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Trial registered on ANZCTR


Registration number
ACTRN12617000370303
Ethics application status
Approved
Date submitted
20/02/2017
Date registered
10/03/2017
Date last updated
10/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of the enhanced moderated online social therapy (MOST) model within a national youth e-mental health service (eheadspace): The MOST+ project
Scientific title
Feasibility, acceptability and safety of the enhanced moderated online social therapy (MOST) model within a national youth e-mental health service (eheadspace): The MOST+ project
Secondary ID [1] 291167 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Various mental health disorders 302050 0
Condition category
Condition code
Mental Health 301683 301683 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enhanced MOST (Moderated Online Social Therapy), called MOST+

MOST+ adopts a strengths-based approach through which users are guided and prompted to identify, discuss and exercise key personal strengths within the online social environment and in real life, to foster positive mood, enhance social connectedness and self-efficacy, and build resilience. This approach is based on the positive psychology model which proposes that psychosocial interventions should aim to build strengths, meaning and purpose as well as relieve symptoms.

Materials
A self-report registration survey will be completed, primarily consisting of items administered within the registration for standard eheadspace services. Additional items screen for immediate clinical risk, request details for an emergency contact, and assess key secondary study outcomes.
All participants will have access to the MOST+ platform, called Generation. Participants are presented with a welcome letter and a video tutorial at first login after registering. Generation includes 1) user-directed strength-based activities; 2) short comics designed to guide and teach the user; 3) clinician-delivered webchat; and 4) moderated peer-to-peer social networking.
Follow-up survey includes various questionnaires (see ‘Outcomes’ section of registration).
Training of Generation moderators will utilise a training manual written specifically for this study.

Procedures
Approximately 250 young people will be progressively recruited to the intervention via a link on the eheadspace homepage over the first 4 weeks of an 8-week pilot.
The link will be active only when MOST+ clinicians are available (4pm to midnight AEDST).
A brief screen will determine eligibility. Eligible young people will be presented with details of the study procedures, and consent form. Those who screen as ineligible for MOST+ will be redirected to the eheadspace homepage. Consenting, eligible young people will be administered an online registration survey (approx. 10 minutes) prior to study enrolment.
Participants will be granted partial access (i.e., access to evidence based therapy content and clinician delivered web-chat) following registration. Full access (social networking) will be enabled once telephone contact is made to confirm age (16-25 years) and conduct induction. If i) participants indicate acute clinical risk (ie. risk of self-harm) or ii) participation in social networking is likely to interfere with management of symptoms or harm to others, full access will not be enabled until further assessment. Young people who are excluded from social networking will have access to all other features of MOST+, in addition to any additional referred services.
MOST+ clinicians will operate according to the eheadspace clinical governance framework. The clinician delivered web-chat with screened high risk MOST+ users will focus on risk assessment and management, with referral to additional services where possible and appropriate. Following implementation of the appropriate clinical response, eligibility for the social networking component of MOST+ will be determined based on the treating clinician’s assessment of ongoing safety and treatment needs.
Generation enrolment periods will be managed via an automated process. At 5 days post intervention enrolment, all participants will receive an SMS reminder to log on to MOST+ and renew their account within two days, if they wish. Participants who choose to log in and renew their account will be granted an additional week of access. This weekly opt-in process will be repeated until the participant chooses not to renew their account, or until the end of the pilot. If a participant chooses not to renew their account within two days of receiving their reminder SMS, their profile will be automatically deactivated.
User profiles and social network contributions will be hidden at account deactivation. Participants will have a 4-day grace period to reactivate their account and restore their profile information. All other user activity, including social network comments, will not be reinstated.
Follow-up assessments will be conducted online and via telephone approximately 4 days after a users’ account has deactivated. Participants will first receive an SMS link to their online follow-up survey followed by a phone call from the study RA to conduct the semi-structured feedback interview. Those participants who have not yet completed their online follow-up survey at the time of successful RA contact will be asked to complete this over the telephone. It is anticipated follow-up will take approx. 20 minutes.
Participants who maintain active enrolment across the study intervention period will complete follow-up assessments as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.

Who
Peer moderators will be trained and supported young people with a recent lived experience of mental ill health. They will be active members of the MOST+ social network to provide guidance and emotional peer-to-peer support, and foster hope and empowerment.
All clinicians working within the Generation platform will be eheadspace clinicians, who are allied health professionals and have specialist training and experience in the delivery of e-mental health support to young people in distress.

Modes of delivery
Participants can log into the online Generation platform at any time. Through a link on Generation, participants can initiate text-based interactive web chat with a clinician if there is a clinician available.

Where
Generation is available to young people living within Australia, wherever internet access is possible. eheadspace clinicians will be based at the eheadspace operation centre in Melbourne.

When & how much
Participants will be given initial access to the MOST+ intervention for one week, with the option to extend their access on a weekly basis across the study intervention period. Thus, enrolment in the intervention will range from a minimum of one week to a maximum of eight weeks. Participants will be able to reactivate an expired account at any time during the study intervention period, and this will be treated as a second episode of care.

