Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000080527
Ethics application status
Approved
Date submitted
13/01/2015
Date registered
30/01/2015
Date last updated
15/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive control training for treatment resistant depression: application, evaluation and augmentation
Scientific title
Cognitive control training for treatment resistant depression: application, evaluation and augmentation
Secondary ID [1] 285938 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depression 293866 0
Condition category
Condition code
Mental Health 294171 294171 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is trialling a new behavioural therapy called Cognitive Control Training (CCT). CCT involves repeated practice of targeted cognitive activities that are specifically designed to activate areas of the brain that allow us to control and direct our attention. This study is additionally investigating whether the effectiveness of CCT can be further enhanced using a form of mild brain stimulation called transcranial direct current stimulation (tDCS). tDCS is a safe, non-invasive, painless technique which has the capacity to temporarily alter cortical excitability. In this study it is delivered to the dorsolateral prefrontal cortex.

Participants will be randomised to one of the following four conditions and receive a 25 minute intervention session on fifteen consecutive week days:

(a) 25-minutes of CCT and active tDCS (2 mA)
(b) 25-minutes of CCT and sham tDCS (tDCS that we believe will have no effect)
(c) 25-minutes of a different cognitive training and active tDCS (2 mA)
(d) 25-minutes of a different cognitive training and sham tDCS

Stimulation and cognitive training are administered simultaneously. They will be administered by a trained research staff member. Participants will not be informed which condition they have been allocated to until the end of the study.
Intervention code [1] 290916 0
Treatment: Other
Intervention code [2] 291074 0
Treatment: Devices
Comparator / control treatment
There is a placebo condition in place. The placebo involves 25-minutes of a different cognitive training and sham tDCS Participants initially randomised to the placebo condition will be given the opportunity to be re-randomised to the active intervention upon completion of the sham controlled phase.
Control group
Placebo

Outcomes
Primary outcome [1] 293964 0
The Montgomery Asberg Depression Rating Scale will be used as a primary outcome measure for depression severity.
Timepoint [1] 293964 0
Baseline, 1 week and 3 weeks after intervention commencement, and 2 months post-intervention.
Secondary outcome [1] 312243 0
The 2-back working memory task will be used as a secondary outcome measure of cognitive control.
Timepoint [1] 312243 0
Baseline, 1 week and 3 weeks after intervention commencement, and 2 month post-intervention.

Eligibility
Key inclusion criteria
1. Are voluntary and able to provide full informed consent,
2. Are currently in the midst of a Major Depressive Episode as confirmed by structured diagnostic interview with the Mini-International Interview for DSM-IV,
3. Are between the ages of 18 and 65 years.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a DSM-IV history of substance abuse or dependence in the last 6-months,
2. Have a concomitant major and/or unstable medical or neurologic illness;
3. Are currently taking carbamazepine or benzodiazepines,
4. Are currently pregnant or lactating,
5. Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws and clips from surgical procedures

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)
Allocation occurs via central randomised computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised via a computer generated randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2013
Actual
8/08/2013
Date of last participant enrolment
Anticipated
Actual
15/01/2016
Date of last data collection
Anticipated
Actual
6/04/2016
Sample size
Target
80
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290532 0
Charities/Societies/Foundations
Name [1] 290532 0
beyondblue
Country [1] 290532 0
Australia
Funding source category [2] 290533 0
University
Name [2] 290533 0
Monash University
Country [2] 290533 0
Australia
Funding source category [3] 293479 0
Charities/Societies/Foundations
Name [3] 293479 0
Sir Edward Dunlop Medical Research Foundation
Country [3] 293479 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 289226 0
None
Name [1] 289226 0
Address [1] 289226 0
Country [1] 289226 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294922 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 294922 0
Ethics committee country [1] 294922 0
Australia
Date submitted for ethics approval [1] 294922 0
28/02/2013
Approval date [1] 294922 0
04/02/2013
Ethics approval number [1] 294922 0
26/13

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

Contacts
Principal investigator
Name 53910 0
Dr Rebecca Segrave
Address 53910 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, VIC, 3004
Country 53910 0
Australia
Phone 53910 0
+61 3 9076 5030
Fax 53910 0
Email 53910 0
[email protected]
Contact person for public queries
Name 53911 0
Cassandra Thomson
Address 53911 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, VIC, 3004
Country 53911 0
Australia
Phone 53911 0
+61 3 9076 6592
Fax 53911 0
Email 53911 0
[email protected]
Contact person for scientific queries
Name 53912 0
Rebecca Segrave
Address 53912 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran, VIC, 3004
Country 53912 0
Australia
Phone 53912 0
+61 3 9076 5030
Fax 53912 0
Email 53912 0
[email protected]

No information has been provided regarding IPD availability


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.