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Trial registered on ANZCTR


Registration number
ACTRN12609000234213
Ethics application status
Approved
Date submitted
3/11/2008
Date registered
8/05/2009
Date last updated
5/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Self Efficacy: Better outcomes for youth with depressive disorders.
Scientific title
Does a cognitive-behavioural therapy treatment focussing on self-efficacy improve depression in adolescents?
Secondary ID [1] 280617 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unipolar depression 3917 0
Condition category
Condition code
Mental Health 4109 4109 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment involves 13 x 50 minute weekly sessions of cognitive-behavioural therapy with a self-efficacy focus. A dual clinician model is used where one clinician sees the young person and the other with their parent/guardian(s).A self-efficacy focussed cognitive-behavioural therapy (CBT) involves working with participant’s beliefs about their abilities to succeed in a number of domains including social, academic and self-regulation of mood and behaviour. To achieve this, the therapy will focus on introducing mastery experiences to the young person, the need for persistence and effort and, to limit rumination. Established CBT techniques will be used including psycho-education, relaxation training, communication skills training, problem solving skills training, cognitive restructuring, social skills training, life goals planning, pleasant events scheduling and relapse prevention. The young person will receive the therapy modules as discussed above while the parent, in a parallel session, will receive a separate program which overlaps to some degree with the young person’s therapy. However the focus will be on psycho-education on depression in adolescents, behavioural parenting strategies, communication, problem solving, and support for the parent. A benefit of the dual-clinician model is access to multiple sources of information regarding the psychological and behavioural functioning of the young person.
Intervention code [1] 3636 0
Behaviour
Comparator / control treatment
There is no control group, all participants receive the same treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5000 0
The Primary Outcome, depression diagnosis, will be measured with the Kiddie-Sads-Present and Lifetime Version (K-SADS-PL) Version 1.0 (Kaufman, Birmaher, Brent, Rao, & Ryan) 1996.
Timepoint [1] 5000 0
Assessment will take place at baseline (before treatment), immediately following 13 weekly sessions of treatment, and 6 months after the 13 weekly sessions of treatment.
Secondary outcome [1] 8443 0
Self-reported self-efficacy (The Self-Efficacy Questionnaire for Depressed Adolescents (SEQ-DA; Tonge et al 2005) The Self-Efficacy Questionnaire for Children (SEQ-C; Muris, 2001)
Timepoint [1] 8443 0
Assessment will take place at baseline (before treatment), immediately following 13 weekly sessions of treatment, and 6 months after the 13 weekly sessions of treatment.
Secondary outcome [2] 9224 0
Self-reported self-efficacy (The Self-Efficacy Questionnaire for Depressed Adolescents (SEQ-DA; Tonge et al 2005) The Self-Efficacy Questionnaire for Children (SEQ-C; Muris, 2001)
Timepoint [2] 9224 0
End of treatment and 6 months post-treatment
Secondary outcome [3] 9225 0
Depression: Reynolds Adolescent Depression Scale (RADS; Reynolds, 1986)
Timepoint [3] 9225 0
End of treatment and 6 months post-treatment
Secondary outcome [4] 9226 0
Suicidality Suicidal Ideation Questionnaire-Jr (SIQ-Jr; Reynolds, 1987)
Timepoint [4] 9226 0
End of treatment and 6 months post-treatment
Secondary outcome [5] 9227 0
Anxiety Revised Children?s Manifest Anxiety Scale (RCMAS; Reynolds & Richmond, 1978)
Timepoint [5] 9227 0
End of treatment and 6 months post treatment
Secondary outcome [6] 9228 0
Family functioning.
Family Assessment Device (FAD; Epstein et al 1983) - General Functioning Scale
Global Assessment of Relational Functioning (GARF, APA, 2000)
Timepoint [6] 9228 0
End of treatment and 6 months post treatment
Secondary outcome [7] 9229 0
Clinician related global functioning and improvement
Global Assessment of Functioning (GAF; APA, 2000)
Timepoint [7] 9229 0
End of treatment and 6 months post treatment
Secondary outcome [8] 9230 0
Sleep
Measured by Actigraphy
Epworth Sleepiness Scale
Stanford Sleepiness Scale
Timepoint [8] 9230 0
End of treatment and 6 months post treatment
Secondary outcome [9] 9370 0
Crying as assessed by the Adult Crying Inventory-17 modified (Whelan).
Timepoint [9] 9370 0
Assessment will take place at baseline (before treatment), immediately following 13 weekly sessions of treatment, and 6 months after the 13 weekly sessions of CBT
Secondary outcome [10] 241968 0
Self reported Self efficacy
Timepoint [10] 241968 0
Assessment will take place at baseline (before treatment), immediately following 13 weekly sessions of treatment, and 6 months after the 13 weekly sessions of treatment.

