Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001734853
Ethics application status
Approved
Date submitted
27/10/2021
Date registered
20/12/2021
Date last updated
2/12/2022
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Reconnecting After Self-Harm. A trial of a text-message based intervention after self-harm.
Scientific title
RAFT: Reconnecting After Self-Harm. A trial of a text-message based, brief contact intervention to reduce suicidal ideation and repeat self-harm among adults who present to hospital after self-harm.
Secondary ID [1] 304932 0
Nil
Universal Trial Number (UTN)
U1111-1268-4251
Trial acronym
Linked study record
ACTRN12616000266460 (pilot study that preceded the current trial).

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 323081 0
Self harm 323082 0
Suicide 323083 0
Condition category
Condition code
Mental Health 320658 320658 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RAFT is a text-message based, brief contact intervention for individuals who have recently presented to hospital for self-harm or a suicide attempt. RAFT aims to reduce suicidal ideation and repeat self-harm. RAFT sends a series of automated ‘caring contact’ text messages with links to brief, self-guided, low-intensity therapeutic modules that target proximal risk factors for self-harm – distressing thoughts, safety planning, emotional regulation, suicidal thoughts, interpersonal relationships and alcohol. These modules are hosted on a dedicated RAFT website (not publicly available) and each module takes approximately 10 minutes to complete. The therapeutic content was co-developed by clinicians and lived experience representatives for the purposes of this intervention. It provides suggestions for distraction techniques, safety planning templates, mindfulness techniques, and basic cognitive-behavioural therapy around challenging unhelpful thoughts.
Participants will be randomised between: (a) an intervention using a 2x2 factorial design or (b) a control group who will receive treatment as usual (TAU). Participants assigned to the intervention group will be randomised between two factors: (1) participant receiving text messages alone with no links to the online therapeutic modules Vs participants receiving text messages with links to the online therapeutic modules; and (2) participant having the option to nominate a support person to receive a one-off text message Vs participants not having this option. Participants who are assigned to groups which do not receive a link to the online modules text messages, which express the hope that the individual is doing well and provides contact details for crisis services.
The text message for the nominated support person, send 1 day after the participant enrols in the trial, includes the first name of the participant who nominated them, a brief statement that supporting a friend or family member through a difficult time can be challenging, and a link to a dedicated section of the RAFT website (not accessible to the public) that contains information about self-harm and suicidal thinking, safety planning, and links to external resources for carers (e.g. Beyond Blue). The body of the text message takes approximately 1 minute to read, the information on the support-person website takes approximately 15 minutes to read, and the external links are able to be accessed at the persons discretion.
The primary aim is to determine whether the RAFT text message intervention reduces suicidal ideation compared to the control group. It also aims to assess whether the inclusion of links to therapeutic content is beneficial compared to just sending text messages, and whether sending additional information to a nominated support person (e.g. a family member or friend) is beneficial compared to sending messages to the participant alone.
Participants assigned to an intervention group will receive a text message on Days 1, 3, 8, 15, 22 and 29 and then monthly for 12 months. Self-report data on suicidal ideation, self-harm behaviour, psychological distress, functioning and recovery, quality of life and alcohol use will be captured at baseline, 5 weeks, 6 months and 12 months. A data linkage at 24 months will capture emergency department and hospital admissions data.
Participants are able to engage with the therapeutic content as often or as little as desired. The RAFT website will automatically track how often an individual accesses the therapeutic content.
Intervention code [1] 321328 0
Treatment: Other
Comparator / control treatment
The control group will receive treatment as usual i.e. standard follow-up care offered by their treating hospital. Participants in the control group will receive a text message at baseline, 5 weeks, 6 months and 12 months with a link to complete the study questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 328478 0
Suicidal ideation as measured by the Suicidal Ideation Attributes Scale.
Timepoint [1] 328478 0
Baseline, 5 weeks (primary timepoint), 6 months and 12 months.
Secondary outcome [1] 399166 0
Event rate of repeat self-harm as measured by the modified Self-Injurious Thoughts and Behaviours Interview.
Timepoint [1] 399166 0
Baseline, 5 weeks, 6 months and 12 months.
Secondary outcome [2] 403822 0
Repeat hospital presentations as measured by self-report
Timepoint [2] 403822 0
5 weeks, 6 months and 12 months
Secondary outcome [3] 403823 0
Functioning and recovery as measured by the Functioning and Recovery Scale
Timepoint [3] 403823 0
Baseline, 5 weeks, 6 months and 12 months
Secondary outcome [4] 403824 0
Days out of role as measured by 1 item in the WHO Disability Assessment Schedule
Timepoint [4] 403824 0
Baseline, 5 weeks, 6 months and 12 months
Secondary outcome [5] 403825 0
Psychological distress as measured by the Distress Questionnaire-5
Timepoint [5] 403825 0
Baseline, 5 weeks, 6 months and 12 months
Secondary outcome [6] 403826 0
Quality of life as measured by the Assessment of Quality of Life–8D
Timepoint [6] 403826 0
Baseline, 6 months and 12 months
Secondary outcome [7] 403827 0
Alcohol use as measured by the Alcohol Use Disorders Identification Test
Timepoint [7] 403827 0
Baseline, 5 weeks, 6 months and 12 months

