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Trial registered on ANZCTR


Registration number
ACTRN12617000577314
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
24/04/2017
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation trial of ‘iConsiderLife’: A self-help, crisis and suicide prevention decision-support program to assist in reducing distress in adults.
Scientific title
An evaluation trial of ‘iConsiderLife’: An automated (self-help), crisis and suicide prevention decision-support digital health program, to assist in reducing self-reported psychological distress ratings in adults.
Secondary ID [1] 291142 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 301989 0
Crisis Support 302791 0
Suicidal Thoughts 302792 0
Condition category
Condition code
Mental Health 301632 301632 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An automated (self-help) decision-support crisis and suicide prevention program (called iConsiderLife) will be evaluated by investigating the ways in which adults use iConsiderLife. The iConsiderLife program is one of the My Digital Health platform programs.

Adults visiting one of the My Digital Health sites will be able to find a link to iConsiderLife within the ‘Crisis and General Support Services’ page. This page provides the general public with information and links to crisis (e.g., Life Line) and mental health service providers. In response to clicking the iConsiderLife link or hearing about the iConsiderLife program, adults will be invited to participate in the study.

Adults wishing to participate in the iConsiderLife evaluation study will be provided with immediate access to the single-session program, following the provision of their informed consent to participate in the study and answering several brief demographic / personal questions. Adults who do not wish to participate in the evaluation study will be provided with a list of alternative sources of support. In addition, adults wishing to participate in the trial will not have to create an account in order to access the program.

iConsiderLife is designed to provide adults who are currently distressed or experiencing a crisis with a simple, step-by-step, problem solving approach design, to assist in reducing this distress in real time. There are six main strategy sections. The six main strategy sections include:

1) A section with encourages the participant to speak with family, friends, healthcare professionals, crisis support services and emergency services about how they are currently feeling.
2) A section that explores the common thoughts and experiences that distressed or suicidal people have.
3) A section that provides the person with several distress reducing activities (e.g., breathing control, mindfulness of breath).
4) A section that asks the person to consider and reflect upon the people and things that are/have been important to them (e.g., people, pets, hobbies). This section focuses on reasons for living.
5) A section that provides lists a range of distraction and provides brief instructions on how to get started.
6) A section that asks people to reflect on a range of questions that are aimed at increasing hope.

Depending on how the person responds they are provided with additional information in relation to the current strategy or taken to the next strategy section. For example, if a person was not interested in undertaking any distress reducing activities, they would click on 'no' (i.e., to the question asking them if they interested in trying out a distress reducing activity) and then they would be taken to the next strategy (i.e., reflection / reasons for living). If the person was interested in doing the reflection activities, they would click on the 'yes' button and then they would be taken to the specific reflection-based exercises for this strategy grouping. Overall, if a person was to say ‘no’ to each question within the program, it would take them approximately 3 minutes to complete.

iConsiderLife has been designed as a ‘single-session’ program to assist people in 'real time' and participants are not required to create an account to use the program. People are able to come back and undertake another single-session should they require it but as the program does not require an account to be created, it cannot remember who they are once they have closed their browser. Therefore, people who do return to use iConsiderLife sometime into the future will need to start from the beginning.

People are asked their age, gender, what country they reside in, postcode if Australian, whether or not they are currently under the influence of alcohol and other drugs, and their current level of distress (scale from 0 – 100). Once people reach the end of iConsiderLife, or opt out early because they are no longer feeling as distressed, the person is asked to re-rate their distress level and they are then provided with some additional feedback / information.

The flow (e.g., what sections people visit the most) and their before and after distress ratings will be explored to examine the usefulness of the program.
Intervention code [1] 297125 0
Prevention
Intervention code [2] 297289 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301030 0
Distress rating - 10 point scale from 0 (not distressed at all) to 10 (maximum distress).
Timepoint [1] 301030 0
Participants will be asked to rate their current level of distress at the beginning of the program and just before participant is about to leave the program.
Secondary outcome [1] 331517 0
Demographic questions (age, gender, country of residence, relationship status)
Timepoint [1] 331517 0
Beginning of program

Eligibility
Key inclusion criteria
Participants must be 18 years or older.

iConsiderLife has been developed for adults who are currently distressed or experiencing suicidal thoughts and therefore recruitment will focus on people who are distressed. However, given this is an open access program, adults who are not distressed can also access it if they wish. The program is preventative in nature, therefore 'healthy' participants may also benefit from some of the information within the program (e.g., distress tolerance activities) but it was not developed for this purpose.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No internet access and does not consent to study conditions,

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
A simple pre- and post program t test will be utilised to evaluate the impact of using iConsiderLife. We will also investigate any differential effects based on the participants responses to the personal / demographic questions (e.g., age, gender).

