Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001001987
Ethics application status
Approved
Date submitted
22/06/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of integrated online and face-to-face support for complex youth mental health disorders: Piloting of eOrygen.MOST
Scientific title
Safety, feasibility and acceptability of an integrated face-to-face and virtual clinic for treatment of complex youth mental health disorders : Piloting of eOrygen.MOST
Secondary ID [1] 300918 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First episode psychosis 317136 0
Borderline personality disorder 317137 0
Condition category
Condition code
Mental Health 315291 315291 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot tests a model of care wherein young people accessing specialist treatment for mental illness have access to a purpose-built online platform to use alongside regular face-to-face clinical appointments.
The online platform takes the form of Moderated Online Social Therapy (MOST), which includes:
1) 'Tracks' are discrete and brief comic-based therapy modules designed to present evidence-based therapy content in an engaging and interactive format, and focus on a specific topic (e.g. rumination, mindfulness, motivation). Interactive features include options to write personal reflections (visible to all users) and notes (not visible to other users) on certain activities within tracks, rate helpfulness of content, and save content to a personal ‘toolkit’.
2) ‘Guided Therapy Journeys’, which are collections of Tracks that can be completed in order and focus: on a) Depression; b) Anxiety; c) Social anxiety; and 4) Social Functioning.
2) 'Activities': Behavioural prompts to encourage application of therapy content (e.g. mindfulness, self-compassion) and utilise personal strengths in real-life scenarios. Most activities can be completed ‘offline’, though users may choose to integrate the social network (for example, asking a question in the social network to utilise strength of courage, or to overcome social anxiety).
3) Online social network ('The Community Newsfeed’) where users and peer workers can post text, pictures and video, comment on posts, and react to posts/comments using pre-set options (e.g. “Thinking of you”; “High five”)
4) Problem-solving forum ('Talk it Out') - designed to promote social self-efficacy and interpersonal problem solving - where users can suggest issues (e.g. how to deal with low self esteem) and discuss these in a moderated forum informed by evidence-based problem solving framework.
5) Web chat function where users can communicate with peer workers and their face-to-face clinician. Clinicians can recommend therapy content in chat and organise online check-ins between face-to-face sessions as needed.
Each guided therapy journey includes 6-8 tracks. Tracks consist of 4-11 pages presenting specific therapy content (including activities, comics and written information) which each take a few minutes to complete. In total, a guided therapy journey takes 8-10 hours to complete.
The eOrygen.MOST online platform is moderated by peer workers and mental health clinicians.
Participants will have access to eOrygen.MOST for 3 months, during which time they can access the intervention as often as desired. It is at each user’s discretion how often they use the online platform, and which feature(s) they access when they log on, though their face-to-face clinician may recommend logging on at certain times/frequencies.
All participants will complete an onboarding questionnaire to assess key strengths and presenting concerns. Based on responses, participants will be recommended a relevant therapy journey. Participants can also search for relevant therapy content using an explore function. Case managers can tailor a user’s pathway (e.g. re-order tracks or change to a different pathway).
Intervention code [1] 317407 0
Treatment: Other
Intervention code [2] 318182 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323573 0
Intervention acceptability as assessed by a combination of eOrygen.MOST usage data and responses to a feedback questionnaire designed for this study (composite outcome):
1) Proportion of participants who log-on fortnightly during the intervention period;
2) Proportion of participants who rate eOrygen.MOST as "helpful" and "easy to use" via feedback questionnaire;
3) Proportion of participants who report that they would recommend eOrygen.MOST to others via feedback questionnaire;
Timepoint [1] 323573 0
3 months after enrolment in eOrygen.MOST intervention.
Primary outcome [2] 323575 0
Intervention safety as assessed by number of serious adverse event assessed as resulting from their engagement with eOrygen.MOST. Causality and severity will be assessed by a study doctor. The pilot will be considered to indicate safety of eOrygen.MOST if no young people experience a serious adverse event as a result of their engagement with the system during their 3-month intervention period.
The online platform will be closely monitored for any indications of adverse events (e.g. in social network comments). Treating clinicians will be asked to report any adverse events (including suicide attempt and serious self-harm) to the research team. Participants who discontinue from the study will be asked about the presence of any adverse events. Adverse events may also be identified through spontaneous reporting during communication with research team (e.g. baseline phone assessment).
Timepoint [2] 323575 0
End of study (i.e. once all participants have completed the follow-up assessment 3 months after their enrolment in eOrygen.MOST intervention).
Primary outcome [3] 323578 0
Feasibility as assessed by number of participants recruited compared to target, and participant refusal rate..
Timepoint [3] 323578 0
End of recruitment period.
Secondary outcome [1] 382256 0
Social and occupational functioning as assessed by clinician rating of the the Social and Occupational Functioning Assessment Scale (SOFAS).
Timepoint [1] 382256 0
Baseline and 3 months post intervention enrolment
Secondary outcome [2] 382257 0
Therapeutic alliance between participant and their treating clinician, as assessed using the Working Alliance Inventory - Short Revised (Therapist version), completed by the treating clinician who referred the participant to the pilot study.
Timepoint [2] 382257 0
Baseline and 3 months after intervention enrolment.
Secondary outcome [3] 382258 0
Service engagement as assessed using 10 of the 15 items in the Service Engagement Scale (4 items on pharmacological treatment adherence excluded; 10 remaining items assess availability, collaboration, and help-seeking), rated by treating clinician.
Timepoint [3] 382258 0
Baseline and 3 months after intervention enrolment.
Secondary outcome [4] 382264 0
Severity of depression represented by self-reported scores on the Patient Health Questionnaire 9 (PHQ-9).
Timepoint [4] 382264 0
Baseline and 3 months after intervention enrolment
Secondary outcome [5] 382265 0
Borderline Personality Disorder symptomatology as assessed using The Borderline Severity List (BSL-23)
Timepoint [5] 382265 0
Baseline and 3 months after intervention enrolment
Secondary outcome [6] 382266 0
Psychological wellbeing as assessed using the Flourishing Scale, which includes items on feelings of competence, purpose in life, meaning and positive relationships.
Timepoint [6] 382266 0
Baseline and 3 months after intervention enrolment
Secondary outcome [7] 382267 0
Satisfaction of basic psychological needs (competence, autonomy and relatedness) as assessed using the Basic Psychological Needs Satisfaction Questionnaire.
Timepoint [7] 382267 0
Baseline and 3 months after intervention enrolment
Secondary outcome [8] 382268 0
Loneliness, as assessed using the UCLA Loneliness Scale (Version 3).
Timepoint [8] 382268 0
Baseline and 3 months after intervention enrolment
Secondary outcome [9] 382269 0
Perceived social isolation, as assessed using The Friendship Scale.
Timepoint [9] 382269 0
Baseline and 3 months after intervention enrolment
Secondary outcome [10] 382270 0
Social anxiety as assessed using the Social Interaction Anxiety Scale.
Timepoint [10] 382270 0
Baseline and 3 months after intervention enrolment
Secondary outcome [11] 382271 0
Stress, as assessed using the Perceived Stress Scale.
Timepoint [11] 382271 0
Baseline and 3 months after intervention enrolment
Secondary outcome [12] 382272 0
Psychological distress as assessed using The Kessler Psychological Distress Scale
Timepoint [12] 382272 0
Baseline and 3 months after intervention enrolment
Secondary outcome [13] 382273 0
Employment status, as assessed by self-report:
Are you currently employed? [Yes / No]
If yes, are you employed: [full-time / part-time / casually]
If no, are you [not in the labour force (e.g. home duties, not working while at school) / looking for full-time work / looking for part-time work / looking for casual work]?
Timepoint [13] 382273 0
Baseline and 3 months after intervention enrolment
Secondary outcome [14] 382276 0
Positive symptoms of psychosis, assessed using items 9 (suspiciousness), 10 (hallucinations) and 11 (unusual thought content) of The Brief Psychiatric Rating Scale (BPRS).
Timepoint [14] 382276 0
Baseline and 3 months after intervention enrolment.
Secondary outcome [15] 382280 0
Momentary positive and negative affect, anxiety, sadness and loneliness will be measured in real time using Ecological Momentary Assessment (EMA), via a brief survey designed specifically for this study. Surveys will be delivered to users' smartphone once per day, continuously over the 3 month intervention period. Participants can choose to opt-in to this component of the study.
Timepoint [15] 382280 0
Daily across the 3 month intervention period.
Secondary outcome [16] 385122 0
[Primary outcome] Intervention safety as assessed by tracking the security of the online system, specifically the number of unlawful entries into the eOrygen.MOST system during the pilot. The pilot will be considered to indicate safety of eOrygen.MOST if there are no unlawful entries into the eOrygen.MOST system during the pilot. Unlawful entries will be assessed using website usage data and automatically generated notifications sent to the system's security expert after five failed attempts to login from the same IP address (identifying potentially fraudulent login attempts).
Timepoint [16] 385122 0
End of study (i.e. once all participants have completed the follow-up assessment 3 months after their enrolment in eOrygen.MOST intervention).
Secondary outcome [17] 385123 0
[Primary outcome] Intervention safety as assessed by proportion of young people and clinicians who report eOrygen.MOST to be safe via the feedback questionnaire designed for this study. The pilot will be considered to indicate safety of eOrygen.MOST if at least 95% of young people and clinicians report it to be safe via feedback questionnaire at follow-up.
Timepoint [17] 385123 0
End of study (i.e. once all participants have completed the follow-up assessment 3 months after their enrolment in eOrygen.MOST intervention). Feedback questionnaires will be completed at the 3-month follow-up assessment.
Secondary outcome [18] 385124 0
(Primary outcome] Intervention safety as assessed by patterns of clinician and social outcome measures over the course of the study. The pilot will be considered to indicate safety of eOrygen.MOST if clinical and social measures (measures of depression, Borderline Personality Disorder, therapeutic alliance, psychological wellbeing, self-determination, loneliness, friendship, social anxiety, stress, psychological distress, psychotic symptoms) do not show a worsening pattern over the course of the study.
Timepoint [18] 385124 0
End of study (i.e. once all participants have completed the follow-up assessment 3 months after their enrolment in eOrygen.MOST intervention).
Secondary outcome [19] 385125 0
Therapeutic alliance between participant and their treating clinician, as assessed using the Working Alliance Inventory - Short Revised (Client version), completed by the participant.
Timepoint [19] 385125 0
Baseline and 3 months after intervention enrolment.

