Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000607370
Ethics application status
Approved
Date submitted
22/04/2017
Date registered
28/04/2017
Date last updated
12/11/2021
Date data sharing statement initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SMS SOS: Using SMS text messages to prevent self-harm
Scientific title
SMS SOS: Effectiveness of SMS text messages in improving survival and rehabilitation rates of deliberate self harm patients and reducing re-presentation of DSH patients to hospital.
Secondary ID [1] 291709 0
New South Wales Ministry of Health, Translational Research Grant Scheme, 2016, TRGS Application No: 155.
Universal Trial Number (UTN)
U1111-1195-7926
Trial acronym
Not Applicable
Linked study record
Not Applicable

Health condition
Health condition(s) or problem(s) studied:
Deliberate self-poisoning 302882 0
Deliberate self-injury 302883 0
Condition category
Condition code
Injuries and Accidents 302368 302368 0 0
Poisoning
Injuries and Accidents 302369 302369 0 0
Other injuries and accidents
Mental Health 302370 302370 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-drug trial.
Individuals who present to hospital Emergency Departments with deliberate self-harm, and who meet eligibility criteria, will be randomly allocated to one of two follow up conditions:
1a. Control group: will receive hospital follow-up treatment-as-usual (TAU). This consists of hospital and/or community mental health contact with the presenting individual, typically within 24 hours of their presentation, and a follow-up program of care including clinical re-assessment and individual or family-based psychological therapies, as indicated.
1b. Intervention group: will receive TAU plus supportive Short Message Service (SMS) text messages (TAU + SMS) scheduled at 1,2,3,4,5,6,8,10 and 12 months after their index presentation/randomisation.

The content of the SMS message uses the following wording:

TEXT MESSAGE 1:
Dear NAME.
We hope that things have been going well for you since we last had contact.
Just a reminder that the 24-hour contact line 13 11 14 is there if you’d like to connect with someone and Helpline staff
1800 011 511 can put you in touch with your local health service if needed.
Best wishes.
[Return SMS messages are unavailable from this service.]

TEXT MESSAGE 2:
Dear NAME.
Just checking in with you.
A reminder that help is there if you need it. Just call 13 11 14 or 1800 011 511.
Best wishes.

TEXT MESSAGE 3:
Hi NAME.
We hope that you’ve been ok since our last contact. We’re just checking in with you.
A 24-hour phone line is there for you in case you’d like to connect with someone 13 11 14 or to contact your local health service 1800 011 511.
Best wishes.

Mode of Delivery:
The scheduled delivery of supportive SMS text messages will occur via an automated text messaging service, with this process being overseen by project research officers.
Frequency and duration of intervention:
Participants in the intervention condition will receive SMS text messages over 12 months on an identical time schedule; 1, 2, 3, 4, 5, 6, 8, 10 and 12 months after their index admission/randomisation. The message (detailed above) will be scheduled as Text Message 1, 2, 3, then 2 and 3 rotated. Due to any potential concerns regarding ongoing surveillance, there will be no direct monitoring of message receipt or opening.
Intervention code [1] 297797 0
Behaviour
Intervention code [2] 297883 0
Treatment: Devices
Intervention code [3] 297884 0
Treatment: Other
Comparator / control treatment
The control group will receive hospital follow-up treatment as usual (TAU) which consists of hospital and/or community mental health contact with the presenting individual, typically within 24 hours of their presentation, and a follow-up program of care including clinical re-assessment and individual or family-based psychological therapies, as indicated.
Control group
Active

Outcomes
Primary outcome [1] 301783 0
Number of deliberate self-harm (DSH) re-presentations to hospital Emergency Departments within 12 months following index presentation/randomisation. All primary and secondary outcomes of the study will be assessed by review of hospital medical records at the three study sites, as well as data linkage to hospital admission records of all New South Wales hospitals.
Timepoint [1] 301783 0
Any DSH re-presentation within 12 months following index presentation/randomisation.
Primary outcome [2] 301784 0
Median time of first DSH re-presentation to hospital Emergency Department within 12 months following index presentation/randomisation.
Timepoint [2] 301784 0
Median time of first DSH re-presentation within 12 months following index presentation/randomisation.
Secondary outcome [1] 333865 0
Mortality rate
Timepoint [1] 333865 0
Mortality rate within 12 months of index presentation/randomisation.

Eligibility
Key inclusion criteria
Individuals will be eligible for study inclusion if they present with DSH during the recruitment period, have access to a mobile phone for personal use and are aged 16 years and over. We will include individuals who present with either a first or subsequent episode of DSH.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are incapable of or unwilling to give informed consent, those of no fixed address, those with insufficient English to read an SMS, and those without a mobile phone, will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to the control group (Treatment As Usual - TAU) and intervention (experimental) group (SMS+TAU) was 'concealed' to enrolling mental health clinicians (by sealed, randomized numbered green and blue envelopes stored in enrolment drawers) before they determined patients were eligible for inclusion in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants will be stratified by first DSH presentation or subsequent DSH presentation. Participants will then be randomised within strata, using random permuted blocks, to either the intervention (SMS+TAU) group or the control (TAU) group using a computer-generated randomisation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation and enrolment of participants:
To minimise participant burden, a randomised consent design (Zelen: single consent version) will be used (Zelen, 1979, 1990). This design is a variation on the standard randomised controlled experimental design, in which participants are randomised to control or intervention before consent is sought. In the single consent version, written informed consent to receive the intervention (nine scheduled SMS text messages) is sought only from participants randomised to the intervention condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations:
Our study is powered to detect a clinically important difference in outcomes for all patients. Assuming an incidence rate ratio (based on event rates) of RR=0.66 for the intervention group compared to the control group, with a 5% significance level and 80% power and 10% adjustment for correlation of individuals within centres, a total sample size of 796 participants is required (398 in the intervention group and 398 in the control group). This assumes a median survival time (time to first repetition) in the control group of 4.3 years. Currently ~15% in the usual care group who present for DSH re-present within the following 12-months, or a probability of survival of 0.85. Median survival (m) after 1 year (t) in the usual care group = t*loge(1/2)loge(p) = 4.3 years. For assessing differences in median time to first repetition, assuming a median survival time in the usual care group of 73.5 days and a similar relative difference in event rates between intervention and controls groups as above (RR=0.66), the estimated median survival time in the intervention group is 121.8 days, which requires a total sample size of 138 participants (69 participants in the intervention group and 69 participants in the control group), with 5% significance and 80% power, and 10% adjustment for correlation of individuals within centres. The number of patients likely to die within the study period is very small. A previous longitudinal study in our centre found a 1% suicide rate after 24 months and nearly a 2% suicide rate after 5 years. These are lower than the 12-month 1.8% rate reported in a recent meta-analysis of psychosocial interventions after self-harm.
Feasibility:
Our records show that there are about 650 DSH presentations to the three WSLHD study-sites annually i.e. approximately 1300 potential participants. We would anticipate, based on previous research, that approximately 15% of all DSP presentations will not meet the eligibility criteria (1105 eligible), 10% will not consent to study participation (i.e. the consent rate in our previous Postcards study), leaving approximately 995 potential participants over the 24-month recruitment period. It is anticipated that approximately 55% of participants will be women, thus there would be an estimated total of 547 (273 in the intervention group and 273 in the control group) women and 448 (224 in the intervention group and 224 in the control group) men, representing a sufficient sample size to evaluate the effect of the intervention for all participants.
Statistical methods:
Characteristics of participants will be compared between intervention groups using the t-test or a non-parametric equivalent for continuous variables and the X2 or Fisher’s exact for categorical variables. The primary analysis will involve comparing the number of participant re-presentations, or deaths, related to DSH in each group in the 12 months following recruitment. The number of re-admissions per patient (within 12 months following recruitment) in the intervention and control group will be compared using negative binomial regression, and differences between median time to first repetition between intervention and control group will be compared using survival analysis. Based on the Postcards from the EDge study the negative binomial is the most likely distribution for the number of DSH episodes per individual. If any baseline characteristics known to be associated with DSH readmission differ between the two intervention groups, these variables will be included in a secondary analysis which involves including imbalanced variables and other important covariates in a logistic (for any DSH readmission) or negative binomial (for the number of DSH readmissions) regression model. All analyses will be intention to treat, with all patients being analysed according to their intervention group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2017
Actual
3/10/2017
Date of last participant enrolment
Anticipated
3/10/2019
Actual
16/12/2019
Date of last data collection
Anticipated
3/10/2020
Actual
6/05/2021
Sample size
Target
796
Accrual to date
Final
806
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7854 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 7855 0
Westmead Hospital - Westmead
Recruitment hospital [3] 7856 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 15797 0
2148 - Blacktown
Recruitment postcode(s) [2] 15798 0
2145 - Westmead
Recruitment postcode(s) [3] 15799 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 296209 0
Government body
Name [1] 296209 0
Translational Research Grant Scheme (TRGS), New South Wales Ministry of Health
Country [1] 296209 0
Australia
Primary sponsor type
Individual
Name
Prof Alison Jones
Address
Northfields Ave
Building 41, Room 260
Faculty of Science, Medicine and Health,
University of Wollongong,
Wollongong, NSW, 2522
Country
Australia
Secondary sponsor category [1] 295117 0
Individual
Name [1] 295117 0
Dr Naren Gunja
Address [1] 295117 0
Department of Pharmacology & Toxicology
Blacktown Hospital
18 Blacktown Road
Blacktown, NSW, 2148

