ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Major Depression

Condition category

Condition code

Mental Health

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]

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]

Montgomery Asberg Depression Rating Scale

Timepoint [1]

End of treatment session five.

Secondary outcome [1]

Affective 2-back task accuracy and reaction time.

Timepoint [1]

End of session five.

Secondary outcome [2]

Skin conductance recordings: magnitude of skin conductance response and speed of habituation to affective stimuli.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Wellington Rd
Clayton, VIC
3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Ethics Committee

Ethics committee address [1]

Alfred Health Human Ethics Committee
Alfred Hospital
Commercial Rd
Prahran
3181 VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/12/2011

Ethics approval number [1]

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

Dr Rebecca Segrave

Address

Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran
VIC 3181

Country

Australia

Phone

+61 3 9076 5030

Fax

rebecca.segrave@monash.edu

Contact person for public queries

Name

Sara Arnold

Address

Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran
VIC 3181

Country

Australia

Phone

+61 3 9076 6592

Fax

sara.arnold@monash.edu

Contact person for scientific queries

Name

Rebecca Segrave

Address

Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Prahran
VIC 3181

Country

Australia

Phone

+61 3 9076 5030

Fax

rebecca.segrave@monash.edu

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

Source	Title	Year of Publication	DOI
Embase	Leveraging Neuroplasticity to Enhance Adaptive Learning: The Potential for Synergistic Somatic-Behavioral Treatment Combinations to Improve Clinical Outcomes in Depression.	2019	https://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.

Trial Review

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Documents added manually

Documents added automatically