Trial Review

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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] 292105 0
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 303523 0
Objective Stress 303524 0
Depression 329351 0
Substance use 329352 0
Condition category
Condition code
Mental Health 302934 302934 0 0
Other mental health disorders
Mental Health 302935 302935 0 0
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] 298246 0
Treatment: Other
Intervention code [2] 298247 0
Lifestyle
Intervention code [3] 298248 0
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] 302332 0
Perceived stress - Perceived Stress Scale
Timepoint [1] 302332 0
Baseline, 3 month and 6 month follow up
Secondary outcome [1] 335511 0
Objective/chronic stress - hair cortisol
Timepoint [1] 335511 0
Baseline, 6 month follow up
Secondary outcome [2] 335512 0
Depression - Center for Epidemiologic Studies Depression Scale-Revised
Timepoint [2] 335512 0
Baseline, 6 month follow up
Secondary outcome [3] 335513 0
Self-efficacy - "Me as a Parent” Questionnaire
Timepoint [3] 335513 0
Baseline, 6 month follow up
Secondary outcome [4] 335514 0
Perceived social support - Medical Outcomes Study: Social Support Survey
Timepoint [4] 335514 0
Baseline, 6 month follow up
Secondary outcome [5] 335515 0
Coping - Ways of Coping scale
Timepoint [5] 335515 0
Baseline, 6 month follow up
Secondary outcome [6] 335516 0
Dynamic carer stress - Smartphone Ecological Momentary Assessment (SEMA) tool
Timepoint [6] 335516 0
Baseline, 6 month follow up
Secondary outcome [7] 335517 0
Loneliness - UCLA Loneliness Scale
Timepoint [7] 335517 0
Baseline, 6 month follow up
Secondary outcome [8] 335518 0
Strengths use - Strengths Use Scale
Timepoint [8] 335518 0
Baseline, 6 month follow up
Secondary outcome [9] 335519 0
Self-Compassion - Self-Compassion Scale Short Form
Timepoint [9] 335519 0
Baseline, 6 month follow up
Secondary outcome [10] 335520 0
Mindfulness - Mindful Attention Awareness Scale
Timepoint [10] 335520 0
Baseline, 6 month follow up
Secondary outcome [11] 335521 0
Satisfaction with Life - Satisfaction With Life Scale
Timepoint [11] 335521 0
Baseline, 6 month follow up
Secondary outcome [12] 335522 0
Substance use - Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) version 3.0
Timepoint [12] 335522 0
Baseline, 6 month follow up
Secondary outcome [13] 335523 0
Cost-effectiveness - AQoL 8D and Resource Use Questionnaire
Timepoint [13] 335523 0
Baseline, 6 month follow up
Secondary outcome [14] 335524 0
Expressed emotion - Family Questionnaire
Timepoint [14] 335524 0
Baseline, 6 month follow up
Secondary outcome [15] 335525 0
Impact of the illness on the family - Experience of Care-giving Inventory
Timepoint [15] 335525 0
Baseline, 6 month follow up
Secondary outcome [16] 335526 0
Communication and the quality of the relationship of carers and their young person - Parent- Adolescent Communication Scale
Timepoint [16] 335526 0
Baseline, 6 month follow up
Secondary outcome [17] 335527 0
Worry - Penn State Worry Questionnaire
Timepoint [17] 335527 0
Baseline, 6 month follow up
Secondary outcome [18] 419581 0
Mental Health Continuum Short Form
Timepoint [18] 419581 0
Baseline, 6 month follow up
Secondary outcome [19] 419582 0
Altitudes Usability Questionnaire
Timepoint [19] 419582 0
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?
No
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
86
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 296636 0
University
Name [1] 296636 0
Australian Catholic University Research Fund
Country [1] 296636 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
115 Victoria Parade Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 295598 0
None
Name [1] 295598 0
Address [1] 295598 0
Country [1] 295598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297867 0
Western Australia Department of Health South Metropolitan Health Service HREC
Ethics committee address [1] 297867 0
Ethics committee country [1] 297867 0
Australia
Date submitted for ethics approval [1] 297867 0
13/06/2017
Approval date [1] 297867 0
Ethics approval number [1] 297867 0
Ethics committee name [2] 297869 0
Alfred Health HREC
Ethics committee address [2] 297869 0
Ethics committee country [2] 297869 0
Australia
Date submitted for ethics approval [2] 297869 0
05/07/2017
Approval date [2] 297869 0
Ethics approval number [2] 297869 0
Ethics committee name [3] 312614 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [3] 312614 0
Ethics committee country [3] 312614 0
Australia
Date submitted for ethics approval [3] 312614 0
17/01/2018
Approval date [3] 312614 0
19/01/2018
Ethics approval number [3] 312614 0
RA/420/4245

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

Contacts
Principal investigator
Name 75318 0
Prof John Gleeson
Address 75318 0
School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065
Country 75318 0
Australia
Phone 75318 0
+61 3 9953 3108
Fax 75318 0
Email 75318 0
[email protected]
Contact person for public queries
Name 75319 0
John Gleeson
Address 75319 0
Australian Catholic University
115 Victoria Parade
Fitzroy, VIC, Australia 3065
Country 75319 0
Australia
Phone 75319 0
+61 3 99533108
Fax 75319 0
Email 75319 0
[email protected]
Contact person for scientific queries
Name 75320 0
John Gleeson
Address 75320 0
School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065
Country 75320 0
Australia
Phone 75320 0
+61 3 9953 3108
Fax 75320 0
Email 75320 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
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

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

Documents added automatically
No additional documents have been identified.