Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000236190p
Ethics application status
Not yet submitted
Date submitted
13/02/2019
Date registered
18/02/2019
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Peer Tree: A smartphone application for young people (aged 16-25) with psychosis and other mental health conditions
Scientific title
A randomised control trial of the Peer Tree intervention targeting loneliness in young people with psychosis
Secondary ID [1] 297357 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loneliness 311485 0
Psychosis 311486 0
Condition category
Condition code
Mental Health 310125 310125 0 0
Psychosis and personality disorders
Mental Health 310224 310224 0 0
Schizophrenia
Mental Health 310225 310225 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assessed to determine their eligibility in the study, part of this assessment period is to confirm a psychotic disorder diagnosis. All participants enrolled in the trial will undergo three assessments sessions: baseline (before Peer Tree), post-intervention/end of treatment (immediately after 6week intervention ends), and three months post intervention. After the baseline assessment, participants will be randomised to one of the following two arms:Peer Tree Smartphone Application or Treatment as usual.
Peer Tree Smartphone Application
Participants will use the Peer Tree smartphone application individually for approximately 5-10 minutes per day for 6 consecutive weeks. They will have the flexibility to use the app wherever and whenever they would like, with researchers being able to measure meta-data for adherence to using the smartphone application. The intervention involves short video clips in the form of animations, shared experience videos, actor videos, and expert videos displaying information about different social and emotional processing, and positive psychology principles. The content of the videos include a range of different themes from identifying strengths to expressing gratitude to findings wider meaning.

Participants rate their mood daily and are presented with one video per day. They answer questions about the videos to earn in-app rewards (e.g., tokens/badges to interact with the app). Challenges are provided throughout the intervention to assist participants in exercising the skills they have learnt and to maximise building relationships, these are not compulsory but are encouraged. Participants will also be able to access an online, moderated forum where they can discuss the different topics and challenges within the app. These will be moderated by clinicians, researchers, and peer moderators to ensure the safety of the app users.
Intervention code [1] 313608 0
Treatment: Other
Comparator / control treatment
Treatment as Usual
Participants in this group will undergo treatment as usual as the control condition for testing the Peer Tree Smartphone Application. Treatment as usual here refers to the participants' receiving their regular healthcare service as if they weren't enrolled in the research project. Once the three month post-intervention assessment is held, participants will have access to the content in the form of the previous version of the app, +Connect. +Connect does not include the interactive components and previous research has shown the app to be safe for consumers to use (manuscript under review).
Control group
Active

Outcomes
Primary outcome [1] 319019 0
mean UCLA Loneliness Scale (UCLA-LS)
Timepoint [1] 319019 0
Baseline, End of Treatment, and three-month post intervention
Secondary outcome [1] 366722 0
mean Social Interaction Anxiety Index (SIAS)
Timepoint [1] 366722 0
Baseline, End of Treatment, Three-months post-intervention
Secondary outcome [2] 366723 0
mean Calgary Depression in Schizophrenia Scale (CDSS)
Timepoint [2] 366723 0
Baseline, End of Treatment, Three-months post intervention
Secondary outcome [3] 366725 0
mean Positive and Negative Syndrome Scale (PANSS)
Timepoint [3] 366725 0
Baseline, End of Treatment, Three-Months post-intervention
Secondary outcome [4] 366729 0
mean Positive and Negative Affect Scale (PANAS)
Timepoint [4] 366729 0
Baseline, End of Treatment, Three-Months Post-Intervention
Secondary outcome [5] 366731 0
mean Recovery Assessment Scale (RAS)
Timepoint [5] 366731 0
Baseline, End of Treatment, Three-Month Post-Intervention
Secondary outcome [6] 366732 0
Scales of Psychological Wellbeing (SPWB)
Timepoint [6] 366732 0
Baseline, End of Treatment, Three-Months Post-Intervention
Secondary outcome [7] 366733 0
Assessment of Quality of Life (AQoL 4-D)
Timepoint [7] 366733 0
Baseline, End of Treatment, Three-Months Post-intervention
Secondary outcome [8] 366734 0
mean Social Skills Performance Assessment (SSPA)
Timepoint [8] 366734 0
Baseline, End of Treatment, Three-Month Post-intervention
Secondary outcome [9] 366736 0
mean Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [9] 366736 0
Baseline, End of Treatment, Three-Months Post-Intervention
Secondary outcome [10] 366904 0
adherence assessed by PeerTree meta-data
Timepoint [10] 366904 0
Baseline, End of Treatment, Three-Months Post-Intervention
Secondary outcome [11] 366905 0
mean PeerTree App Acceptability Ratings derived from purpose built questionnaire
Timepoint [11] 366905 0
End of Treatment
Secondary outcome [12] 366993 0
mean Peer Tree app Feasibility ratings derived from purpose built questionnaire
Timepoint [12] 366993 0
End of Treatment
Secondary outcome [13] 366994 0
mean Peer Tree app Usability ratings derived from purpose built questionnaire
Timepoint [13] 366994 0
End of Treatment

Eligibility
Key inclusion criteria
1) Primary diagnosis of a Psychotic Disorder (Schizophrenia, Schizoaffective, Schizophreniform, Brief Psychotic Disorder, Delusional Disorder, Substance Induced Psychotic Disorder, Psychotic Disorder Not Otherwise Specified).
2) Aged between 16 and 25 years
3) Owns a smartphone device (iPhone or Android device)
4) Be engaged with a current mental health organisation of service (or was engaged at time of Baseline Assessment) or be currently engaged with a General Practitioner
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Acutely unwell or recently (e.g., hospitalised within the last 4 weeks for psychiatric reasons, or reports being acutely unwell)
2) Moderate to High Risk Issues (including suicidality and risk of harm to self, others, and objects)
3) Under the age of 16 and over the age of 25
4) Doesn't own a smartphone device
5) Known diagnosis of Personality Disorder
6) Current Substance dependence or abuse

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)
Computerised Sequence Allocation to Random Groups
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
All data processing and analysis will occur either in the statistical package for the Social Sciences (SPSS), Mplus, or R data analysis software. Data manipulation will only occur if the data violates the statistical assumptions for the tests that we would be conducting. In this instance, the data will be transformed into a format that does not jeopardise the interpretability of the scores.

We envisage that any combination of the following will be used to assess the outcomes of the study: Mixed Model ANOVAs, Standard and Hierarchical Regression, Mediation and multiple mediation, latent trajectory modelling, t-tests and comparisons, and finally correlations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
3/01/2021
Actual
Date of last data collection
Anticipated
1/06/2021
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13086 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 25595 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 301963 0
University
Name [1] 301963 0
Swinburne University of Technology
Country [1] 301963 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Swinburne University of Technology,
P O Box 218,
HAWTHORN VIC 3122
Country
Australia
Secondary sponsor category [1] 301734 0
Hospital
Name [1] 301734 0
Eastern Health
Address [1] 301734 0
Eastern Health, Level 4
5 Arnold St, Box Hill
Victoria 3128
Australia
Country [1] 301734 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302607 0
Swinburne University of Technology Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 302607 0
Research Ethics Officer, Swinburne Research (H68),
Swinburne University of Technology,
P O Box 218,
HAWTHORN VIC 3122
Ethics committee country [1] 302607 0
Australia
Date submitted for ethics approval [1] 302607 0
28/03/2019
Approval date [1] 302607 0
Ethics approval number [1] 302607 0
Ethics committee name [2] 302614 0
Eastern Health Human Research Ethics Committee
Ethics committee address [2] 302614 0
Eastern Health, Level 4
5 Arnold St, Box Hill
Victoria 3128
Australia
Ethics committee country [2] 302614 0
Australia
Date submitted for ethics approval [2] 302614 0
28/03/2019
Approval date [2] 302614 0
Ethics approval number [2] 302614 0

Summary
Brief summary
The aim of the research project is to deliver and test an innovative digital smartphone intervention, Peer Tree, which is designed to reduce loneliness in young people with psychosis and other mental health conditions. The intervention is administered daily for 6 weeks.

Young people aged 16-25 years who report high levels of loneliness and have a diagnosis of a psychotic disorder or a different disorder that has psychotic features will be recruited. In accordance with a randomised control trial study design, after participants complete the baseline assessment, they will be randomised to either the treatment as usual or intervention group. Those in the waitlist group will complete treatment as usual but will be provided with the same content once they have completed the research project. This will be provided in the form of +Connect, the predecessor of Peer Tree that doesn’t not contain the forums.

Our research is expected to contribute to the development of personalised, modular mental health interventions that are cost-effective and efficient. There are currently no personalised, modular interventions available to address loneliness in young people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90802 0
Dr Michelle Lim
Address 90802 0
Swinburne University of Technology
John Street, Hawthorn, VIC, 3122, Australia
Country 90802 0
Australia
Phone 90802 0
+61 3 9214 5109
Fax 90802 0
Email 90802 0
[email protected]
Contact person for public queries
Name 90803 0
Dr Robert Eres
Address 90803 0
Swinburne University of Technology
John Street, Hawthorn, VIC, 3122, Australia
Country 90803 0
Australia
Phone 90803 0
+61 392144868
Fax 90803 0
Email 90803 0
[email protected]
Contact person for scientific queries
Name 90804 0
Dr Michelle Lim
Address 90804 0
Swinburne University of Technology
John Street, Hawthorn, VIC, 3122, Australia
Country 90804 0
Australia
Phone 90804 0
+61 3 9214 5109
Fax 90804 0
Email 90804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our ethics board do not allow for individual participant data to be provided. Only data presented at the group level can be made readily available.


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.