Assuming a conservative small effect (i.e. GPower dz test = 0.20), significance set at 5% (p = .05), and power at 80%, a sample of 156 will be required to demonstrate statistical significance on the primary analysis. However allowing for a 50% attrition rate (participants not answering the second distress rating), we will be required to recruit 312 participants to use iConsiderLife.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8820 0
New Zealand
State/province [1] 8820 0
Country [2] 8821 0
United States of America
State/province [2] 8821 0
Country [3] 8823 0
Canada
State/province [3] 8823 0

Funding & Sponsors
Funding source category [1] 295579 0
University
Name [1] 295579 0
Federation University
Address [1] 295579 0
University Drive, Mt Helen Campus, Victoria, 3350
Country [1] 295579 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 294410 0
None
Name [1] 294410 0
Address [1] 294410 0
Country [1] 294410 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296901 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 296901 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663 Ballarat VIC 3353.
Ethics committee country [1] 296901 0
Australia
Date submitted for ethics approval [1] 296901 0
01/11/2016
Approval date [1] 296901 0
16/02/2017
Ethics approval number [1] 296901 0
A16-160

Summary
Brief summary
An automated (self-help) decision-support crisis and suicide prevention program (called iConsiderLife) will be evaluated.

The iConsiderLife program is one of the My Digital Health platform programs. People visiting one of the My Digital health sites will be able to find a link to iConsiderLife within the ‘Crisis and General Support Services’ page. This page provides the general public with information and links to crisis and mental health service providers. In response to clicking the iConsiderLife link or hearing about the iConsiderLife site, people will be invited to participate in the study.

People wishing to participate in the iConsiderLife evaluation study will be provided with immediate access to the program, following the provision of their informed consent to participate in the study and answering several brief demographic / personal questions. People who do not wish to participate in the evaluation study or are under 18 years of age will be provided with a list of alternative sources of support.

iConsiderLife is designed to provide people who are currently distressed or experiencing a crisis with a simple, step-by-step, problem solving approach design, to assist in reducing this distress in real time. There are six key sections that participants are guided through one by one.

If a person was to say ‘no’ to each question within the program, it would take them approximately 3 minutes to complete. People are asked their age, gender, what country they reside in, postcode if Australian, whether or not they are currently under the influence of alcohol and other drugs, and their current level of distress (from 0 – 100). Once people reach the end of iConsiderLife, or opt out early because they are no longer feeling as distressed, the person is asked to re-rate their distress level and they are then provided with some additional feedback / information.

The flow (e.g., what sections people visit most) and their before and after distress ratings will be explored to examine the effectiveness of the program. It is expected that people who use the iConsiderLife program will feel less distressed once they have finished using it.
Trial website
https://iconsiderlife.mydigitalhealth.org.au
Trial related presentations / publications
Public notes
iConsiderLife is globally accessible via the web.

Contacts
Principal investigator
Name 72374 0
Prof Britt Klein
Address 72374 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72374 0
Australia
Phone 72374 0
+61 3 5327 6717
Fax 72374 0
Email 72374 0
b.klein@federation.edu.au
Contact person for public queries
Name 72375 0
Prof Britt Klein
Address 72375 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72375 0
Australia
Phone 72375 0
+61 3 5327 6717
Fax 72375 0
Email 72375 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 72376 0
Prof Britt Klein
Address 72376 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72376 0
Australia
Phone 72376 0
+61 3 5327 6717
Fax 72376 0
Email 72376 0
b.klein@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Relevant individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
No start or end date as yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Case-by-case basis at the discretion of Principal Investigator.
How or where can data be obtained?
Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the de-identified data and approval granted.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 926 0
Informed consent form
Citation [1] 926 0
Link [1] 926 0
Email [1] 926 0
Other [1] 926 0
https://iconsiderlife.mydigitalhealth.org.au/consent/
Attachment [1] 926 0
Summary results
No Results