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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]

None

Universal Trial Number (UTN)

U1111-1281-2739

Trial acronym

Linked study record

Health condition

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

Depression

Suicidal thoughts

Suicidal behaviours

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

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]

Rate of change in suicidal thoughts when compared to control group as measured by the Suicidal Ideation Questionnaire (SIQ).

Timepoint [1]

Baseline, Week 4, Week 8, and Week 12 post-baseline (primary endpoint), Week 26 post baseline, Week 52 post baseline.

Primary outcome [2]

Rate of change in suicidal behaviours when compared to control group as measured by the Columbia Suicide Severity Rating Scale (C-SSRS).

Timepoint [2]

Baseline, Week 4, Week 8, and Week 12 post-baseline (primary endpoint), Week 26 post baseline, Week 52 post baseline.

Secondary outcome [1]

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]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [2]

Change in perceived burdensomeness as measured by the Interpersonal Needs Questionnaire Short Form 10 (INQ-10)

Timepoint [2]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [3]

Change in thwarted belongingness than control group as measured by the Interpersonal Needs Questionnaire Short Form 10 (INQ-10)

Timepoint [3]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [4]

Change in interpersonal hopelessness as measured by the Interpersonal Hopelessness Scale (IHS).

Timepoint [4]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [5]

Change in self hatred as assessed by the Self Hatred Scale (SHS)

Timepoint [5]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [6]

Change in anxiety as measured by the Patient Health Questionnaire 4 (PHQ-4)

Timepoint [6]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [7]

Change in Self Compassion will be measured by the Self Compassion Scale Short Form (SCS-SF)

Timepoint [7]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [8]

Change in difficulty in regulating emotion will be measured by the Difficulty in Regulating Emotion Scale 18 Item (DERS-18)

Timepoint [8]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [9]

Alliance with MOST moderators will be measured by the Working Alliance Inventory Short Form - Client version (WAI-SF-C)

Timepoint [9]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [10]

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]

Week 12 post-baseline

Secondary outcome [11]

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]

Baseline, Week 4, Week 8, and Week 12 post-baseline, Week 26 post baseline, Week 52 post baseline.

Secondary outcome [12]

Resource use will be measured by the Resource Utilisation Questionnaire (RUQ) as part of the economic analysis.

Timepoint [12]

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?

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]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

414 La Trobe Street, Melbourne, VIC, 3000

Country [1]

Australia

Primary sponsor type

Other

Name

Orygen

Address

35 Poplar Road, Parkville Victoria 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Melbourne Hospital (RMH) Human Research Ethics Committee (HREC)

Ethics committee address [1]

300 Grattan Street, Parkville VIC 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2022

Approval date [1]

25/07/2023

Ethics approval number [1]

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

A/Prof Simon Rice

Address

Orygen, 35 Poplar Road, Parkville Victoria 3052

Country

Australia

Phone

+61 419 497 599

Fax

[email protected]

Contact person for public queries

Name

Derek English

Address

Orygen, 35 Poplar Road, Parkville Victoria 3052

Country

Australia

Phone

+61 437 541 890

Fax

[email protected]

Contact person for scientific queries

Name

Simon Rice

Address

Orygen, 35 Poplar Road, Parkville Victoria 3052

Country

Australia

Phone

+61 419 497 599

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?

• To any type of analyses. Assessed on a case-by-case basis

When can requests for individual participant data be made (start and end dates)?

From:
Data are currently embargoed. They will be available after the main results have been published for an indefinite time.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZCTRN number in the catalogue to find datasets associated with this trial.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Current supporting documents:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16829	Informed consent form					Study-related document.docx
20092	Ethical approval					Study-related document.pdf

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16829	Informed consent form					2022.276_RMH82198_PICF_Community_Version 1.0_040724_Clean.docx
20092	Ethical approval					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.

Trial Review

Documents added manually

Documents added automatically