Country [1] 295117 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297448 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297448 0
Ethics committee country [1] 297448 0
Australia
Date submitted for ethics approval [1] 297448 0
16/08/2016
Approval date [1] 297448 0
28/09/2016
Ethics approval number [1] 297448 0
AU RED HREC/16/WMEAD/336 (Research Office File No. 4826)
Ethics committee name [2] 303552 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [2] 303552 0
Ethics committee country [2] 303552 0
Australia
Date submitted for ethics approval [2] 303552 0
25/08/2017
Approval date [2] 303552 0
01/09/2017
Ethics approval number [2] 303552 0
HREC/16/WMEAD/336 / SSA/16/NEPEAN/170

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1637 1637 0 0
/AnzctrAttachments/372752-SMS SOS_Study protocol_SPIRIT Checklist_2013 version_Final.doc (Protocol)
Attachments [2] 1638 1638 0 0
/AnzctrAttachments/372752-Ethics Approval letter_WSLHD HREC_20082016.pdf (Ethics approval)
Attachments [3] 1639 1639 0 0
/AnzctrAttachments/372752-WSLHD HREC PICF_Local vesion_Westmead_final.doc (Participant information/consent)
Attachments [4] 1652 1652 0 0
/AnzctrAttachments/372752-Scientific Advisory Comm_review letter_2018_001.pdf (Supplementary information)

Contacts
Principal investigator
Name 74066 0
Prof Alison Jones
Address 74066 0
Northfields Ave
Building 41 Room 260
Faculty of Science, Medicine and Health,
University of Wollongong, NSW, 2522
Country 74066 0
Australia
Phone 74066 0
+61 2 4221 5151
Fax 74066 0
Email 74066 0
[email protected]
Contact person for public queries
Name 74067 0
Garry Stevens
Address 74067 0
School of Social Sciences
Humanitarian and Development Studies
Kingswood Campus, P.G.86
Western Sydney University
Locked Bag 1797, Penrith 2751, NSW, Australia
Country 74067 0
Australia
Phone 74067 0
+61421079011
Fax 74067 0
Email 74067 0
[email protected]
Contact person for scientific queries
Name 74068 0
Alison Jones
Address 74068 0
Northfields Ave
Building 41 Room 260
Faculty of Science, Medicine and Health,
University of Wollongong, NSW, 2522
Country 74068 0
Australia
Phone 74068 0
+61 2 4221 5151
Fax 74068 0
Email 74068 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
Participant data in this trial are based on individual patient records held by WSLHD and NBMLHD. Ethics and governance approvals for Westmead, Blacktown, and Nepean Hospitals do not allow for data to be disseminated to third parties (not otherwise specified in the approvals) outside of the LHDs.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14055Study protocolStevens, G.J., Hammond, T.E., Brownhill, S. et al. SMS SOS: a randomized controlled trial to reduce self-harm and suicide attempts using SMS text messaging. BMC Psychiatry 19, 117 (2019). https://doi.org/10.1186/s12888-019-2104-9https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-019-2104-9[email protected]
14056Study protocol    372752-(Uploaded-10-08-2021-13-43-18)-Study-related document.pdf
14057Ethical approval    372752-(Uploaded-10-08-2021-13-48-15)-Study-related document.pdf
14058Ethical approval    372752-(Uploaded-10-08-2021-13-49-44)-Study-related document.pdf
14059Informed consent form    372752-(Uploaded-10-08-2021-13-52-56)-Study-related document.pdf
14060Informed consent form    372752-(Uploaded-10-08-2021-13-53-35)-Study-related document.pdf
14061Informed consent form    372752-(Uploaded-10-08-2021-13-54-06)-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
SourceTitleYear of PublicationDOI
EmbaseSMS SOS: A randomized controlled trial to reduce self-harm and suicide attempts using SMS text messaging.2019https://dx.doi.org/10.1186/s12888-019-2104-9
N.B. These documents automatically identified may not have been verified by the study sponsor.