Eligibility
Key inclusion criteria
18-65 years old.
Presented at a hospital within the last seven days for self-harm or a suicide attempt.
Are English literate.
Have a smartphone with an Australian phone number.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experienced psychotic symptoms in the past 7 days.

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 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
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The recruitment target is 555 participants, allocated evenly between four intervention groups and a control group (i.e. n=111 in each group). The sample size is powered to detect small changes (d=0.2) between the intervention groups and the control group in the primary outcome of suicidal ideation severity with 90% power, accounting for up to 45% attrition from self-report assessments. This effect size estimate is based on a recent meta-analysis of digital interventions for suicide prevention and their impact on suicidal ideation, which found an effect size post-intervention of g=0.18 (based on any intervention) and g=0.23 (for interventions specifically targeting suicidality) favouring interventions.
All available participant data will be utilised following intention-to-treat principles. All participants will be included regardless of treatment received or withdrawal from the study. The primary outcome measure (suicidal ideation) will be analysed using linear mixed model with repeated measures (MMRM) analysis. MMRM analyses will be used as this approach provides an intent-to-treat analysis including all available data from participants under the missing at random assumption rather than excluding those with missing data or using biased techniques such as last observation carried forward. We will assess the sensitivity of our assumptions on the patterns of missing data. Potential moderators of outcome such as gender and age will be explored and controlled for in secondary analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/01/2022
Actual
4/03/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
555
Accrual to date
150
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309312 0
Charities/Societies/Foundations
Name [1] 309312 0
Suicide Prevention Australia
Country [1] 309312 0
Australia
Funding source category [2] 309336 0
Charities/Societies/Foundations
Name [2] 309336 0
Australian Rotary Health
Country [2] 309336 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 310302 0
None
Name [1] 310302 0
Address [1] 310302 0
Country [1] 310302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309140 0
Sydney Local Health District Ethics Review Committee - RPAH Zone
Ethics committee address [1] 309140 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown, NSW 2050
Ethics committee country [1] 309140 0
Australia
Date submitted for ethics approval [1] 309140 0
02/10/2020
Approval date [1] 309140 0
20/07/2021
Ethics approval number [1] 309140 0
X20-0445

Summary
Brief summary
Suicide is the leading cause of death for young people in Australia and hospital treated self-harm is the strongest risk factor for subsequent suicide. Brief contact interventions (BCI) after patients have been discharged have been shown to reduce repeat self-harm. RAFT is an SMS-based BCI that links patients with self-guided therapeutic content. This study will recruit individuals who have recently attended a hospital or emergency department for self-harm. Participants will be assigned to an intervention arm or a treatment-as-usual (TAU) control group. Participants assigned to the intervention arm will receive supportive text messages over 12 months. Adopting a 2x2 factorial design, half the participants assigned to the intervention arm will receive access to the self-guided therapeutic content. Additionally, half the participants assigned to the intervention arm will have the option to nominate a support person to receive information about self-harm and suicide.
RAFT is aimed at reducing suicidal ideation and self-harm. This trial will assess whether RAFT is effective compared to treatment as usual, with exploration of the most effective combination of RAFT features. It is hypothesised that participants in the intervention arm will demonstrate greater reductions in suicidal ideation and the event rate of repeat self-harm relative to the control group.
Self-report data will be collected remotely via online questionnaires at baseline, 5 weeks, 6 months and 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113126 0
Dr Mark Larsen
Address 113126 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 113126 0
Australia
Phone 113126 0
+612 9065 9145
Fax 113126 0
Email 113126 0
[email protected]
Contact person for public queries
Name 113127 0
Mr Adam Theobald
Address 113127 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 113127 0
Australia
Phone 113127 0
+612 9065 9038
Fax 113127 0
Email 113127 0
[email protected]
Contact person for scientific queries
Name 113128 0
Dr Mark Larsen
Address 113128 0
Black Dog Institute
Hospital Rd
Randwick NSW 2031
Country 113128 0
Australia
Phone 113128 0
+612 9065 9145
Fax 113128 0
Email 113128 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.