app use weekly, for a period of 4 weeks.
Week 1 - Thinking Patterns:

List of maladaptive thought patterns common to anxiety disorders allowing participants to identify which patterns are relevant to each participant and a positive alternative way of thinking. E.g. Catastrophising - imagining the worst that could happen, recognising that it’s not helpful and asking yourself what is most likely to happen.

Week 2 - Metaphors:

List of strategies focused on providing alternate ways of viewing negative thoughts. E.g. Passenger on the bus (imagine you are a bus driver and the noisy passengers are negative thoughts, you allow them to keep shouting but continue on anyway).

Week 3 - Manage Worries:

List of strategies for managing worries when they begin to interfere with life activities such as sleeping. E.g. Repeat your worry until you are bored silly, set aside worry time.

Week 4 - Manage Worries:

Same as week 3, participants will continue on with the activities they found helpful or try new ones as they see fit.

Participants will be given an app use diary, but ultimately it will be left to the individual to monitor and record their own use. The diary is an excel spreadsheet that will be returned to the Senior Supervisor at the conclusion of the treatment phase. Control group will not be provided with any monitoring documents.
Intervention code [1] 294151 0
Treatment: Other
Comparator / control treatment
The control group will not receive information about the mobile phone apps.
Control group
Active

Outcomes
Primary outcome [1] 297619 0
Level of social anxiety as assessed by participant scores on the Brief Social Phobia Scale (BSPS).
BSPS.
Timepoint [1] 297619 0
4 weeks
Primary outcome [2] 297620 0
Level of general anxiety as assessed by the Depression, Anxiety and Stress Scales (DASS).
DASS.
Timepoint [2] 297620 0
4 weeks
Secondary outcome [1] 321606 0
Depression as assessed by the Depression, Anxiety and Stress Scales (DASS).
DASS.
Timepoint [1] 321606 0
4 weeks

Eligibility
Key inclusion criteria
Written, informed consent obtained.
Men and women over 18 years of age.
Currently enrolled student at RMIT university.
Score of 20+ on Brief Social Phobia Scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Score of 4+ on the Simple Screening Instrument - Substance Abuse.
Previous experience with CBT, ACT or mindfulness therapy.
Currently undergoing CBT/ACT/Mindfulness therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed with a mixed measures/split-plot ANOVA. This will allow for each app to be evaluated for treatment effect and a comparison to be made between the apps to identify which one, if any is better. This will be conducted following the final participant’s completion of the 4 week trial period.
Power analysis: An examination of previous RCT in the area of internet interventions was conducted and an average was calculated based on their sample sizes. Sample size was then increased to 45 to allow for possible attrition issues. Gender imbalance was determined according to past literature which indicated that females experience social anxiety more than males.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2016
Actual
Date of last participant enrolment
Anticipated
30/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 12852 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 293072 0
University
Name [1] 293072 0
RMIT University, School of Health and Biomedical Sciences
Country [1] 293072 0
Australia
Primary sponsor type
University
Name
RMIT University, School of Health and Biomedical Sciences
Address
RMIT University
School of Health and Biomedical Sciences
PO Box 71, Bundoora, VIC, 3083
Country
Australia
Secondary sponsor category [1] 291853 0
None
Name [1] 291853 0
Address [1] 291853 0
Country [1] 291853 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294580 0
RMIT HREC
Ethics committee address [1] 294580 0
Ethics committee country [1] 294580 0
Australia
Date submitted for ethics approval [1] 294580 0
29/02/2016
Approval date [1] 294580 0
Ethics approval number [1] 294580 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64234 0
Dr Mirella Di benedetto
Address 64234 0
RMIT University
School of Health and Biomedical Sciences
PO Box 71, Bundoora, VIC, 3083
Country 64234 0
Australia
Phone 64234 0
+61 3 9925 3019
Fax 64234 0
+61 3 9925 6539
Email 64234 0
[email protected]
Contact person for public queries
Name 64235 0
Mirella Di Benedetto
Address 64235 0
RMIT University
School of Health and Biomedical Sciences
PO Box 71, Bundoora, VIC, 3083
Country 64235 0
Australia
Phone 64235 0
+61 3 9925 3019
Fax 64235 0
+61 3 9925 6539
Email 64235 0
[email protected]
Contact person for scientific queries
Name 64236 0
Mirella Di Benedetto
Address 64236 0
RMIT University
School of Health and Biomedical Sciences
PO Box 71, Bundoora, VIC, 3083
Country 64236 0
Australia
Phone 64236 0
+61 3 9925 3019
Fax 64236 0
+613 9925-6539
Email 64236 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.