Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000050752
Ethics application status
Approved
Date submitted
18/12/2012
Date registered
15/01/2013
Date last updated
15/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive control training for major depression: application, evaluation and augmentation.
Scientific title
Can concurrent transcranial direct current stimulation augment the antidepressant efficacy of cognitive control training for major depression?
Secondary ID [1] 281775 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 287982 0
Condition category
Condition code
Mental Health 288365 288365 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants engage in five treatment sessions on consequent week days. Each session comprises cognitive training coupled with active or sham transcranial direct current stimulation (tDCS). Specifically, participants are randomised to one of the following intervention conditions:

a) cognitive control training + anodal tDCS (2mA)
b) cognitive control training + sham tDCS
c) peripheral vision training + anodal tDCS (2mA)

Cognitive control training comprises a set of computerised thinking tasks designed to engage the dorsolateral prefrontal cortex region of the brain. The peripheral vision training comprises a set of computerised thinking tasks designed to engage the visual cortex to a great degree than the dorsolateral prefrontal cortex.

Both types of training will be administered concurrently with active/sham tDCS throughout five 24-minute treatment sessions.
Intervention code [1] 286231 0
Treatment: Other
Comparator / control treatment
The following two condition's are for comparison purposes:

b) cognitive control training + 24 minutes sham (inactive) tDCS
c) peripheral vision training + 24 minutes anodal tDCS (2mA)
Control group
Active

Outcomes
Primary outcome [1] 288537 0
Montgomery Asberg Depression Rating Scale
Timepoint [1] 288537 0
End of treatment session five.
Secondary outcome [1] 300402 0
Affective 2-back task accuracy and reaction time.
Timepoint [1] 300402 0
End of session five.
Secondary outcome [2] 300403 0
Skin conductance recordings: magnitude of skin conductance response and speed of habituation to affective stimuli.
Timepoint [2] 300403 0
End of session five.

Eligibility
Key inclusion criteria
1. Are voluntary and competent to consent,
2. Are currently in the midst of a DSM-IV defined Major Depressive Episode.
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 defined history of bipolar disorder, psychotic illness, obsessive compulsive disorder or substance abuse or dependence in the last 6-months,
2. Have a history of traumatic brain injury or neurologic illness,
3. Are currently taking carbamazepine or benzodiazepines,
4. Are currently pregnant or lactating.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2012
Actual
25/07/2012
Date of last participant enrolment
Anticipated
Actual
28/06/2013
Date of last data collection
Anticipated
Actual
28/06/2013
Sample size
Target
45
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286483 0
University
Name [1] 286483 0
Monash University
Country [1] 286483 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Alfred Psychiatry Research Centre
607 St Kilda Rd
Prahran
3181 VIC
Country
Australia
Secondary sponsor category [1] 285274 0
None
Name [1] 285274 0
Address [1] 285274 0
Country [1] 285274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288559 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 288559 0
Alfred Health Human Ethics Committee
Alfred Hospital
Commercial Rd
Prahran
3181 VIC
Ethics committee country [1] 288559 0
Australia
Date submitted for ethics approval [1] 288559 0
Approval date [1] 288559 0
23/12/2011
Ethics approval number [1] 288559 0
475/11

Summary
Brief summary
Many depressed individuals fail to respond to available pharmacological and psychological therapies and there is a significant need to develop novel antidepressant treatment approaches. Traditionally, both research into and treatment approaches for depression have focused on the emotional disturbance associated with this illness. However, depression also disrupts cognitive processing. There is now considerable evidence indicating that the cognitive and emotional symptoms of depression interact with each other (e.g. causing an individual to remember more negative memories, or to pay more attention to negative thoughts and stimuli), and these interactions directly contribute to the length and severity of depressive episodes.

Recently it has been suggested that targeting the cognitive symptoms of depression may also help to improve emotional dysfunction. One way that this could be achieved via cognitive control training (CCT). CCT simply involves a small number of thinking activities that an individual repeatedly practices to improve their ability to sustain and focus their attention and to self-direct their thought processes.

The cognitive processes that CCT aims to enhance are largely subsumed by a frontal region of the brain called the dorsolateral prefrontal cortex. Research has shown that a mild form of brain stimulation called transcranial direct current stimulation (tDCS) administered to this brain region can enhance cognitive processing. As such, tDCS may be a useful means of augmenting the efficacy of CCT for depression.
Trial website
Trial related presentations / publications
Segrave RA et al. Concurrent cognitive control training augments the antidepressant efficacy of tDCS. A pilot study. Brain Stim, 7(2), 325 -331.
Public notes

Contacts
Principal investigator
Name 36682 0
Dr Rebecca Segrave
Address 36682 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran
VIC 3181
Country 36682 0
Australia
Phone 36682 0
+61 3 9076 5030
Fax 36682 0
Email 36682 0
[email protected]
Contact person for public queries
Name 36683 0
Ms Sara Arnold
Address 36683 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran
VIC 3181
Country 36683 0
Australia
Phone 36683 0
+61 3 9076 6592
Fax 36683 0
Email 36683 0
[email protected]
Contact person for scientific queries
Name 36684 0
Dr Rebecca Segrave
Address 36684 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran
VIC 3181
Country 36684 0
Australia
Phone 36684 0
+61 3 9076 5030
Fax 36684 0
Email 36684 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
SourceTitleYear of PublicationDOI
EmbaseLeveraging Neuroplasticity to Enhance Adaptive Learning: The Potential for Synergistic Somatic-Behavioral Treatment Combinations to Improve Clinical Outcomes in Depression.2019https://dx.doi.org/10.1016/j.biopsych.2018.09.004
N.B. These documents automatically identified may not have been verified by the study sponsor.