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Trial registered on ANZCTR


Registration number
ACTRN12619000712101
Ethics application status
Approved
Date submitted
7/05/2019
Date registered
13/05/2019
Date last updated
23/08/2021
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
App-based brain training for young people with depression
Scientific title
App-based cognitive training for young people with depression: A pilot randomised controlled trial
Secondary ID [1] 298147 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Youth depression 312692 0
Condition category
Condition code
Mental Health 311192 311192 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aims of this study are to examine the acceptability and safety of app-based cognitive training as well as the potential benefits of training on objective cognitive outcomes for young people with depression, when compared with an active control.

The primary intervention is a commercially available cognitive training smartphone app. This involves playing interactive 'game-like' cognitive exercises, which engage a range of cognitive domains including attention/vigilance, processing speed, learning and memory, and various executive functions (e.g. inhibition and flexibility). There is recent evidence to support improvements in untrained domain-specific cognitive tasks following intensive training using this app (i.e. 15 minute training sessions five times per week over 10 weeks) when compared to an active computer game control condition. Adherence will be monitored using software built into the app, with utilisation reports for each participant sent to the research team monthly.

Participants that are randomly allocated to this intervention will train on the app individually on at least 4 separate days per week (at least 15 minutes per occasion) over the 8-week intervention duration. Participants will guide their own training program and select their own training exercises. All participants will receive a weekly reminder text to encourage app use. This intervention protocol was informed via focus groups with young people with mental health concerns. All participants will be asked to attend a baseline assessment, start-up meeting (to provide the participant's app allocation and set up a user account, representing the start of the intervention) and post-intervention assessment.
Intervention code [1] 314370 0
Treatment: Other
Intervention code [2] 314443 0
Treatment: Devices
Comparator / control treatment
The control condition in this study is a commercially available gratitude diary app. This app allows participants to log multiple daily personalised 'gratitudes' (i.e. record the people, places, experiences, etc, that the person is thankful for in their life). The app includes various features to increase user participation and motivation, including uploading photos, affirmations (i.e. quotes that are shown daily) and a calendar-tracking function. Similar to the intervention group, control participants will be asked to use the app on at least 4 separate days per week over the 8-week intervention duration and will receive a weekly text to encourage app use. This condition is designed to control for non-specific factors such as increased screen time on, and structured engagement with, health-related apps.
Control group
Active

Outcomes
Primary outcome [1] 319950 0
Acceptability of app-based cognitive training as measured using the "Participant Acceptability and Safety questionnaire" that was designed specifically for this study (adapted from a previous trial: ACTRN12618000475246)
Timepoint [1] 319950 0
Assessed at post-intervention only (i.e. week 9-10; 1-2 weeks post intervention),
Primary outcome [2] 319951 0
Change in objective cognitive functioning measured using the global composite generated from the Orygen harmonised cognitive battery (i.e. Rey Auditory Verbal Learning Test, Symbol Digit Modalities Test, Penn Emotion Recognition Task, and Cogstate tasks: Detection Task, Identification Task, One-Back and Two-Back Task and Gronton Maze Learning Task).
Timepoint [2] 319951 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [1] 369970 0
Change in subjective cognitive functioning measured using the Neuropsychological Symptom Self-Report (NSSR).
Timepoint [1] 369970 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [2] 369971 0
Change in cognitive awareness, confidence and strategy use measured using the "Cognition awareness, confidence and strategy use questionnaire" that was designed specifically for this study (adapted from a previous trial: ACTRN12618000475246)
Timepoint [2] 369971 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [3] 369972 0
Change in everyday community functioning measured using the Social and Occupational Functioning Scale (SOFAS)
Timepoint [3] 369972 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [4] 369973 0
Change in pychological distress measured using the Kessler Psychological Distress Scale (K10).
Timepoint [4] 369973 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [5] 369974 0
Change in self-efficacy measured using the General Self-Efficacy Scale (GSE)
Timepoint [5] 369974 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [6] 369975 0
Change in self-esteem using the Rosenberg Self-Esteem Scale (RSES).
Timepoint [6] 369975 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [7] 369976 0
Change in gratitude levels using the Gratitude Questionnaire (GQ6)
Timepoint [7] 369976 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [8] 369977 0
Change in quality of life measured using the Assessment of Quality of Life (AQOL-8D).
Timepoint [8] 369977 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [9] 369978 0
Change in depression symptoms measured using the Patient Health Questionnaire (PHQ-9)
Timepoint [9] 369978 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).
Secondary outcome [10] 370310 0
Change in subjective cognitive functioning measured using the Perceived Deficits Questionnaire (PDQ).
Timepoint [10] 370310 0
Administered at baseline (i.e. week 0, prior to randomisation) and post-intervention (i.e. week 9-10; 1-2 weeks post intervention).

Eligibility
Key inclusion criteria
1. Aged 12-25 years old inclusive.
2. Diagnosis of a current major depressive disorder or persistent depressive disorder (dysthymia) according to DSM-V.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cannot read or speak English fluently.
2. Diagnosis of bipolar or psychosis-spectrum disorder.
3. History of neurological injury or disease significantly impacting cognition.
4. Documented history of intellectual disability.
5. Documented history of substance dependence.
6. Pronounced sensorimotor impairment with the potential to significantly impact intervention engagement.
7. No regular access to smartphone to engage with the program.
8. Participant has used a cognitive training or gratitude diary app in the last 3 months.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
27/05/2019
Actual
13/08/2019
Date of last participant enrolment
Anticipated
Actual
23/01/2020
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302672 0
Charities/Societies/Foundations
Name [1] 302672 0
Perpetual (IMPACT philanthropic grant)
Country [1] 302672 0
Australia
Funding source category [2] 302675 0
University
Name [2] 302675 0
University of Melbourne
Country [2] 302675 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre of Excellence of Youth Mental Health
Address
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 302604 0
University
Name [1] 302604 0
University of Melbourne
Address [1] 302604 0
Parkville VIC 3010
Country [1] 302604 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303295 0
University of Melbourne, Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 303295 0
Ethics committee country [1] 303295 0
Australia
Date submitted for ethics approval [1] 303295 0
Approval date [1] 303295 0
09/10/2018
Ethics approval number [1] 303295 0

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

Contacts
Principal investigator
Name 93170 0
Dr Kelly Allott
Address 93170 0
Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville VIC 3052
Country 93170 0
Australia
Phone 93170 0
+61 3 9966 9100
Fax 93170 0
Email 93170 0
Kelly.Allott@orygen.org.au
Contact person for public queries
Name 93171 0
Kelly Allott
Address 93171 0
Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville VIC 3052
Country 93171 0
Australia
Phone 93171 0
+61 3 9966 9100
Fax 93171 0
Email 93171 0
Kelly.Allott@orygen.org.au
Contact person for scientific queries
Name 93172 0
Kelly Allott
Address 93172 0
Orygen, The National Centre of Excellence in Youth Mental Health, 35 Poplar Rd, Parkville VIC 3052
Country 93172 0
Australia
Phone 93172 0
+61 3 9966 9100
Fax 93172 0
Email 93172 0
Kelly.Allott@orygen.org.au

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.