Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001170516
Ethics application status
Approved
Date submitted
11/09/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Date results provided
25/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Caring contact SMS text messages following suicidal behaviour
Scientific title
Caring contact SMS text messages on mental health outcomes in adults following suicidal behaviour
Secondary ID [1] 312941 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal behaviour 335109 0
Condition category
Condition code
Mental Health 331612 331612 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Text message series sent to participants over a period of three months.
There are seven messages sent within week 1 of hospital presentation and at weeks 1, 2, 4, 7, 11 and 12 thereafter. There is also a birthday message if this date is within the timeframe of the text message series.
The messages are brief, each with a greeting and sign-off, 1-2 substantial sentences and link to further support. (For example, Kia ora [name],
We were thinking of you. Hope you are feeling uplifted in your Mauri (energy) today.
If you like to you can contact 1737 by free phone or text.
Nga mihi (Regards) [name])
The information sheet indicates to participants that messaging is one-way.
The author of the messages is the lead researcher.
Adherence to messages was not monitored. Participants are asked about their experience of receiving messages in qualitative interviews after the final message is sent.
Intervention code [1] 329472 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339345 0
Assessment of self-agency in response to receiving text messages.
Assessment method: Qualitative impact of SMS on service users.
Timepoint: 3 months
Timepoint [1] 339345 0
Once only evaluation after completiion of 3-month text message series
Secondary outcome [1] 439607 0
No evaluation of secondary outcomes
Timepoint [1] 439607 0
Not applicable

Eligibility
Key inclusion criteria
Adult service users age 18-65
Presentation to Emergency Department following suicidal behaviour
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not competent to consent (acute psychiatric illness)

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
15/12/2023
Date of last data collection
Anticipated
Actual
29/03/2024
Sample size
Target
15
Accrual to date
Final
7
Recruitment outside Australia
Country [1] 26554 0
New Zealand
State/province [1] 26554 0

Funding & Sponsors
Funding source category [1] 317376 0
Other
Name [1] 317376 0
Oakley Mental Health Foundation
Country [1] 317376 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 319665 0
Government body
Name [1] 319665 0
Te Whatu Ora Health New Zealand
Address [1] 319665 0
Country [1] 319665 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316105 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316105 0
Ethics committee country [1] 316105 0
New Zealand
Date submitted for ethics approval [1] 316105 0
04/04/2022
Approval date [1] 316105 0
31/05/2022
Ethics approval number [1] 316105 0
HDECS 2022 EXP 12543

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

Contacts
Principal investigator
Name 136798 0
Dr Lillian Ng
Address 136798 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country 136798 0
New Zealand
Phone 136798 0
+64 93737599
Fax 136798 0
Email 136798 0
[email protected]
Contact person for public queries
Name 136799 0
Lillian Ng
Address 136799 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country 136799 0
New Zealand
Phone 136799 0
+64 93737599
Fax 136799 0
Email 136799 0
[email protected]
Contact person for scientific queries
Name 136800 0
Lillian Ng
Address 136800 0
The University of Auckland, Private Bag 92019, Auckland 1142
Country 136800 0
New Zealand
Phone 136800 0
+64 93737599
Fax 136800 0
Email 136800 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.