Tailoring
Super users and clinicians are encouraged to personalise communication to suit the needs and circumstances of each participant.

Assessment of adherence
Usage of the online system will be monitored across the study intervention period. Generation clinicians and Super Users will provide guidance and encourage user directed engagement with MOST+ therapy content.
Intervention code [1] 297163 0
Behaviour
Intervention code [2] 297322 0
Treatment: Devices
Intervention code [3] 297324 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301068 0
Intervention feasibility. Assessment of intervention feasibility will involve reviewing a log of participants' level of access to the Generation platform. The log will include reasons for maintained partial access following initial intervention enrolment, as well as details of any full or partial withdrawals from the intervention.
Timepoint [1] 301068 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Primary outcome [2] 301069 0
Intervention acceptability. Acceptability will be assessed at follow-up using specially designed questions administered within a semi-structured feedback interview. Acceptability will be considered achieved if (i) participants provide above average ratings of the MOST+ platform across feedback questions and (ii) at least 60% of participants report that the MOST+ intervention provided timely, relevant and helpful support at semi-structured follow-up interview.
Timepoint [2] 301069 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Primary outcome [3] 301070 0
Intervention safety. The pilot will be considered to indicate safety of the MOST+ intervention if: (i) all participants report the online intervention to be safe via semi-structured feedback interview at follow-up; (ii) no participants experience a serious adverse event as a result of their engagement with the system during their intervention period (i.e., no participants experience a significant deterioration in mental health or self-harm in response to intervention content, as reported by the participant or determined by treating health care professionals); and (iii) there are no unlawful entries into the MOST+ system during the 8-week pilot.

Adverse event monitoring & response: System and privacy protection will be monitored by the study programmer. Online safety will be monitored proactively by the MOST+ clinicians, with supervision from the senior researchers. MOST+ clinicians will have the authority to respond to online reports (e.g., remove offending material from the system) and automated emails.

Information related to clinical safety of a participant could be brought to the attention of the research team from three potential sources: a) a MOST+ clinician via web-chat with users within the MOST+ interface; b) a MOST+ clinician via daily monitoring of user posts within the social network; and (c) a study RA via telephone interview.

The research team will respond to indications of clinical risk according to the MOST+ safety algorithm. If a MOST+ clinician becomes aware of potential indicators of risk in a participant they will conduct an initial risk assessment, make the appropriate clinical response and inform their supervisor. If a study RA becomes aware of an indicator of clinical risk they will inform their supervisor, who will initiate a prompt risk assessment and clinical response. All indications of clinical risk will be communicated to the coordinating investigators, who will determine whether study withdrawal criteria are met in consultation with the relevant members of the clinical and research team.
Timepoint [3] 301070 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [1] 331649 0
Psychological distress will be assessed by the Kessler Psychological Distress Scale (K10; Kessler et al., 2002).
Timepoint [1] 331649 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [2] 331652 0
Functional impairment will be assessed by a single item included in the eheadspace MDS, which assesses number of days of impaired role function over the preceding two weeks.
Timepoint [2] 331652 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [3] 331653 0
Mental well-being will be assessed by three items included in the eheadspace MDS, which were selected from the 14-item Warwick-Edinburgh Mental Well-being Scale (WEMWBS; Tennant et al., 2007).
Timepoint [3] 331653 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [4] 331655 0
Satisfaction with life, assessed using the Satisfaction with Life Scale (Diener et al., 1985).
Timepoint [4] 331655 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [5] 331656 0
Strengths use will be assessed by the Strengths Use and Knowledge Scales (SUKS; Govindji & Lingley, 2007; Wood et al., 2010). Included as an exploratory measure.
Timepoint [5] 331656 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [6] 331657 0
Social support and isolation will be assessed by two three items selected from the UCLA Loneliness Scale (UCLA-LS; Russell, 1996). Items were selected by the research team based on high factor loadings and face validity (Hughes, Waite, Hawkley & Cacioppo, 2004). The Friendship Scale (6-items; Hawthorne, 2006) will also assess social support and isolation.
Timepoint [6] 331657 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [7] 331691 0
Depression will be assessed by the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)
Timepoint [7] 331691 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [8] 331692 0
Mindfulness will be assessed by the Freiburg Mindfulness Inventory (FMI; Walach et al., 2006). Included as an exploratory measure.
Timepoint [8] 331692 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [9] 331693 0
Perceived Stress will be assessed by the Perceived Stress Scale (PSS; Cohen et al., 1983).
Timepoint [9] 331693 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [10] 331694 0
Components of Self-Determination (autonomy, relatedness, competence) will be assessed by the Basic Psychological Needs Questionnaire (BPN; 21-items; Deci et al., 2001). Included as an exploratory measure.
Timepoint [10] 331694 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [11] 332198 0
Usage of MOST+. This composite measure will be measured by monitoring usage o f the online system across the study intervention period (i.e. frequency, duration and patterns of use, as well as wait times for clinician delivered web-chat).
Timepoint [11] 332198 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [12] 332199 0
MOST+ usability will be assessed by the Website Analysis and Measurement Inventory (WAMMI; Kirakowski & Cierlik, 1998).
Timepoint [12] 332199 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.
Secondary outcome [13] 332200 0
User experience (composite outcome). This will include a number of additional quantitative and qualitative intervention feedback items, and will be administered within a semi-structured telephone interview format at follow-up to gain a detailed understanding of areas for improvement within the system. The interview questions are based on the User Experience (UX) approach as described by Bargas-Avila and Hornbaek (2011). Interviews will allow the study RA to explore six themes: overall impressions of MOST+, patterns of system use, feedback on specific aspects (e.g., psychosocial interventions), web-chat and moderation, interactions with other MOST+ users (if relevant), and suggestions for system improvements.
Timepoint [13] 332200 0
During follow-up assessment, occurring approx. 4 days after initial account deactivation (i.e., 4 days after a user has opted not to renew their account for an additional week) or, for those participants who maintain active enrolment across the study intervention period, as soon as possible following conclusion of the pilot. In order to understand the likely real world usage levels of this intervention, the number of users will not be capped. Therefore, it is difficult to predict the total duration of follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria will reflect the ‘real world’ clinical characteristics of young people accessing e-mental health support, that is (i) help-seeking young people experiencing psychological distress, (ii) age of 16 to 25 years inclusive, and (iii) ability to give informed consent and comply with study procedures.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for full access to Generation (i.e., additional access to moderated peer-to-peer social networking) include: (i) acute risk of self-harm requiring urgent intervention (i.e., suicidal ideation with a current plan and intent to enact this plan); and (ii) participation in the Generation social network is likely to interfere with appropriate clinical management of psychiatric symptoms (e.g., psychosis or bipolar disorder) or risk of harm to self or others. These criteria will be reviewed on an ongoing basis by Generation clinicians.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Frequency, duration and patterns of use of MOST+ will be tracked in real-time. Up-to-date charts will be visible on demand to MOST+ staff via the moderator interface of the online platform. Available data will include levels of engagement with the interactive therapy modules, number of posts to the social network, and usage of web-chat with an eheadspace clinician. This data will be aggregated into simple descriptive statistics in order to characterise participants’ use of the intervention. In addition, overall rates of MOST+ participation and aggregated data from the user feedback questionnaire will be compared to the a priori acceptability, safety and acceptability criteria in order to determine success of the pilot. Supplementary paired samples t-tests will be conducted to assess pre to post-intervention changes to key psychosocial outcomes (i.e., psychological distress, functional impairment, satisfaction with life, mental wellbeing, social support and isolation, and strengths use and knowledge).

Sample size justification: The majority of young people who access eheadspace make use of the service on one occasion only, and a primary objective of MOST+ is to facilitate responsive and effective intervention within this short window. To mirror likely real world implementation of the MOST+ model, we will also be recruiting young people to the online intervention regardless of whether they can be contacted via telephone within the first week of study enrolment. While follow-up periods will be tailored to participants’ initial period of intervention engagement, it is likely to be challenging to retain participants who have engaged only briefly and/or were unable to be contacted via telephone at enrolment. A sample size of approximately 250 participants will therefore be necessary both to provide an adequate buffer against attrition during the study, and to ensure that there is a sufficient number of active users of MOST+ for the social networking aspect of the intervention to function effectively throughout the 8-week pilot.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295610 0
Other Collaborative groups
Name [1] 295610 0
Young and Well Cooperative Research Centre (2015-2016)
Country [1] 295610 0
Australia
Primary sponsor type
Other
Name
Orygen the National Centre of Excellence in Youth Mental Health
Address
35 Poplar Rd
Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 294449 0
Other
Name [1] 294449 0
Headspace National Office
Address [1] 294449 0
Latrobe St, Melbourne, Victoria, 3000.
Country [1] 294449 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296928 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 296928 0
Ethics committee country [1] 296928 0
Australia
Date submitted for ethics approval [1] 296928 0
27/01/2016
Approval date [1] 296928 0
17/03/2016
Ethics approval number [1] 296928 0
1545798

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

Contacts
Principal investigator
Name 72458 0
A/Prof Mario Alvarez-Jimenez
Address 72458 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked Bag 10, Parkville, VIC 3052, Australia
Country 72458 0
Australia
Phone 72458 0
+61 3 9342 2980
Fax 72458 0
Email 72458 0
[email protected]
Contact person for public queries
Name 72459 0
Mario Alvarez-Jimenez
Address 72459 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked Bag 10, Parkville, VIC 3052, Australia
Country 72459 0
Australia
Phone 72459 0
+61 3 9342 2980
Fax 72459 0
Email 72459 0
[email protected]
Contact person for scientific queries
Name 72460 0
Mario Alvarez-Jimenez
Address 72460 0
Orygen, The National Centre of Excellence in Youth Mental Health, Locked Bag 10, Parkville, VIC 3052, Australia
Country 72460 0
Australia
Phone 72460 0
+61 3 9342 2980
Fax 72460 0
Email 72460 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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