Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000266460
Ethics application status
Approved
Date submitted
25/02/2016
Date registered
29/02/2016
Date last updated
28/03/2022
Date data sharing statement initially provided
20/12/2018
Date results information initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of a text message brief intervention following a suicide attempt
Scientific title
A feasibility study of an SMS-based brief intervention following a suicide attempt
Secondary ID [1] 288556 0
Nil known
Universal Trial Number (UTN)
U1111-1179-7122
Trial acronym
RAFT (Reconnecting after a suicide attempt)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide attempt 297667 0
Condition category
Condition code
Mental Health 297850 297850 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a series of text messages related to key strategies for reducing suicidal behaviour (safety planning, emotional regulation, coping with suicidal thoughts, interpersonal problem solving, and a brief alcohol intervention). The messages will contain a link to a web site, allowing participants to find out more information and to link to other resources. Participants will receive 6 x weekly text messages, then reminders of the previous content will be sent monthly until 12 months. Messages will be automatically sent to participants, and the system will collect information on which links are followed and which online pages are viewed.
Intervention code [1] 293934 0
Treatment: Devices
Intervention code [2] 293935 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297375 0
Episodes of deliberate self-harm in the previous 12 months as assessed by data linkage to medical records
Timepoint [1] 297375 0
12 months
Secondary outcome [1] 320879 0
Episodes of deliberate self-harm in the previous 12 months self-reported by participant via study-specific online questionnaire
Timepoint [1] 320879 0
Baseline, 6 months, 12 months
Secondary outcome [2] 320880 0
Suicidal ideation measured by the Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [2] 320880 0
Baseline, 6 months, 12 months
Secondary outcome [3] 320881 0
Social connectedness measured by the Interpersonal Needs Questionnaire (INQ)
Timepoint [3] 320881 0
Baseline, 6 months, 12 months
Secondary outcome [4] 321239 0
Acceptability of the intervention assessed through a semi-structured interview, offered to participants either face-to-face or by telephone
Timepoint [4] 321239 0
12 months
Secondary outcome [5] 321240 0
Usage of the intervention assessed through automatically collected usage data, including number of links within the text messages opened
Timepoint [5] 321240 0
12 months

Eligibility
Key inclusion criteria
Participants must:
* Be aged 16-65
* Have access to a mobile phone
* Have presented to an emergency department in the previous 7 days for deliberate self harm or suicidal behaviours
* Be willing to contact a crisis service should they feel distressed
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not have a psychotic disorder such as schizophrenia

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/05/2016
Actual
23/03/2017
Date of last participant enrolment
Anticipated
Actual
18/05/2018
Date of last data collection
Anticipated
Actual
11/07/2019
Sample size
Target
50
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 5283 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 7455 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [3] 9831 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 18612 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 292901 0
Charities/Societies/Foundations
Name [1] 292901 0
Society for Mental Health Research
Country [1] 292901 0
Australia
Funding source category [2] 292974 0
Charities/Societies/Foundations
Name [2] 292974 0
Ottomin Foundation
Country [2] 292974 0
Australia
Primary sponsor type
University
Name
Black Dog Institute / University of New South Wales
Address
Hospital Road
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 291746 0
None
Name [1] 291746 0
Address [1] 291746 0
Country [1] 291746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294401 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 294401 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown
NSW 2050
Ethics committee country [1] 294401 0
Australia
Date submitted for ethics approval [1] 294401 0
Approval date [1] 294401 0
15/02/2016
Ethics approval number [1] 294401 0
X15-0390

Summary
Brief summary
Suicide is a leading cause of death in Australia, and is the leading cause of death for young people. A previous suicide attempt is a strong predictor of death by suicide, and hospital-treated deliberate self-harm (DSH) is the single strongest risk factor for subsequent suicide. The one-year repetition rate for hospital-treated DSH is 16%, which increases to 30% for those with a history of previous suicidal behaviour. Following a suicide attempt, the first days after discharge from hospital is a particularly high-risk period. Continuity of care is critical, yet this is a time where individuals often lose contact with healthcare services.

There is considerable uncertainty about the most effective post-discharge interventions to reduce repetition, with non-significant reductions attained using a variety of techniques. Brief contact interventions, including post-discharge letters, green cards, telephone calls, and postcards, have reduced the number of repeat events, but digital delivery of brief contact interventions, such as SMS, email or social media, has not yet been evaluated.

The RAFT project is a single group, pre-post pilot study of a digitally-delivered brief intervention aimed at reducing repeat suicide attempts. RAFT will deliver text messages containing links to information and therapeutic content via mobile telephone, at specified intervals. To pilot this intervention, individuals aged 18 years or older who present to a participating hospital following a suicide attempt will be offered this intervention. After informed consent, baseline measures will be administered online. Follow-up measures will assess suicidal ideation and behaviour, and social connectedness. In addition, feasibility and acceptability of the intervention will be assessed by examining participants' use of the intervention materials and through semi-structured interviews.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63602 0
Dr Mark Larsen
Address 63602 0
Black Dog Institute
Hospital Road
Randwick
NSW 2031
Country 63602 0
Australia
Phone 63602 0
+61 2 93828508
Fax 63602 0
Email 63602 0
[email protected]
Contact person for public queries
Name 63603 0
Mark Larsen
Address 63603 0
Black Dog Institute
Hospital Road
Randwick
NSW 2031
Country 63603 0
Australia
Phone 63603 0
+61 2 93828508
Fax 63603 0
Email 63603 0
[email protected]
Contact person for scientific queries
Name 63604 0
Mark Larsen
Address 63604 0
Black Dog Institute
Hospital Road
Randwick
NSW 2031
Country 63604 0
Australia
Phone 63604 0
+61 2 93828508
Fax 63604 0
Email 63604 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
Data sharing not included in participant consent.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published 15 March 2022. Josifovski et al. (2022)... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot study of a text message and online brief contact intervention following self-harm or a suicide attempt: A mixed methods evaluation.2022https://dx.doi.org/10.1016/j.genhosppsych.2022.03.002
N.B. These documents automatically identified may not have been verified by the study sponsor.