Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000053921
Ethics application status
Approved
Date submitted
18/12/2019
Date registered
23/01/2020
Date last updated
28/06/2021
Date data sharing statement initially provided
23/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of a text-message based, brief intervention after hospitalisation for self-harm, a suicide attempt or suicidal thoughts.
Scientific title
An optimisation trial of an SMS-based, brief intervention after hospitalisation for self-harm, a suicide attempt, or suicidal ideation, targeting proximal risk factors for self-harm and suicide.
Secondary ID [1] 299062 0
Nil known
Universal Trial Number (UTN)
U1111-1236-0301
Trial acronym
RAFT (Reconnecting AFTer Discharge) - Optimisation Study
Linked study record
ACTRN12616000266460: This record was a small-scale, feasibility trial of the RAFT intervention that preceded the current trial.

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 314089 0
Self harm 314090 0
Suicide attempt 314091 0
Condition category
Condition code
Mental Health 312466 312466 0 0
Suicide
Public Health 314091 314091 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RAFT is an SMS-based intervention for people discharged from hospital for self-harm, suicidal ideation, or a suicide attempt. RAFT sends a series of ‘caring contact’ text messages with links to online therapeutic content that targets proximal risk factors for self-harm and suicide, specifically: distressing thoughts, safety planning, emotional regulation, suicidal thoughts, interpersonal relationships, and alcohol consumption. The therapeutic content was developed with input from lived experience representatives and clinical experts and is designed to be ‘low intensity’. It provides suggestions for distraction techniques, safety planning templates, information on mindfulness, and a number of case studies that challenge unhelpful thoughts and behaviours in line with cognitive behavioural therapy.

This optimisation trial will assess the benefits of receiving links to the RAFT therapeutic content relative to just receiving SMS ‘caring contact’ messages. The ‘caring contact’ text messages express the hope that the individual is doing well and invites them to reconnect with services if needed. Participants who receive links to the online resources are free to engage with them as little or as often as they wish. This trial will also assess whether providing online information to a nominated support person is beneficial.

Participants will be randomised between two arms of the study: (a) a waitlist control group who will receive treatment as usual (TAU), and (b) an intervention using a 2x2 factorial design. Participants in the intervention group will be randomised between two factors: (a) participant receiving text messages Vs participant receiving text messages with links to online content, and (b) participant receiving messages Vs participant and nominated support person receiving messages.

Participants in an intervention group will receive an automated text message at baseline, day 2, day 7, day 14, day 21 and day 28. Our IT system will collect information on which therapeutic content links are accessed and which online pages are viewed. Self-report data on recent self-harm, suicidal ideation, distress and functioning and recovery will be collected at baseline, at 5 weeks, and at 3 months. Data on repeat hospital presentations will be obtained from hospital records.
Intervention code [1] 315331 0
Treatment: Other
Intervention code [2] 315332 0
Behaviour
Comparator / control treatment
The wait list control group will receive treatment as usual i.e. they will receive whatever services/followup are offered by their treating hospital other than the RAFT intervention.

Participants in the waitlist group will receive a text message at baseline, 5 weeks and 3 months with a link to complete the study questionnaires. After completion of the 3 month questionnaires they will receive a text message with a link to all the RAFT online therapeutic content.
Control group
Active

Outcomes
Primary outcome [1] 321109 0
Suicidal ideation as measured by the Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [1] 321109 0
Baseline; 5 weeks; 3 months (primary endpoint).
Secondary outcome [1] 374023 0
Repeat hospital presentations for self-harm, suicidal ideation or a suicide attempt. This is a composite outcome. Staff at each recruitment site will conduct an audit of Emergency Department records at their hospital. We will assess: number of presentations, date of presentations, reason for presentation, whether they were admitted, and to which department/ward they were admitted.
Timepoint [1] 374023 0
12 months post-enrolment.
Secondary outcome [2] 374024 0
Self-reported episodes of self-harm via online questionnaire. The questionnaire (designed for this study) includes 3 items; frequency of life-time self-harm, frequency of recent self-harm, and frequency of recent suicide attempts.
Timepoint [2] 374024 0
Baseline; 5 weeks; 3 months.
Secondary outcome [3] 374025 0
Psychological distress as measured by the Distress Questionnaire-5 (DQ5).
Timepoint [3] 374025 0
Baseline; 5 weeks; 3 months.
Secondary outcome [4] 374027 0
Psychosocial functioning as measured by the Recovery and Functioning Scale (RFS).
Timepoint [4] 374027 0
Baseline; 5 weeks; 3 months.

