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Trial registered on ANZCTR


Registration number
ACTRN12618000475246
Ethics application status
Approved
Date submitted
23/03/2018
Date registered
3/04/2018
Date last updated
19/03/2019
Date data sharing statement initially provided
19/03/2019
Date results information initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Acceptability and safety of a fact sheet for cognition in young people with depression.
Scientific title
Acceptability and safety of a fact sheet for cognition in young people with depression.
Secondary ID [1] 294419 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 307158 0
Condition category
Condition code
Mental Health 306275 306275 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study examining the acceptability and safety of a fact sheet about cognitive symptoms for young people (15-25 years) with depression. All participants will be recruited from a single specialist treatment clinic for young people with a major depressive disorder. Consenting participants will be seen for an initial (baseline) assessment and then given access to the cognition fact sheet (intervention) by their case manager at the mood clinic. Case managers will guide the young person through the fact sheet. It will be delivered in a one-to-one format. The fact sheet is a 2-sided A4 page, with information about cognitive functioning difficulties observed in depression, how they affect functioning and factors that can affect cognition. The flip-side of the fact sheet contains tips and strategies for managing cognitive difficulties, including attention, learning and memory, planning and organisation and completing complex tasks. Participants will be invited to attend second (follow-up) assessment approximately 2 weeks after first receiving the fact sheet. Each baseline and follow-up assessment will be approximately 40 minutes duration.
Intervention code [1] 300712 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305279 0
Acceptability of the cognition fact sheet measured using the "Participant Acceptability and Safety questionnaire" and "Case Manager Acceptability and Safety questionnaire" both designed specifically for this study.
Timepoint [1] 305279 0
Assessed at post-intervention only (approximately 2 weeks after receiving the intervention).
Primary outcome [2] 305349 0
Safety of the cognition fact sheet measured using the "Participant Acceptability and Safety questionnaire" and "Case Manager Acceptability and Safety questionnaire" both designed specifically for this study.
Timepoint [2] 305349 0
Assessed at post-intervention only (approximately 2 weeks after receiving the intervention).
Secondary outcome [1] 344686 0
Self-reported cognitive functioning measured using the "Neuropsychological Symptom Self-report (NSSR)" and "Perceived Deficits Questionnaire (PDQ)".
Timepoint [1] 344686 0
Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
Secondary outcome [2] 344687 0
Cognition awareness and confidence measured using the "Cognition awareness, confidence and strategy use questionnaire" designed specifically for the study.
Timepoint [2] 344687 0
Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
Secondary outcome [3] 344699 0
Self-reported depression measured using the "Patient Health Questionnaire-9 (PHQ-9)"
Timepoint [3] 344699 0
Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
Secondary outcome [4] 344700 0
Self-esteem measured using the "Rosenberg Self-Esteem Scale (RSES)"
Timepoint [4] 344700 0
Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
Secondary outcome [5] 344701 0
Self-efficacy measured using the "General self-efficacy scale "
Timepoint [5] 344701 0
Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
Secondary outcome [6] 344934 0
Cognition strategy use measured using the "Cognition awareness, confidence and strategy use questionnaire" designed specifically for the study.
Timepoint [6] 344934 0
Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).

Eligibility
Key inclusion criteria
- Aged 15-25 years old inclusive.
- Receiving treatment in the Orygen Youth Mood Clinic.
- Diagnosis of a major depressive disorder according to DSM-V (current or past).
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cannot read or speak English fluently.
- Diagnosis of Bipolar Disorder



Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
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
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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)
VIC
Recruitment hospital [1] 10466 0
Orygen Youth Health - Parkville
Recruitment hospital [2] 10471 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment postcode(s) [1] 22175 0
3052 - Parkville
Recruitment postcode(s) [2] 22180 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 299048 0
Other
Name [1] 299048 0
Orygen, The National Centre of Excellence in Youth Mental Health
Address [1] 299048 0
35 Poplar Rd, Parkville VIC 3052
Country [1] 299048 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre of Excellence in Youth Mental Heath
Address
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 298283 0
None
Name [1] 298283 0
Address [1] 298283 0
Country [1] 298283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299983 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299983 0
Level 2
South West
300 Grattan Street
Parkville Victoria 3052
Ethics committee country [1] 299983 0
Australia
Date submitted for ethics approval [1] 299983 0
20/02/2018
Approval date [1] 299983 0
05/04/2018
Ethics approval number [1] 299983 0

Summary
Brief summary
Peak onset for depression occurs during adolescence and young adulthood, with one in five young people experiencing a clinical depressive episode by the age of 18. Both objective and subjective cognitive difficulties such as poor concentration and memory are features of depression in young people. Cognitive difficulties in depression contribute to everyday functioning difficulties. Managing cognitive issues is therefore an important part of treatment. One potentially useful method of providing information on, and strategies for management of cognitive difficulties, is through fact sheet provision during routine clinical care. Nevertheless, it is currently unclear whether fact sheets are an acceptable and safe method of providing information about cognition to young people with depression, or whether this has the potential to be useful for increasing awareness and self-management strategies. The aim of this study is to investigate the acceptability, safety and potential effectiveness of a cognition fact sheet for young people receiving treatment for depression. If found to be acceptable, safe and potentially useful, the utility of a fact sheet could be further explored in a larger trial with a controlled comparison group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82158 0
Dr Kelly Allott
Address 82158 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, Parkville VIC 3052
Country 82158 0
Australia
Phone 82158 0
+61393422942
Fax 82158 0
Email 82158 0
kelly.allott@orygen.org.au
Contact person for public queries
Name 82159 0
Dr Kelly Allott
Address 82159 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, Parkville VIC 3052
Country 82159 0
Australia
Phone 82159 0
+61393422942
Fax 82159 0
Email 82159 0
kelly.allott@orygen.org.au
Contact person for scientific queries
Name 82160 0
Dr Kelly Allott
Address 82160 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, Parkville VIC 3052
Country 82160 0
Australia
Phone 82160 0
+61393422942
Fax 82160 0
Email 82160 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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary