Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001235594
Ethics application status
Approved
Date submitted
2/11/2015
Date registered
11/11/2015
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a safety-planning smartphone application for improving capacity to cope with suicidal ideation among at-risk individuals.
Scientific title
Evaluation of a safety-planning smartphone application for improving capacity to cope with suicidal ideation among at-risk individuals.
Secondary ID [1] 287257 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation and behaviours 295874 0
Condition category
Condition code
Mental Health 296127 296127 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'BeyondNow' safety-planning smartphone application will be installed onto participants' smartphones for a period of two months. The BeyondNow app provides users with the ability to develop a structured, and personally useful list of coping and help-seeking strategies which can be used to help cope with suicidal ideation during times of distress or crisis. The app allows users to document personalised warning signs of an impending crisis, ways to keep their environment safe, reasons for living, coping and distraction strategies, socialisation strategies, social contacts and professional support services including inbuilt contacts for Lifeline, 000 emergency, and the Suicide Call Back Service. Users will spend around 40 minutes developing their safety plan and learning to use the app with study staff at the baseline session. The researchers will not actively monitor adherence to the intervention, however, aggregate data on app usage and participant self-report app usage will be gathered.
Intervention code [1] 292556 0
Behaviour
Intervention code [2] 293171 0
Prevention
Intervention code [3] 293233 0
Treatment: Other
Comparator / control treatment
No control group will be studied.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295800 0
Participant self-report ratings of confidence in coping with suicidal ideation, using questionnaires designed to assess suicide resilience and coping with suicidal ideation.
Timepoint [1] 295800 0
Change from baseline to end of intervention (8 weeks).
Secondary outcome [1] 316554 0
Change in frequency of use of coping strategies to manage suicidal ideation will be assessed using a self-report questionnaire designed specifically for this study.
Timepoint [1] 316554 0
Change from baseline to end of intervention (8 weeks).
Secondary outcome [2] 316973 0
Change in frequency and duration of suicidal ideation will be assessed using a semi-structured interview (Columbia Suicide Severity Rating Scale).
Timepoint [2] 316973 0
Change from baseline to end of intervention (8 weeks).
Secondary outcome [3] 316974 0
The frequency of engagement with BeyondNow app of the overall sample (aggregate data) will be assessed using google analytic services.
Timepoint [3] 316974 0
Data accumulated over 8 week trial.
Secondary outcome [4] 318505 0
User opinion on app functionality and design will be assessed using a self-report measure designed specifically for this study.
Timepoint [4] 318505 0
Data collected at 8 week follow-up.

Eligibility
Key inclusion criteria
16 years or older. Current or recent suicidal ideation or behaviour. Current engagement with a tertiary mental health service.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis.
Intellectual disability.
Insufficient English language skill to operate the application.

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)
This study is an open-label single-group trial. All participants will be allocated to the single treatment condition.
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
Participant's age, psychiatric diagnosis, and time in current psychiatric episode of care will be collected.

Regression analyses will be used to examine the effect of time with app on primary and secondary outcome variables.

The sample size was chosen based on recruitment feasibility and scope of the study. As no information on the relationships between variables in this study have been published, power and sample size calculations were not possible.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/11/2015
Actual
7/12/2015
Date of last participant enrolment
Anticipated
31/12/2016
Actual
13/10/2016
Date of last data collection
Anticipated
23/12/2016
Actual
Sample size
Target
60
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10084 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 291821 0
Charities/Societies/Foundations
Name [1] 291821 0
The Movember Foundation.
Country [1] 291821 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd
Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 290985 0
None
Name [1] 290985 0
Address [1] 290985 0
Country [1] 290985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293764 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 293764 0
Research Support Services
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [1] 293764 0
Australia
Date submitted for ethics approval [1] 293764 0
30/07/2015
Approval date [1] 293764 0
25/09/2015
Ethics approval number [1] 293764 0
15358A

Summary
Brief summary
The aim of this research is to evaluate the functionality, efficacy, and utility of a new safety planning smartphone application. The trial will involve including the use of the smartphone application into existing Monash Health mental health services. Participants will include 60 patients who have experienced recent suicidal ideation or behaviours. Participants will be recruited by their treating mental health clinician. First, research staff will train the treating clinicians and participants in the use of the smartphone application, and conduct baseline measurement of suicide ideation and/or behaviour, as well as suicide resilience using self-report measures. Participants will then undergo 'treatment as usual' under the management of their treating clinician for a period of two months. Research staff will then conduct post trial measurement of suicide risk and resilience along with qualitative data on smartphone application functionality and utility. Data on smartphone application usage will be collected via Google analytics software. This information will not include personal information stored in the application.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59446 0
Dr Glenn Melvin
Address 59446 0
Monash University Centre for Developmental Psychiatry & Psychology
Building #1
270 Ferntree Gully Road
Notting Hill
VIC 3168
Country 59446 0
Australia
Phone 59446 0
+613 9902 4562
Fax 59446 0
Email 59446 0
[email protected]
Contact person for public queries
Name 59447 0
Mr Daniel Gresham
Address 59447 0
Monash University Centre for Developmental Psychiatry & Psychology
Building #1
270 Ferntree Gully Road
Notting Hill
VIC 3168
Country 59447 0
Australia
Phone 59447 0
+613 9905 0163
Fax 59447 0
Email 59447 0
[email protected]
Contact person for scientific queries
Name 59448 0
Dr Glenn Melvin
Address 59448 0
Monash University Centre for Developmental Psychiatry & Psychology
Building #1
270 Ferntree Gully Road
Notting Hill
VIC 3168
Country 59448 0
Australia
Phone 59448 0
+613 9902 4562
Fax 59448 0
Email 59448 0
[email protected]

No information has been provided regarding IPD availability


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.