Eligibility
Key inclusion criteria
12 - 18 year olds who are experiencing a depressive disorder (either major depressive disorder, dysthymic disorder or depression not otherwise specified)
Minimum age
12 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include: major physical illness or epilepsy, bipolar disorder, organic brain syndrome, intellectual disability of sufficient severity to preclude participation in cognitive behavioural therapy, psychotic disorder, primary diagnosis of substance abuse disorder, active suicidality or other severe psychiatric disturbance that require acute hospital admission, and current antidepressant or psychotropic medication treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The Columbia Suicide Severity Rating Scale will be used to monitor suicidal ideation and behaviour at each appointment.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 4101 0
Government body
Name [1] 4101 0
beyondblue: the national depression initiative
Address [1] 4101 0
PO Box 6100
Hawthorn West VIC 3122
Country [1] 4101 0
Australia
Primary sponsor type
Government body
Name
beyondblue: the national depression initiative
Address
PO Box 6100
Hawthorn West VIC 3122
Country
Australia
Secondary sponsor category [1] 3692 0
None
Name [1] 3692 0
Address [1] 3692 0
Country [1] 3692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6172 0
Ethics committee address [1] 6172 0
Ethics committee country [1] 6172 0
Date submitted for ethics approval [1] 6172 0
05/11/2008
Approval date [1] 6172 0
Ethics approval number [1] 6172 0
Ethics committee name [2] 6588 0
Southern Health Human Research Ethics Committee
Ethics committee address [2] 6588 0
246 Clayton Rd., Clayton, Victoria, 3168
Ethics committee country [2] 6588 0
Australia
Date submitted for ethics approval [2] 6588 0
Approval date [2] 6588 0
30/01/2009
Ethics approval number [2] 6588 0
08204A

Summary
Brief summary
The purpose of this study is to test the feasibility of Self-Efficacy Focused Cognitive Behavioural Therapy (SEFCBT) for adolescents with depressive disorders and demonstrate that SEFCBT improves self-efficacy as well as depressive symptoms.
It is hypothesized that study participants receiving SEFCBT will experience significant reductions in depressive symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29088 0
Address 29088 0
Country 29088 0
Phone 29088 0
Fax 29088 0
Email 29088 0
Contact person for public queries
Name 12245 0
Dr. Glenn Melvin
Address 12245 0
Monash University
Building 1 / 270 Ferntree Gully Road
Notting Hill 3168 Victoria
Country 12245 0
Australia
Phone 12245 0
+61 3 9902.4562
Fax 12245 0
Email 12245 0
glenn.melvin@med.monash.edu.au
Contact person for scientific queries
Name 3173 0
Dr. Glenn Melvin
Address 3173 0
Monash University
Building 1 / 270 Ferntree Gully Road
Notting Hill 3168 Victoria
Country 3173 0
Australia
Phone 3173 0
+61 3 9902.4562
Fax 3173 0
Email 3173 0
glenn.melvin@med.monash.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary