Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001626459p
Ethics application status
Submitted, not yet approved
Date submitted
22/11/2016
Date registered
24/11/2016
Date last updated
24/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
MindExpressTM: trial of a depression prevention program for young people vulnerable to depressive disorders
Scientific title
MindExpressTM: A randomised control trial of a tailored depression prevention resilience-building mentoring App for young people vulnerable to depressive disorders
Secondary ID [1] 290600 0
None known
Universal Trial Number (UTN)
U1111-1190-2178
Trial acronym
MINDEXPRESS
Linked study record
Wilde A, Whitton A, Mitchell P, Lenroot L, Trevena L, Schofield P. Pilot study of MindExpressTM: An online risk factor-based tailored depression preventive program for young adults with a familial risk of major depressive disorder. Book of Proceedings (peer reviewed) 15th International Mental Health Conference, Australia. 2014 25-27 August; Australian and New Zealand Mental Health Association.

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder, 301076 0
Bipolar disorder 301077 0
Condition category
Condition code
Mental Health 300852 300852 0 0
Depression
Mental Health 300853 300853 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MindExpress is an interactive smartphone application designed to reduce risk for depression in young people aged 16 to 25 years.
Step 1: Registration and log in. All participants who meet the eligibility criteria will register and choose an encrypted log in ID and password.

Step 2: Demographic measure. All participants and decliners will complete the sociodemographic measure (8 items).

Step 3 Baseline measures and Personal Profile - One session of 30 minutes.
3a) All eligible participants will enter the App and complete the Adolescent Depression Knowledge Questionnaire (ADKQ, 15 items)10 and the Child and Youth Resilience Measure (CYRM-12, 12 items)
3b) All participants will complete the Personal Profile (risk factor status questionnaire):
1. Genes, family and environment - Family history screen (FHS, 4 items), Patient Health Questionnaire (PHQ-9, 9 items) 2. Thinking Styles - Rumination Response Scale (RRS, 22 items); 3. Coping styles - the brief COPE inventory (14 items); 4. Social Connections - the social connectedness items from Household, Income and Labour Dynamics in Australia (HILDA) (10 items),; 5. Alcohol Use - Adolescent Alcohol Involvement Scale (AAIS, 10 items); 6. Cannabis Use - Adolescent Drug Involvement Scale (ADIS, 10 items); 7. Tough Times - List of Threatening Life Experiences (LTE-Q, 12 items); 8. Family Dynamics - Measure of Parenting Styles (MOPS, 15 items).

Step 4: Randomisation: Participants will be randomised to receive MindExpress (the intervention) or HealthWatch (the attention-control) using a using a pre-programmed randomiser. Participants will be blinded to their randomised assignment and told that the study is comparing different types of health Apps.

Step 5:
5a) MindExpress Intervention arm: Education and CBT component – four x 30 minute sessions over 8 weeks spaced two weeks apart: Participants in the MindExpress arm will be automatically directed to complete three compulsory interactive education and CBT modules modules (Genes, family and environment, Thinking Styles and Coping Styles) plus one of five best-practice interactive CBT modules most relevant to personal circumstances (tailoring).. Direction to complete a tailored module is based on published cut off scores for the risk factor measure. Participants complete Stages of Change (5 items) pre- and post each module to measure readiness to change health behaviours related to the risk factor upon which the module is based. Participants complete ‘homework’ in-between modules (one 30 minute session per fortnight), which involves practicing the skills learned in the module and on return to the App report progress on a ‘landing page’ to complete the module before commencing the next one.
Intervention code [1] 296462 0
Prevention
Intervention code [2] 296476 0
Behaviour
Comparator / control treatment
HealthWatch is a web-based attention control program comprising of 12 interactive modules, each consisting of two components – an information module and a survey. Eight of the 12 modules and eight of the 12 surveys have been selected for use in the RCT based on relevance to the target age group. Participants are asked to choose four of the eight modules and four of the eight surveys most relevant to them. One module (15 minutes) and one survey (15 minutes) is completed as one 30 minute session per fortnight. . There is no homework in-between sessions.The HealthWatch content will be built into the app platform for the purposes of the trial. Topics of each module are relevant to wellbeing but contain no or minimal information about interventions for depression or stress. For example, the introduction to the humour topic commences with the explanation: "Some people believe that humour and laughter can prevent depression and increase the enjoyment of life. Today we would like to ask you to think about humour and whether it is important to your mood". The introduction is followed by a series of 16 multiple choice and open-ended questions: e.g., Do you enjoy telling jokes? (Responses: Yes, No, I can never remember any); How often do you tell jokes (Responses: Never, Rarely, about once a month, at least once a week, Most days); What is the funniest joke you can remember? (Open ended response); Overall do you think your moods are affected by humour? Data is collected in a web-based repository.

The lead investigator and co-investigator are able to monitor participant progress through the modules and surveys by logging in to the web-based platform underpinning the trial app as an editor. To manage adherence, an automated reminder system is programmed to allow participants to set times and dates to receive reminders at their convenience within required time periods..
Modules (15 minutes):
*Environmental health: A Personal Guide
Weight loss and nutrition
*Temperature extremes
*Calcium and vitamin D
*Bacteria and food borne illnesses
*Back pain
*Oral health
*Energise yourself
Surveys (15 minutes):
*Personal environmental health
*Sport
*Travel
*Humour
*Popular culture and movies
*Physical and mental activities
*Music and art
*Education
Control group
Active

Outcomes
Primary outcome [1] 300270 0
Intention to modify personal risk factors for depression and increased adoption of preventive strategies evidenced by significant positive change in mean Stages of Change scores towards 'Action' and ‘Maintenance’. (Composite outcome measure)
Timepoint [1] 300270 0
Baseline, 6 weeks, 3 months, 6 months, 12 months
Significant change is measured at the p<0.05 level of significance.
Primary outcome [2] 300271 0
Depression symptomatology measured by the Patient Health Questionnaire-9 (PHQ-9).
Significant change is measured at the p<0.05 level of significance
Timepoint [2] 300271 0
Baseline, immediately on completion of intervention or control program, 6 weeks, 3 months, 6 months, 12 months
Primary outcome [3] 300283 0
Change in resilience measured by the Child and Youth Resilience Measure (CYRM-12)
Significant change is measured at the p<0.05 level of significance
Timepoint [3] 300283 0
Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcome [1] 329563 0
Thinking style status measured by the Rumination Response Scale (RRS, 22 items)
Significant change is measured at the p<0.05 level of significance


Timepoint [1] 329563 0
Baseline, 6 weeks, 3 months, 6, months, 12 months
Secondary outcome [2] 329564 0
Coping style status measured by the brief COPE inventory (14 items).
Significant change is measured at the p<0.05 level of significance
Timepoint [2] 329564 0
Baseline, 6 weeks. 3 months. 6 months 12 months
Secondary outcome [3] 329565 0
Social connectedness measured by the social connection items from the Household, Income and Labour Dynamics in Australia (HILDA) (10 items),
Significant change is measured at the p<0.05 level of significance
Timepoint [3] 329565 0
Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcome [4] 329615 0
Alcohol use measured by the Adolescent Alcohol Involvement Scale (AAIS, 10 items)
Significant change is measured at the p<0.05 level of significance
Timepoint [4] 329615 0
Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcome [5] 329616 0
Cannabis use measured by the Adolescent Drug Involvement Scale (ADIS, 10 items)
Significant change is measured at the p<0.05 level of significance
Timepoint [5] 329616 0
Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcome [6] 329617 0
Depression literacy measured by the Adolescent Depression Knowledge Questionnaire (ADKQ).
Significant change is measured at the p<0.05 level of significance
Timepoint [6] 329617 0
Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcome [7] 329618 0
Perceived acceptability, utility and helpfulness of the intervention or control program measured by the Internet Evaluation and Utility Questionnaire (13 of 15 items) Composite outcome measure,
Significance is measured at the p<0.05 level of significance
Timepoint [7] 329618 0
Immediately on completion of intervention or control program
Secondary outcome [8] 329619 0
Perceived impact and effectiveness of the intervention or control measured by the Internet Impact and Effectiveness Questionnaire (6 of 19 items). Composite outcome measure,
Significance is measured at the p<0.05 level of significance
Timepoint [8] 329619 0
Immediately on completion of intervention or control program

