ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000942358

Ethics application status

Approved

Date submitted

23/06/2017

Date registered

30/06/2017

Date last updated

14/03/2023

Date data sharing statement initially provided

14/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Altitudes East-West: Effectiveness of a Moderated Online Social Therapy program for First Episode Psychosis carers

Scientific title

A randomised controlled trial of Moderated Online Social Therapy for carers of early psychosis clients in real world settings

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1197-2961

Trial acronym

Altitudes East West

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perceived stress

Objective Stress

Depression

Substance use

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Altitudes is a world-first online application, designed and built utilising our Moderated Online Social Therapy (MOST) software framework, which integrates three major functions within one web-based application. These include: (i) online psychoeducation (divided into specific thematic pathways which are further separated into individual “steps”); (ii) expert moderated social networking (via a “cafe menu”); and (iii) peer moderation. Each user can log on at their convenience, 24 hours per day. Participants will have access to the intervention for 6 months.

The features of the online psychoeducation: New users are given an introductory welcome to Altitudes which highlights ways to optimise their use of the system and how to access system help. Uses are invited to complete, at their own convenience, a series of “pathways” organised into distinct themes including self-care, understanding psychosis, early warning signs and prevention of relapse, understanding their personal strengths as a carer, managing behavioural problems in their relative, and communicating with their relative. These pathways are divided into thematically-related psychoeducation steps to maximize the usability of the material. The content of these steps, which entail narrative examples, has been specifically designed to improve carer stress, e.g., by encouraging self-care and by targeting problematic appraisals known to increase carer stress. In addition, the content of the steps have been influenced by social cognition concepts of “agency” and self-efficacy in family life. The steps and pathways entail regular prompts to users to share their reactions to material with other users through a series of “talking points”. Users’ responses populate the content of the social networking newsfeed. In addition, users can indicate their preference for material through “like” buttons, share content with others users, and can keep track of which users have completed specific pathways and which users share their specific personal strengths.

The social networking features: Users of Altitudes are encouraged to communicate with other users and with moderators through the online “cafe” where all other users are visible in the “network” page. Expert and peer moderators are also identifiable as separate classes of users within the network. Users can visit the “wall” of fellow users where posts (and comments upon posts) are displayed along with profile information and images uploaded by each user. Within each user’s home page the moderators can promote specific content, including suggested actions, which are also related to specific “steps”. A group problem solving function, entitled “talk it out” is also contained in the cafe menu which is based upon moderated problem solving from multi-family therapy research which has a well-established evidence base for its effectiveness in psychosis. Users can suggest everyday problems in caring for their relative, and the moderator invites other users to join in the problem solving “group”. The system stores previous problems and solutions, providing an easily accessible “solution wiki” to subsequent users. The social networking combined with problem solving and psychoeducation has been designed to provide social support, increase carers’ understanding of their relative’s disorder, and increase flexibility of interpersonal problem solving and communication, e.g., carers struggling with high levels of emotional over-involvement can be encouraged through the moderated network to facilitate greater independence in their relative and to increase their self-care. Where high levels of criticism of the young person are evident, psychoeducation, through the structured modules and through social networking, will be aimed at re-attributing causes of behaviour and encouraging increased self-efficacy in carers.

The role of online moderators: An expert clinical moderator trained in cognitive behavioural family therapy, together with a peer moderator (i.e., a carer with lived experience) in both Melbourne and Perth will be recruited for the duration of the trial. They will log on at daily intervals to assist with modelling and facilitating interactions. Their goal is to encourage self-care, self-efficacy and positive coping within families such as self-talk, active problem solving and positive reframing. Moderators aim to facilitate these outcomes through the provision of emotional and social support, increased recognition of strengths, and development of problem solving skills within a supportive online environment. In addition, the intervention will also incorporate the involvement of a peer moderator with lived experience of caring for a young person with early psychosis.

Usage of Altitudes will be measured by monitoring usage of the online system across the study intervention period (i.e. frequency, duration and patterns of use). This will occur through automated processes built into the platform. A number of self report measures will also be completed by participants to assess their experience of using Altitudes. Perceived competence using Altitudes will be measured by the Altitudes Perceived Competence Scale. Motivation for using Altitudes will be assessed through the Altitudes Self-Regulation Questionnaire. Users’ perception of Altitudes moderation will be assessed via the Altitudes Health Care Climate Questionnaire.

Participants attending the Altitudes workshops will also be invited to participate in focus groups to assess their experience using the online system.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The control treatment will be treatment as usual. All participating carers received a psychoeducation booklet that included information about psychosis and treatment, helpful contacts, as well as coping skills and suggestions for ways to assist and communicate with their relative. Additional carer services potentially included meetings with their relative’s case manager, psychiatrist, family peer worker, or carer consultant, as well as access to carer support groups. These differed by service. The use of services provided by the early psychosis service will be documented via a self-report survey designed especially for the current trial.

Control group

Active

Outcomes

Primary outcome [1]

Perceived stress - Perceived Stress Scale

Timepoint [1]

Baseline, 3 month and 6 month follow up

Secondary outcome [1]

Objective/chronic stress - hair cortisol

Timepoint [1]

Baseline, 6 month follow up

Secondary outcome [2]

Depression - Center for Epidemiologic Studies Depression Scale-Revised

Timepoint [2]

Baseline, 6 month follow up

Secondary outcome [3]

Self-efficacy - "Me as a Parent” Questionnaire

Timepoint [3]

Baseline, 6 month follow up

Secondary outcome [4]

Perceived social support - Medical Outcomes Study: Social Support Survey

Timepoint [4]

Baseline, 6 month follow up

Secondary outcome [5]

Coping - Ways of Coping scale

Timepoint [5]

Baseline, 6 month follow up

Secondary outcome [6]

Dynamic carer stress - Smartphone Ecological Momentary Assessment (SEMA) tool

Timepoint [6]

Baseline, 6 month follow up

Secondary outcome [7]

Loneliness - UCLA Loneliness Scale

Timepoint [7]

Baseline, 6 month follow up

Secondary outcome [8]

Strengths use - Strengths Use Scale

Timepoint [8]

Baseline, 6 month follow up

Secondary outcome [9]

Self-Compassion - Self-Compassion Scale Short Form

Timepoint [9]

Baseline, 6 month follow up

Secondary outcome [10]

Mindfulness - Mindful Attention Awareness Scale

Timepoint [10]

Baseline, 6 month follow up

Secondary outcome [11]

Satisfaction with Life - Satisfaction With Life Scale

Timepoint [11]

Baseline, 6 month follow up

Secondary outcome [12]

Substance use - Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) version 3.0

Timepoint [12]

Baseline, 6 month follow up

Secondary outcome [13]

Cost-effectiveness - AQoL 8D and Resource Use Questionnaire

Timepoint [13]

Baseline, 6 month follow up

Secondary outcome [14]

Expressed emotion - Family Questionnaire

Timepoint [14]

Baseline, 6 month follow up

Secondary outcome [15]

Impact of the illness on the family - Experience of Care-giving Inventory

Timepoint [15]

Baseline, 6 month follow up

Secondary outcome [16]

Communication and the quality of the relationship of carers and their young person - Parent- Adolescent Communication Scale

Timepoint [16]

Baseline, 6 month follow up

Secondary outcome [17]

Worry - Penn State Worry Questionnaire

Timepoint [17]

Baseline, 6 month follow up

Secondary outcome [18]

Mental Health Continuum Short Form

Timepoint [18]

Baseline, 6 month follow up

Secondary outcome [19]

Altitudes Usability Questionnaire

Timepoint [19]

6 month timepoint

Eligibility

Key inclusion criteria

Carers (parent, guardian, grandparent, spouse, sibling) of a young person who is currently receiving treatment at a participating early psychosis service. For the current trial, eligibility criteria will be intentionally inclusive, to reflect the real-world nature of the settings in which the trial will be conducted. The inclusion criteria for the young person engaged in the early psychosis service are as follows: i) aged 12 – 40 years, ii) present with symptoms or a diagnosis of a first episode of psychosis.

More than one family member will be eligible to participate from each family.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Carers who do not have sufficient English to be able to provide informed consent, complete all assessment measures, and actively engage in the Altitudes application will be excluded from the trial.

Carers who are currently engaged in legal action against their relative are also ineligible.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation occurs after the baseline assessments are completed by all family members who have consented to the study. When each member of a newly recruited family provides informed consent and completes the baseline assessment, the study RA informs the independent statistician who subsequently informs the study coordinator and investigators via an automated email of the outcome of randomization. The study coordinator informs the family.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Families are the unit of randomisation. This allows for multiple members of the one family to participate in the study and ensuring they are allocated to the same treatment arm. Families are randomised to Altitudes+TAU or to TAU alone at the ratio 1:1. We expect that participant numbers within clusters (i.e., families) are likely to vary from between 1 to 4 with a mean cluster size estimate of 1.3. An independent statistician will create the randomisation sequence, which includes permuted blocks. The block sizes and randomisation sequence are concealed from the study RA and investigators. Stratification will occur by state (Victoria; Western Australia).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Between-group differences on the primary outcome will be examined using mixed model repeated measures (MMRM) which are the preferred methods for the analysis of clinical trial data in psychiatry. Individual time-point measures can be considered to be nested within individual carers, who may also be considered to be nested within individual families. MMRM will be used for the analysis of primary and secondary outcome measures. MMRM enables analysis of hierarchically structured data (e.g., allows for violations of assumptions such as homogeneity of regression slopes across time points and effects at the family level) whilst allowing maximum flexibility in the case of missing data.

Given that families will be the unit of randomisation, it is possible that communication patterns within families will have an effect on outcomes, e.g., difference in family environments.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/08/2017

Actual

16/10/2018

Date of last participant enrolment

Anticipated

Actual

9/10/2019

Date of last data collection

Anticipated

Actual

10/07/2020

Sample size

Target

160

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University Research Fund

Address [1]

115 Victoria Parade Fitzroy
Victoria 3065

Country [1]

Australia

Primary sponsor type

University

Name

Australian Catholic University

Address

115 Victoria Parade Fitzroy
Victoria 3065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Australia Department of Health South Metropolitan Health Service HREC

Ethics committee address [1]

14 Barry Marshall Parade, Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/06/2017

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Alfred Health HREC

Ethics committee address [2]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

05/07/2017

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

University of Western Australia Human Research Ethics Committee

Ethics committee address [3]

35 Stirling Highway
Perth WA 6009
Australia

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

17/01/2018

Approval date [3]

19/01/2018

Ethics approval number [3]

RA/420/4245

Summary

Brief summary

Carers of young people with first episode psychosis endure high levels of stress and depression, and eroded social networks. Family cognitive behaviour therapy (CBT) leads to significantly improved perceived stress, but there are well-known barriers to dissemination. To address this, we have developed a novel online intervention (‘Altitudes’) that integrates social networking, expert and peer moderation, and evidence-based psychoeducation. The aim of this cluster randomised controlled trial is to evaluate the effectiveness of Altitudes relative to Treatment as Usual (TAU) in real-world clinical services in Perth and Melbourne.  We will recruit family members of 12-40 year-olds with first episode psychosis. The primary hypothesis is that carers accessing Altitudes + TAU will report significantly less perceived stress at 6 months compared with those receiving TAU only. We also predict that the Altitudes group will experience reduced objective stress, improved positive coping, self-efficacy, depression and perceived social support at follow-up.

Trial website

Trial related presentations / publications

Public notes

A rigorous safety protocol has been developed by the researchers in conjunction with experts from the computing and information systems discipline. The safety protocol is comprised of 3 levels of security including: 1) system and privacy protection, 2) online safety, and 3) clinical safety.

System and privacy protection: A range of measures are in place to help ensure the security of the website. The application is hosted on a University of Melbourne web server. The University has standard measures in place to prevent unauthorised access to the server. In addition, the web application includes measures to secure the application and database against unauthorised access. These measures conform to industry best practice as defined by the Open Web Application Security Project (www.OWASP.org).
Online safety: Privacy and online safety will be managed in accordance with the 'Online social networking' guidelines published by 'Cybersmart', a national cybersafety and cybersecurity education program managed by the Australian Communications and Media Authority (ACMA). Cybersmart is designed to meet the needs of its target audiences of young people, parents, teachers and library staff. Information about Cybersmart can be found at http://www.cybersmart.gov.au/, while the guidelines are available at http://www.acma.gov.au/.
Safe and informed orientation to the system will be a priority for the research team. A moderator will meet face-to-face or via the telephone with each East-West participant to provide them with logon details, help set up their account and orient them to the Altitudes system, including details of the terms of use. Hard copies of ‘Altitudes Terms of Use’ will be provided to users, which will be made available online and in printed form. Participants will be required to sign the hard copy as well as accepting the terms of use on entry into the system. The system also includes a "report function" which enables users at any time to indicate to the moderator a concern about any material posted by a user, including concern about potential abuse. The moderator will assess the basis of the report and respond accordingly, which can include the removal of the material and in some cases the deactivating or restriction of the user's account. In addition, users will be able to "switch off" their profile and hide all of their existing comments on the system should they become concerned about their privacy during their course of participation. The limits of the moderator to respond (e.g., in a timely manner) will also be fully explained. If participants do not comply with the guidelines for safe use of Altitudes (e.g., discriminatory comments towards other users; disclosing identifying details of the identified patient) they will be excluded from the system.
Clinical safety: It is possible that participants may post information indicative of a clinical risk in their relative, although participants will be advised that the service cannot respond to emergencies. Nonetheless, clinical risk will be monitored through manual and automated procedures. Information related to clinical risk will be screened during weekdays by moderators and during weekends by the senior researchers. This information can include: 1) posts made by participants, which disclose evidence of deterioration in mental state of the young person in the care of participants; 2) participants reports or complaints on posts made by other users; and 3) automatically detected and blocked words posted by participants in the system. Any detected increased risk will activate the Altitudes safety protocol which includes a number of potential actions. Initially, the moderator will conduct a risk assessment based upon available information, inform the research team, and advise the participant on appropriate action. In addition, the system incorporates visible emergency guidelines and contact information (i.e., on every webpage). Telephone numbers and emergency contact details, will be provided on each page of the website. 
An automated keyword system has also been built in Altitudes which will be activated each time a participant posts a contribution containing potentially offensive words. When these words are detected the contribution will be blocked and the participant will be sent an automated email explaining that the message has been blocked and if they are facing distress then they should contact the emergency contact number as soon possible or if they are not facing distress they may like to consider rephrasing their post. An automated email will also be sent to the Altitudes moderator containing the attempted post. 
In addition, a message will be available on each page providing a mobile telephone number carried by a member of the research team for any emergencies that are related specifically to the use of the Altitudes’ system (e.g., highly inappropriate use of the system).
Withdrawal criteria: Temporary or permanent withdrawal from the East West trial will be triggered by repeated inappropriate use of the system. This can include either suspension of a users' Altitudes account or restrictions regarding participation and use of Altitudes (i.e., the user is able to access therapeutic content and support from moderators, but cannot post comments or participate in existing threads within the social network). 
 
Monitoring of adverse events
System and privacy protection will be monitored by the study programmer. Online safety will be monitored by the Altitudes moderator with supervision from the senior researchers. The moderator will have the authority to respond to online reports (e.g., remove offending material from the system) and automated emails.

Clinical safety will be monitored proactively by the moderators through daily monitoring of the activity on Altitudes. In addition, information related to wellbeing of participants could be brought to the attention of the research team from two potential sources: a) the online moderators via daily monitoring of the site; and, b) the RA at an interview. 
The research team will respond according to a risk management algorithm (see Appendices, section 31), which outlines the required response to potential indicators of clinical risk in terms of the source of the information. If the online moderator becomes aware of potential indicators of risk in the online application they will conduct an initial risk assessment, make the appropriate clinical response and inform the supervisor. If the study RA becomes aware of an indicator of clinical risk they will inform their supervisor who will again respond clinically. The supervisor will assess the criteria for withdrawal and potential suspension of usage restriction to a user’s Altitudes account. The principal investigator (Professor Gleeson) will have ultimate responsibility for withdrawing participants from the study or restricting their Altitudes account. 
Reporting of adverse events
Any adverse outcomes for participants, such as exposure to potentially harmful interactions through the social networking, will be reported to the ethics committee. In the event that a participant informs the moderators of an adverse event relating to the young person in their care or of any signs of deterioration in their mental health, the Altitudes moderators will communicate with the relevant clinicians where indicated.

Contacts

Principal investigator

Name

Prof John Gleeson

Address

School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065

Country

Australia

Phone

+61 3 9953 3108

Fax

john.gleeson@acu.edu.au

Contact person for public queries

Name

John Gleeson

Address

Australian Catholic University
115 Victoria Parade
Fitzroy, VIC, Australia 3065

Country

Australia

Phone

+61 3 99533108

Fax

john.gleeson@acu.edu.au

Contact person for scientific queries

Name

John Gleeson

Address

School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065

Country

Australia

Phone

+61 3 9953 3108

Fax

john.gleeson@acu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Ethics approval was contingent on participants being able to "opt in" to having their data shared with other researchers. It is not logistically feasible for the researchers to extract a small subset of data of those consenting participants.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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