Eligibility
Key inclusion criteria
1. 16 to 27 years of age (inclusive);
2. Currently receiving treatment at Orygen with the Early Psychosis Prevention and Intervention (EPPIC) Clinic or Helping Young People Early (HYPE) Clinic, or receiving specialist mental health treatment at one of 3 participating community health services in peri-urban regions of North Western Melbourne, Australia.
3. Ability and willingness to nominate an emergency contact person, such as a close family member, who is aged 18 years or older.
4. Evidence of treatment response or reasonable remission, as judged by the treating clinician, resulting in the clinician believing that inclusion in the research project is unlikely to result in harm to the young person or other users.
Minimum age
16 Years
Maximum age
27 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intellectual disability that interferes with the likelihood of the participant receiving benefit from participation as judged by the treating clinician;
2. Inability to converse in, or read English. English does not have to be the young person’s primary language;
3. Poorly engaged in face-to-face treatment (i.e., irregular attendance at scheduled case management or medical review sessions, operationalised as less than 2 sessions attended in the past 6-weeks despite attempts to schedule appointments) or those approaching discharge (i.e., within approximately 8-12-weeks).
4. High degree of hostility and impulsivity, as judged by the treating clinician, resulting in the clinician believing that inclusion in the research project may result in harm to the young person or other users (i.e. through interactions in the social network).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Recruitment targets for each recruiting clinic are based on recommendation that a pilot study have a sample size of approximately 10% of the sample size projected for the larger parent study. The sample size was informed by power analyses for two recent RCTs utilising Moderated Online Social Therapy, conducted by our team, which both required 192 participants to detect effects at 90% power. Clinical staff at each site were consulted regarding number of clients and feasible recruitment rates.

Frequency, duration and patterns of use will be tracked in real time and analysed using descriptive statistics at the conclusion of the study.
Ecological Momentary Sampling reports of momentary positive and negative affect, anxiety, sadness and loneliness will be analysed using N=1 and/or multilevel time-series analyses to examine patterns of change across the 3-month intervention
within-subject analyses (paired samples t-tests) used to examine change to continuous variables between baseline and 3-month months post intervention enrolment.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2020
Date of last participant enrolment
Anticipated
9/10/2020
Actual
Date of last data collection
Anticipated
15/01/2021
Actual
Sample size
Target
160
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 30098 0
3052 - Parkville
Recruitment postcode(s) [2] 30099 0
3434 - Romsey
Recruitment postcode(s) [3] 30100 0
3338 - Melton South
Recruitment postcode(s) [4] 30101 0
3429 - Sunbury
Recruitment postcode(s) [5] 30102 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 305364 0
Charities/Societies/Foundations
Name [1] 305364 0
Telstra Foundation
Country [1] 305364 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
35 Poplar Rd
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 305741 0
Hospital
Name [1] 305741 0
Melbourne Health
Address [1] 305741 0
300 Grattan Street, Parkville VIC 3050
Country [1] 305741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305697 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305697 0
Ethics committee country [1] 305697 0
Australia
Date submitted for ethics approval [1] 305697 0
28/05/2019
Approval date [1] 305697 0
29/08/2019
Ethics approval number [1] 305697 0
HREC/49492/MH-2019

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

Contacts
Principal investigator
Name 101266 0
Prof Mario Alvarez-Jimenez
Address 101266 0
Orygen
35 Poplar Rd
Parkville
VIC 3052
Country 101266 0
Australia
Phone 101266 0
+61 401 772 668
Fax 101266 0
Email 101266 0
[email protected]
Contact person for public queries
Name 101267 0
Daniela Cagliarini
Address 101267 0
Orygen
35 Poplar Rd
Parkville
VIC 3052
Country 101267 0
Australia
Phone 101267 0
+61 408 607 919
Fax 101267 0
Email 101267 0
[email protected]
Contact person for scientific queries
Name 101268 0
Daniela Cagliarini
Address 101268 0
Orygen
35 Poplar Rd
Parkville
VIC 3052
Country 101268 0
Australia
Phone 101268 0
+61 408 607 919
Fax 101268 0
Email 101268 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


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.