Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000084785
Ethics application status
Approved
Date submitted
22/01/2013
Date registered
23/01/2013
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Date results provided
19/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive-reminiscence intervention for the alleviation of
depressive symptomatology in young adults
Scientific title
A randomised-controlled trial of cognitive-reminiscence therapy and treatment-as-usual for the alleviation of depressive symptomatology in young adults
Secondary ID [1] 281819 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 288168 0
Condition category
Condition code
Mental Health 288531 288531 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in six, 60-minute sessions of cognitive-reminiscence therapy. These sessions will be administered one-to-one and face-to-face by a psychologist, and held once weekly over a period of six weeks. This intervention is aimed at building skills in better understanding the self, others, and the world, and to improve problem-solving when faced with challenges. In this approach individuals learn cognitive reappraisal and problem-solving techniques to rationally and adaptively recall and reframe memories of themselves, others, and the world. Past experiences are discussed with a focus on remembering positive memories, and reframing and reinterpreting negative experiences. Continuity between one’s past and present is highlighted with a focus on rediscovering or rebuilding a sense of meaning in life. Active problem-solving strategies are also discussed in the context of individuals’ own personal experiences, and used to enhance self-efficacy, self-esteem, and coping. Individuals are taught to see their current difficulties in the context of past difficulties and apply this understanding to more adaptively cope with life stressors.
Intervention code [1] 286370 0
Treatment: Other
Comparator / control treatment
The comparative group will involve treatment-as-usual, whereby participants will receive intervention services as per the usual protocol at the youth mental health service to which they presented.
Control group
Active

Outcomes
Primary outcome [1] 288690 0
Depressive symptomatology, as measured by scores on the depression subscale of the short-form of the Depression, Anxiety, and Stress Scale
Timepoint [1] 288690 0
Baseline, and at three and six-weeks following the beginning of intervention, and one and three-month follow-ups.
Secondary outcome [1] 300767 0
Self-esteem as measured by the Rosenberg Self-Esteem Scale
Timepoint [1] 300767 0
Baseline, and at three and six-weeks following the beginning of intervention, and one and three-month follow-ups.
Secondary outcome [2] 300768 0
Self-efficacy, as measured by the New General Self-Efficacy Scale
Timepoint [2] 300768 0
Baseline, and at three and six-weeks following the beginning of intervention, and one and three-month follow-ups.
Secondary outcome [3] 300769 0
Meaning in Life, as measured by the Meaning in Life Questionnaire
Timepoint [3] 300769 0
Baseline, and at three and six-weeks following the beginning of intervention, and one and three-month follow-ups.

Eligibility
Key inclusion criteria
elevated levels of depressive symptomatology
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
currently receiving psychological treatment or psychopharmacological treatment for depression, physical health problems as cause of depression, psychotic symptoms, high suicide risk or high risk of harm to others, eating disorders, primary presenting issue around body image, diagnosable anxiety disorders, clinical manic symptoms, substance abuse or dependence as primary presenting issue, primary presenting issue of sexual disorder.

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)
Potential participants will be identified by the intake team at the participating youth mental health service during
intake assessments, on the basis of the inclusion and exclusion critieria. Once identified on this
basis, their suitability for inclusion in the project will be assessed more comprehensively by the clinical team
at the service. Once participants have been identified as suitable for recruitment, the individual will be offered participation from a case worker at the service and permission will be sought for a member of the research team to contact them. Once participants have agreed to participate and informed consent has been obtained, they will be randomised to either the intervention or treatment-as-usual condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once participants consent to participate they will be randomised by a third-party (not a member of the research team or youth mental health service) using a biased-coin approach with computer software. This bias-coin method will be used to preserve balance in groups due the small anticipated sample size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/01/2013
Date of last participant enrolment
Anticipated
Actual
5/03/2015
Date of last data collection
Anticipated
Actual
5/06/2015
Sample size
Target
60
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286604 0
University
Name [1] 286604 0
Deakin University
Country [1] 286604 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood. Victoria 3125
Country
Australia
Secondary sponsor category [1] 285391 0
None
Name [1] 285391 0
Address [1] 285391 0
Country [1] 285391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288678 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 288678 0
Ethics committee country [1] 288678 0
Australia
Date submitted for ethics approval [1] 288678 0
12/11/2012
Approval date [1] 288678 0
05/12/2012
Ethics approval number [1] 288678 0
2012-278

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

Contacts
Principal investigator
Name 37234 0
Prof David Mellor
Address 37234 0
Deakin University
221 Burwood Highway
Burwood VIC 3125
Country 37234 0
Australia
Phone 37234 0
+61 3 9244 3742
Fax 37234 0
Email 37234 0
[email protected]
Contact person for public queries
Name 37235 0
David Hallford
Address 37235 0
221 Burwood Highway
Burwood VIC 3125
Country 37235 0
Australia
Phone 37235 0
+61 3 9244 3042
Fax 37235 0
Email 37235 0
[email protected]
Contact person for scientific queries
Name 37236 0
David Hallford
Address 37236 0
221 Burwood Highway
Burwood VIC 3125
Country 37236 0
Australia
Phone 37236 0
+61 3 9244 3042
Fax 37236 0
Email 37236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.