Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001059651
Ethics application status
Approved
Date submitted
23/08/2023
Date registered
3/10/2023
Date last updated
3/10/2023
Date data sharing statement initially provided
3/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A targeted digital intervention for youth with suicidal thoughts and behaviours attending outpatient care
Scientific title
Pragmatic trial of the efficacy of a targeted digital intervention for reducing suicidal ideation in youth with suicidal thoughts and behaviours attending outpatient care
Secondary ID [1] 307710 0
None
Universal Trial Number (UTN)
U1111-1281-2739
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 327269 0
Suicidal thoughts 327270 0
Suicidal behaviours 331447 0
Condition category
Condition code
Mental Health 324403 324403 0 0
Depression
Mental Health 324404 324404 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in the trial involves a 12 week intervention period, with a follow up at week 26 and 52.

Participants randomised to the intervention condition will receive access to the Moderated Online Social Therapy (MOST) platform with additional content specifically designed to target theoretical constructs of the interpersonal theory of suicide. Engagement in the MOST platform and novel content is at the user's discretion. Participants in the intervention condition will also receive a caring contact intervention via a digital postcard weekly during the 12-week intervention period.

Additionally, they will have the opportunity to participate in a fortnightly psychosocial recovery group. As well they may allow their caregiver(s) to participate in a monthly psychoeducation session.

Brief Summary of content on the MOST platform
The MOST platform has content addressing a variety of mental health issues such as depression, anxiety, social skill development. It draws on a variety of psychological principles such as cognitive behavioural therapy, self-determination theory, behavioural activation. Users complete journeys. Journeys contain tracks with specific focuses. Tracks have activities that involve psychoeducation, behavioural activation, opportunities to communicate experiences with the broader platform, opportunities to reflect on experiences and journal thoughts.

Brief summary of the novel additional content:
- the novel additional content for the Affinity trial has been developed based on the interpersonal theory of suicide and targets experiences of perceived burdensomeness, thwarted belongingness and interpersonal hopelessness
The mode of training used:
- Content is delivered via psychoeducational material, behavioural activation tasks, visually and audio guided meditations.

Strategies used to monitor adherence to the intervention:
- certain content has the capacity for the participant to contribute a response / confirm completion.
- all engagement with the MOST platform is captured as data and can be analysed to understand the way in which participants adhered to the intervention.

- the caring contact intervention involves the clinical moderator sending a singular digital comic postcard to the participant each week with text content that will express care for the participant. The caring contact post card will be sent via the MOST platform.

Details of the fortnightly psychosocial recovery group:
- what it involves:

Session 1:
Introductions, guidelines for group sessions and group rules
Psychoeducation about burdensomeness
Discussion and sharing activity
Vignette analysis and advice provision

Session 2:
Introductions, guidelines for group sessions and group rules
Psychoeducation about belongingness
Discussion and sharing activity
Vignette analysis and advice provision

Session 3:
Introductions, guidelines for group sessions and group rules,
Psychoeducation about interpersonal hopelessness
Discussion, sharing and activity.
Vignette analysis and advice provision

Session 4:
Introductions, guidelines for group sessions and group rules,
Psychoeducation about mood monitoring
Vignette analysis, and advice provision

Session 5:
Introductions, guidelines for group sessions and group rules,
Psychoeducation about interpersonal skills problem solving
Vignette analysis, roleplay, advice provision

Session 6:
Introductions, guidelines for group sessions and group rules,
Psychoeducation about emotional regulation
Vignette analysis, roleplay, and advice provision

Duration of the sessions: 1 hour
The group size: minimum group size is 2, maximum is 10
The mode of administration: over Zoom
Who will be facilitating the sessions: psychologist or social worker.
Brief description of any strategies used to monitor adherence to the intervention: session attendance checklist

Details of the monthly psychoeducation session:
What it involves, including a description of each of the procedures, activities, and/or processes used:

