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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
26/02/2020
Date data sharing statement initially provided
19/03/2019
Date results provided
26/02/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Acceptability and safety of a fact sheet for cognition in young people with depression.
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Scientific title
Acceptability and safety of a fact sheet for cognition in young people with depression.
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Secondary ID [1]
294419
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Condition category
Condition code
Mental Health
306275
306275
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0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
300712
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Treatment: Other
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Assessed at post-intervention only (approximately 2 weeks after receiving the intervention).
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Assessed at post-intervention only (approximately 2 weeks after receiving the intervention).
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Secondary outcome [1]
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Self-reported cognitive functioning measured using the "Neuropsychological Symptom Self-report (NSSR)" and "Perceived Deficits Questionnaire (PDQ)".
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Assessment method [1]
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Timepoint [1]
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Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
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Secondary outcome [2]
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Cognition awareness and confidence measured using the "Cognition awareness, confidence and strategy use questionnaire" designed specifically for the study.
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Assessment method [2]
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Timepoint [2]
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Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
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Secondary outcome [3]
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Self-reported depression measured using the "Patient Health Questionnaire-9 (PHQ-9)"
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Assessment method [3]
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Timepoint [3]
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Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
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Secondary outcome [4]
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Self-esteem measured using the "Rosenberg Self-Esteem Scale (RSES)"
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Assessment method [4]
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Timepoint [4]
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Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
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Secondary outcome [5]
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Self-efficacy measured using the "General self-efficacy scale "
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Assessment method [5]
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Timepoint [5]
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Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
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Secondary outcome [6]
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Cognition strategy use measured using the "Cognition awareness, confidence and strategy use questionnaire" designed specifically for the study.
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Assessment method [6]
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Timepoint [6]
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Assessed at baseline (prior to the intervention) and post-intervention (approximately 2 weeks after receiving the intervention).
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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).
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Minimum age
15
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Cannot read or speak English fluently.
- Diagnosis of Bipolar Disorder
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
16/04/2018
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Actual
16/04/2018
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Date of last participant enrolment
Anticipated
16/10/2018
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Actual
12/03/2019
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Date of last data collection
Anticipated
1/04/2019
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Actual
1/04/2019
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Sample size
Target
25
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Orygen Youth Health - Parkville
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Recruitment hospital [2]
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Orygen Youth Health - Sunshine - Sunshine
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Recruitment postcode(s) [1]
22175
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3052 - Parkville
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Recruitment postcode(s) [2]
22180
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3020 - Sunshine
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Funding & Sponsors
Funding source category [1]
299048
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Other
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Name [1]
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Orygen, The National Centre of Excellence in Youth Mental Health
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Address [1]
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35 Poplar Rd, Parkville VIC 3052
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Country [1]
299048
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Australia
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Primary sponsor type
Other
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Name
Orygen, The National Centre of Excellence in Youth Mental Heath
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Address
35 Poplar Rd, Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
298283
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Address [1]
298283
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Country [1]
298283
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299983
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
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Level 2 South West 300 Grattan Street Parkville Victoria 3052
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Ethics committee country [1]
299983
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Australia
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Date submitted for ethics approval [1]
299983
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20/02/2018
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Approval date [1]
299983
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05/04/2018
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Ethics approval number [1]
299983
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kelly Allott
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Address
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Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, Parkville VIC 3052
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Country
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Australia
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Phone
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+61393422942
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Kelly Allott
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Address
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Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, Parkville VIC 3052
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Country
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Australia
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Phone
82159
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+61393422942
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Fax
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Email
82159
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[email protected]
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Contact person for scientific queries
Name
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Kelly Allott
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Address
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Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Rd, Parkville VIC 3052
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Country
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Australia
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Phone
82160
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+61393422942
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Fax
82160
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Email
82160
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
Acceptability, safety and perceived impact of providing a fact sheet to young people about cognitive symptoms in depression.
2021
https://dx.doi.org/10.1111/eip.12945
N.B. These documents automatically identified may not have been verified by the study sponsor.
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