Eligibility
Key inclusion criteria
*Aged 16 to 25 years
*Client of Aftercare-run headspace services
*Showing early signs of mental health issues but not meeting full DSM-V criteria for mental illness (as advised by headspace clinician).
*Ability to read and understand the English language
*Regular access to own iphone or android smart phone, email and internet.
*Willingness to provide name, email address and mobile number for risk management purposes and push notifications.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Age <16, >25 years
*Kessler10 score >35 at time of recruitment.
*As assessed by headspace clinician:
Current clinical episode of a mental illnesses.
Self-harm in previous month.
Suicidal attempt in previous month.
Psychotic features.

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 concealment at log in to app whereby participants do not know whether they have entered the intervention or the control
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
pre-programmed randomiser at log in
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Participants of the control group will be offered an opportunity to complete the intervention after the project is completed
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
MindExpress will be evaluated in SPSS (IBM Inc) by using a range of descriptive and multivariate statistical analyses. Longitudinal repeated measures MANOVA will be used to assess longitudinal change in primary and secondary outcomes. Independent. t tests will be used to assess differences in control and intervention effectiveness. Where combinations of influential variables are identified regression analyses will be used to identify the unique variance associated with different factors. Significance will be measured at the p = 0.05 level with minimum clinical effect size of Cohen’s d = 0.20.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
31/07/2018
Actual
Sample size
Target
256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295034 0
Charities/Societies/Foundations
Name [1] 295034 0
Ian Potter Foundation
Country [1] 295034 0
Australia
Funding source category [2] 295035 0
Charities/Societies/Foundations
Name [2] 295035 0
Aftercare
Country [2] 295035 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Botany Street,
Randwick,
NSW,
2025
Country
Australia
Secondary sponsor category [1] 293852 0
None
Name [1] 293852 0
Address [1] 293852 0
Country [1] 293852 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296386 0
University of New South Wales Higher Research Ethics Committee
Ethics committee address [1] 296386 0
Ethics committee country [1] 296386 0
Australia
Date submitted for ethics approval [1] 296386 0
26/10/2016
Approval date [1] 296386 0
Ethics approval number [1] 296386 0

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

Contacts
Principal investigator
Name 70678 0
Dr Alex Wilde
Address 70678 0
Aftercare, Level 2, Building 125 Church St (Cnr Glover St)
Rozelle Hospital Lilyfield NSW 2040
Country 70678 0
Australia
Phone 70678 0
+61 0409 607 125
Fax 70678 0
Email 70678 0
[email protected]
Contact person for public queries
Name 70679 0
Alex Wilde
Address 70679 0
Aftercare, Level 2, Building 125 Church St (Cnr Glover St)
Rozelle Hospital Lilyfield NSW 2040
Country 70679 0
Australia
Phone 70679 0
+61 409 607 125
Fax 70679 0
Email 70679 0
[email protected]
Contact person for scientific queries
Name 70680 0
Alex Wilde
Address 70680 0
Aftercare, Level 2, Building 125 Church St (Cnr Glover St)
Rozelle Hospital Lilyfield NSW 2040
Country 70680 0
Australia
Phone 70680 0
+61 409 607 125
Fax 70680 0
Email 70680 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.