Session 1
Reduce shame and stigma among caregivers
Reframing and understanding suicidality in young people
Psychoeducation regarding burdensomeness and belongingness
Session 2
Psychoeducation and activities focussed on increasing emotional attunement to young person
Session 3
Changing contingencies within the home environment
Caregiver skills coaching


Duration of the sessions: 1 hour

Delivery format: minimum one attendee, no maximum attendees
The mode of administration: Zoom
Who will be facilitating the sessions, psychologist, social worker, or family therapy clinician
Description of any strategies used to monitor adherence to the intervention: Session attendance checklists
Intervention code [1] 324186 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control condition will receive treatment as usual which includes access to the standard form of MOST.

The MOST model is unique in integrating: i) peer-to-peer online social networking; ii) individually tailored interactive psychosocial interventions; and (iii) involvement of expert mental health moderators to ensure appropriate delivery and the safety of the intervention. Participants access MOST via a secure webpage.

Control group
Active

Outcomes
Primary outcome [1] 332216 0
Rate of change in suicidal thoughts when compared to control group as measured by the Suicidal Ideation Questionnaire (SIQ).
Timepoint [1] 332216 0
Baseline, Week 4, Week 8, and Week 12 post-baseline (primary endpoint), Week 26 post baseline, Week 52 post baseline.
Primary outcome [2] 336058 0
Rate of change in suicidal behaviours when compared to control group as measured by the Columbia Suicide Severity Rating Scale (C-SSRS).
Timepoint [2] 336058 0
Baseline, Week 4, Week 8, and Week 12 post-baseline (primary endpoint), Week 26 post baseline, Week 52 post baseline.
Secondary outcome [1] 412576 0
Change in symptoms of depression as measured by the Quick Inventory of Depression (QIDS), the Male Depression Risk Scale 7 Item (MDRS-7) and the Patient Health Questionnaire 4 Item (PHQ-4).
Timepoint [1] 412576 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [2] 412577 0
Change in perceived burdensomeness as measured by the Interpersonal Needs Questionnaire Short Form 10 (INQ-10)
Timepoint [2] 412577 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [3] 412578 0
Change in thwarted belongingness than control group as measured by the Interpersonal Needs Questionnaire Short Form 10 (INQ-10)
Timepoint [3] 412578 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [4] 412579 0
Change in interpersonal hopelessness as measured by the Interpersonal Hopelessness Scale (IHS).
Timepoint [4] 412579 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [5] 427059 0
Change in self hatred as assessed by the Self Hatred Scale (SHS)
Timepoint [5] 427059 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [6] 427060 0
Change in anxiety as measured by the Patient Health Questionnaire 4 (PHQ-4)
Timepoint [6] 427060 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [7] 427061 0
Change in Self Compassion will be measured by the Self Compassion Scale Short Form (SCS-SF)
Timepoint [7] 427061 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [8] 427062 0
Change in difficulty in regulating emotion will be measured by the Difficulty in Regulating Emotion Scale 18 Item (DERS-18)
Timepoint [8] 427062 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [9] 427063 0
Alliance with MOST moderators will be measured by the Working Alliance Inventory Short Form - Client version (WAI-SF-C)
Timepoint [9] 427063 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [10] 427064 0
Ease, safety accessibility and helpfulness of the Affinity intervention will be measured by the Affinity Ease, Safety, Accessibility and Helpfulness questionnaire (A-ESAH).
Timepoint [10] 427064 0
Week 12 post-baseline
Secondary outcome [11] 427065 0
Quality-adjusted life years (QALY) will be calculated by the analysis of data collected from the Assessment of Quality of Life (AQoL–4D)
Timepoint [11] 427065 0
Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.
Secondary outcome [12] 427066 0
Resource use will be measured by the Resource Utilisation Questionnaire (RUQ) as part of the economic analysis.
Timepoint [12] 427066 0
Baseline, Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Eligibility
Key inclusion criteria
(i) Age 15-25 years inclusive
(ii) Client of either headspace or the Youth Mood Clinic
(iii) At least moderate or higher depressive symptomology as measured by the Quick Inventory of Depression (QIDS)
(iv) Current or recent (within 4 weeks) suicidal thoughts or behaviours
(v) Engagement in outpatient or community-based care
(vi) Internet and smartphone or computer access
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Intellectual disability
(ii) Inability to read English
(iii) Participation in concurrent intervention or trial targeting suicidal thoughts or behavior
(iv) Unwillingness to engage in safety planning and crisis supports

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)
Central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome: The rate of change in suicidal ideation (as assessed by the Suicidal Ideation Questionnaire; SIQ) from baseline to week 12 will be analyzed using an in intention to treat approach, via linear mixed model (LMM) analysis with a restricted maximum likelihood estimator. LMM will include random intercepts for each participant. Relevant baseline outcome scores will also be included as fixed effects. SIQ changes for each treatment group will be calculated. The outcome of interest is between-group change from baseline to week 12, with p<.05, two-tailed.

Secondary outcomes: Sustained improvement in suicide ideation will be examined using LMM. Here, change over the 12-month follow-up period (weeks 26, 52) will test Affinity relative to the active control condition. Improvement in depression symptoms (assessed by the Quick Inventory of Depression Symptomatology; QIDS) and suicide attempt rates (assessed by the Columbia Suicide Severity Rating Scale; C-SSRS) will also be examined over the follow-up period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22905 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 38213 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 311984 0
Government body
Name [1] 311984 0
NHMRC
Country [1] 311984 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
35 Poplar Road, Parkville Victoria 3052
Country
Australia
Secondary sponsor category [1] 313471 0
None
Name [1] 313471 0
Address [1] 313471 0
Country [1] 313471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311407 0
The Royal Melbourne Hospital (RMH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 311407 0
300 Grattan Street, Parkville VIC 3050
Ethics committee country [1] 311407 0
Australia
Date submitted for ethics approval [1] 311407 0
31/08/2022
Approval date [1] 311407 0
25/07/2023
Ethics approval number [1] 311407 0
2022.276

Summary
Brief summary
The Affinity trial aims to assess the efficacy of an enhanced version of the moderated online social therapy (MOST) digital therapeutic social networking platform in reducing suicidal thoughts and behaviours in young people attending outpatient care. Participants randomized to the intervention condition will also have the option of participating in a fortnightly online psychosocial recovery group and to invite their caregivers to participate in caregiver online psychoeducation sessions. It is expected that the Affinity intervention condition will be faster at, and have greater maintained effects in, reducing levels of suicidal ideation than the treatment as usual condition. Effects of therapeutic mechanisms of action, as well as health economic aspects will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120986 0
A/Prof Simon Rice
Address 120986 0
Orygen, 35 Poplar Road, Parkville Victoria 3052
Country 120986 0
Australia
Phone 120986 0
+61 419 497 599
Fax 120986 0
Email 120986 0
simon.rice@orygen.org.au
Contact person for public queries
Name 120987 0
Mr Derek English
Address 120987 0
Orygen, 35 Poplar Road, Parkville Victoria 3052
Country 120987 0
Australia
Phone 120987 0
+61 437 541 890
Fax 120987 0
Email 120987 0
derek.english@orygen.org.au
Contact person for scientific queries
Name 120988 0
A/Prof Simon Rice
Address 120988 0
Orygen, 35 Poplar Road, Parkville Victoria 3052
Country 120988 0
Australia
Phone 120988 0
+61 419 497 599
Fax 120988 0
Email 120988 0
simon.rice@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication, possibility of extending end date.
Available to whom?
Only researchers who provide a methodologically sound proposal and case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
IPD meta analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator
simon.rice@orygen.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16829Informed consent form    384482-(Uploaded-23-08-2023-11-27-51)-Study-related document.docx
20092Ethical approval    384482-(Uploaded-23-08-2023-11-28-58)-Study-related document.pdf



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.