Eligibility
Key inclusion criteria
Individuals are eligible to join the study if they:
- Are currently aged between 16-65 years old.
- Presented at a hospital within the last 7 days for self-harm, suicidal ideation, or a suicide attempt.
- Have a smart phone with an Australian phone number.
- Provide their consent to participate, including consent to allow the research team to access their hospital medical records for 12 months prior to enrolment and 12 months post enrolment in the study.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals are excluded from participation if they:
- Are not currently aged between 16 and 65 years old.
- Presented to the hospital with psychotic symptoms.
- Are not English literate.

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)
Allocation to group will be concealed. Participants will be randomised by computer (i.e. our online research platform). .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
This study uses a 2x2 factorial design with an additional waitlist arm.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The recruitment target for this study is n=125 participants aged 16-25, with an equal allocation of n=25 participants in the waitlist control group and each of the four intervention groups. Statistical power is calculated on n=20 participants in each group providing follow-up data. In a pilot study we achieved over 80% follow-up data collection up to six months, thus to account for loss to follow-up we will recruit n=25 for each group.

This sample size will allow for detection, in both of the factorial comparisons, of a small-to-moderate effect (f=0.14, equivalent to d=0.28) at 80% power which is likely to represent a clinically significant reduction in suicidal ideation. This sample size will also allow for detection of a moderate effect (f=0.20, d=0.40) between the optimal factorial combination and the waitlist control group.

While the study is powered primarily for the 16-25 year old age group, we will not exclude those aged 26-65 years from participating so we can also evaluate the suitability of the intervention in older adults. We will be accepting up to a maximum of n=125 26-65 year olds. Thus, our maximum sample size will be n=250.

The recruitment target is n=125 participants aged 16-25. However, we will also open recruitment for individuals aged 26-65 during the course of the study, accepting up to a maximum of n=125 26-65 year olds. Thus, our maximum sample size will be n=250.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID-19 pandemic.
Date of first participant enrolment
Anticipated
3/02/2020
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)
NSW,QLD
Recruitment hospital [1] 14597 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 15530 0
Ipswich Hospital - Ipswich
Recruitment hospital [3] 15531 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 15532 0
Redland Hospital - Cleveland
Recruitment hospital [5] 15533 0
Kingaroy Hospital & Community Health Centre - Kingaroy
Recruitment hospital [6] 15534 0
Warwick Hospital - Warwick
Recruitment postcode(s) [1] 27616 0
2050 - Camperdown
Recruitment postcode(s) [2] 28900 0
4305 - Ipswich
Recruitment postcode(s) [3] 28901 0
2139 - Concord
Recruitment postcode(s) [4] 28902 0
4163 - Cleveland
Recruitment postcode(s) [5] 28903 0
4610 - Kingaroy
Recruitment postcode(s) [6] 28904 0
4370 - Warwick

Funding & Sponsors
Funding source category [1] 303597 0
Charities/Societies/Foundations
Name [1] 303597 0
Australian Rotary Health
Country [1] 303597 0
Australia
Funding source category [2] 303610 0
Charities/Societies/Foundations
Name [2] 303610 0
Ottomin Foundation
Country [2] 303610 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Country
Australia
Secondary sponsor category [1] 303701 0
None
Name [1] 303701 0
Address [1] 303701 0
Country [1] 303701 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304126 0
Sydney Local Health District - RPAH Zone
Ethics committee address [1] 304126 0
Ethics committee country [1] 304126 0
Australia
Date submitted for ethics approval [1] 304126 0
17/06/2019
Approval date [1] 304126 0
15/08/2019
Ethics approval number [1] 304126 0
X19-0252

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

Contacts
Principal investigator
Name 95898 0
Dr Mark Larsen
Address 95898 0
Black Dog Insitute
Hospital Rd
Randwick, NSW 2031
Country 95898 0
Australia
Phone 95898 0
+61 2 93828508
Fax 95898 0
Email 95898 0
[email protected]
Contact person for public queries
Name 95899 0
Adam Theobald
Address 95899 0
Black Dog Institute
Hospital Rd
Randwick, NSW 2031
Country 95899 0
Australia
Phone 95899 0
+61 2 93829253
Fax 95899 0
Email 95899 0
[email protected]
Contact person for scientific queries
Name 95900 0
Mark Larsen
Address 95900 0
Black Dog Insitute
Hospital Rd
Randwick, NSW 2031
Country 95900 0
Australia
Phone 95900 0
+61 2 93828508
Fax 95900 0
Email 95900 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
Participants have not provided consent to share their individual data.


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.