Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000104752
Ethics application status
Approved
Date submitted
25/01/2013
Date registered
25/01/2013
Date last updated
20/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of a self-help app to support suicide prevention amongst Indigenous youth
Scientific title
A controlled pilot trial to evaluate the effect on suicidal ideation and mental health of a self-managed acceptance and commitment therapy based app delivered on tablets for youths with suicidal ideation compared against wait list control.
Secondary ID [1] 281828 0
None
Universal Trial Number (UTN)
U1111-1138-8199
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal ideation 288183 0
Condition category
Condition code
Mental Health 288541 288541 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a structured self-paced program that is delivered on a tablet device. The program consists of 3 acceptance and commitment therapy based modules, including strategies and tools to manage thoughts and emotions, and goal setting tips. Each module can take anywhere from 10 minutes to 1 hour to complete depending on what activities the participant chooses to engage in. Once all 3 modules are completed, a participant is free to repeat any module within the app. Participants will be asked to use the intervention for a duration of 6 weeks.
Intervention code [1] 286382 0
Treatment: Devices
Intervention code [2] 286383 0
Behaviour
Comparator / control treatment
A wait list control group will receive the same intervention immediately after the intervention group completes the program (6 weeks after start of program).
Control group
Active

Outcomes
Primary outcome [1] 288704 0
Depressive Symptom Inventory – Suicidality Subscale (DSI-SS)
Timepoint [1] 288704 0
Baseline and immediately after completion of program
Secondary outcome [1] 300791 0
Patient Health Questionnaire (PHQ-9) score
Timepoint [1] 300791 0
Screening, baseline and immediately after completion of program
Secondary outcome [2] 300792 0
Kessler Psychological Distress Scale (K10) score
Timepoint [2] 300792 0
Screening, baseline and immediately after completion of program
Secondary outcome [3] 300793 0
Barratt Impulsiveness Scale (BIS-11) score
Timepoint [3] 300793 0
Baseline and immediately after completion of program

Eligibility
Key inclusion criteria
Participants must:

1) Have suicidal thoughts but not be severely suicidal (i.e. no suicidal intent)
2) Agree to use the program for 6 weeks and complete questionnaires on at least 2 occasions
3) Be willing to make contact with Suicide Call Back Service
4) Live in Australia
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not:

1) Have been diagnosed with schizophrenia or related disorders
2) Score 15 or above on the PHQ-9
3) Score 30 or above on the K-10

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/02/2013
Actual
25/03/2013
Date of last participant enrolment
Anticipated
Actual
22/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 286613 0
Government body
Name [1] 286613 0
Australian Government; Department of Health and Aging
Country [1] 286613 0
Australia
Primary sponsor type
Individual
Name
Professor Helen Christensen
Address
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 285399 0
Individual
Name [1] 285399 0
Dr Fiona Shand
Address [1] 285399 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country [1] 285399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288686 0
Universities of New South Wales Human Research Ethics Committee
Ethics committee address [1] 288686 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 288686 0
Australia
Date submitted for ethics approval [1] 288686 0
05/02/2013
Approval date [1] 288686 0
07/03/2013
Ethics approval number [1] 288686 0

Summary
Brief summary
This project aims to investigate whether a self-help interactive program delivered via tablet devices can help Indigenous youth to reduce their suicidal ideation. Participants will be randomly assigned to either the intervention group, which includes therapeutic activities grounded in acceptance and commitment therapy or a wait list control group. We predict those using the intervention program will report reduced suicidal ideation and mental distress after using the program for 6 weeks.
Trial website
Trial related presentations / publications
Shand, F. L. Ridani, R., Tighe, J. & Christensen, H. (2013). The effectiveness of a suicide prevention app for indigenous Australian youths: Study protocol for a randomized controlled trial. Trials, 14:396
Public notes

Contacts
Principal investigator
Name 37282 0
Prof Helen Christensen
Address 37282 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country 37282 0
Australia
Phone 37282 0
+61 2 9382 3717
Fax 37282 0
Email 37282 0
h.christensen@blackdog.org.au
Contact person for public queries
Name 37283 0
Miss Rebecca Ridani
Address 37283 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country 37283 0
Australia
Phone 37283 0
+61 2 9382 8501
Fax 37283 0
Email 37283 0
r.ridani@unsw.edu.au
Contact person for scientific queries
Name 37284 0
Dr Fiona Shand
Address 37284 0
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country 37284 0
Australia
Phone 37284 0
+61 2 9382 9291
Fax 37284 0
Email 37284 0
fionas@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary