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Trial registered on ANZCTR


Registration number
ACTRN12619001487101
Ethics application status
Approved
Date submitted
3/10/2019
Date registered
29/10/2019
Date last updated
29/10/2019
Date data sharing statement initially provided
29/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Depression with Neurofeedback training.
Scientific title
A controlled study to assess the therapeutic effects of neurofeedback training in depression.
Secondary ID [1] 295946 0
None.
Universal Trial Number (UTN)
U1111-1219-6373
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Depression 309449 0
Condition category
Condition code
Mental Health 308290 308290 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Name: Improving depression with neurofeedback training.

2. Why are we running the experimental trial?
We want to find out if neurofeedback training can reduce depression. We also want to know if a computer process called ‘machine learning’ can find new brain activity patterns linked to depression.

3. What does it involve?
Screening. We need a specific kind of person for the study. To decide if you fit our needs, you need to fill in an online screening form (please allow 20 minutes). This will ask you some questions: about the difficulties you are having; any help you have received; and about your mood, personality, physical health, age, gender, and contact details.

You can access the information sheet on the study here https:// otago/qualtrics.com/nfdep/screen.

After you have completed the form, we may invite you to a face-to-face interview (up to 1 hour) to confirm that you can take part in our experiment.

Part 1: If you are invited and agree to join our trial, you will attend a 1 hour and 15 minutes session. We will record brain activity from your scalp while you remain in a restful state with your eyes alternately open and closed for 10 minutes. You will also answer questions about your mood and personality on a computer. We will analyze the brain activity with machine learning.

Part 2: Next, you will attend 3 training sessions (up to 1 hour and 15 minutes) every week for three months (36 sessions in total) during which you will learn to use your mental activity to control a flat screen computer display. When your brain activity changes in a particular way, the display will change, in real time. This feedback will help you to learn to control your brain activity. Whenever your brain activity changes in the desired way, you will get a points reward in the computer game. Learning to change your brain activity like this is called ‘neurofeedback training’. You will also answer questions about your mood and well-being on a computer.

4.Who is running the trial?
The trial will be delivered by experienced brainwave researchers but will also include research assistants and students gaining experience in research as part of their study program.

5. How is the brain training trial run?
There are 36 sessions of brain training. You will be receiving training on two types of activity from your brain. Each session will provide feedback on one of two types of brainwave signal: an ‘active control’ and a ‘treatment’. We expect training with the active control to have neither good nor bad effects, and training with the ‘treatment’ to have good effects. Neither you nor the person testing you will be told which signal is being used when. This is called ‘double-blind’ testing.

6. What devices are involved?
Part 1 : For the machine learning session, we will record EEG using the EEGO amplifier from ANT Neuro. You will wear a waveguard cap from ANT Neuro. The cap is like a comfortable swimming cap with thirty over tiny sensors attached to it.

Part 2: For the neurofeedback training sessions, you will be fitted with the same type of EEG cap as above. EEG will be recorded from eight of the sensors with the BioRadio amplifier (Great Lakes Technology). EEG from some of these sensors control the neurofeedback stimuli that will be presented on a desk top computer screen.

7. Why are we using two different recording systems?
In part 1 of the study, our aim is to use machine learning techniques to identify EEG signals associated with depression. We hope to find EEG signals that can be used in brain training to relieve the symptoms of depression. Machine learning requires more data for its analyses. This is why we are using the EEGO amplifier, which allows us to recording EEG from a large number of scalp sites. For the same reason, we need a larger number of participants for part 1 of the study. We will separately recruit more participants for the machine learning part of the study.

8. How long is the 'wash out' period in the neurofeedback training experiment?
The 'wash out' period is between 1 to 5 days.
Intervention code [1] 312272 0
Treatment: Other
Comparator / control treatment
The comparator is a brainwave signal recorded from one of the scalp sites that is not known to be associated with depressive symptoms. This is preferred over a sham signal (pre-recorded display of changes in the feedback stimuli). The sham signal does not provide a relationship between the feedback and the mental activity and is more likely to be discovered by the volunteers.
Control group
Active

Outcomes
Primary outcome [1] 307263 0
Self-report changes in QIDS-SR scores.
Timepoint [1] 307263 0
Week 1, baseline.
Week 12, primary endpoint.
Participants fill out the QIDS-SR scores at the start of each of the 36 neurofeedback training sessions. Primary endpoint occurs at week 12.
Primary outcome [2] 307264 0
Changes in neurofeedback signals as assessed by EEG.
Timepoint [2] 307264 0
Week 1 session 1, baseline.
Week 12, primary endpoint.
EEG is recorded throughout the neurofeedback training task, in each of the 36 sessions. Primary endpoint occurs at week 12.
Secondary outcome [1] 376131 0
Self-report changes in QIDS-SR scores.
Timepoint [1] 376131 0
Week 4 and week 8
Secondary outcome [2] 376132 0
Changes in neurofeedback signals as assessed by EEG.
Timepoint [2] 376132 0
Week 4 and week 8

Eligibility
Key inclusion criteria
Inclusion criteria
- above 18 years old who are willing to try an experimental treatment.
- if already receiving help, the kind of help (e.g., doses, medicines and talking therapy) received needs to have been unchanged, for at least 6 weeks before and during the study so that we know reaction to it is stabilized.
- be able to come to all the study appointments

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
- has a mental illness besides major depressive disorder with or without comorbid anxiety disorder.
- is highly suicidal.
- has treatment-resistant depression.
- has current or past brain lesions.
- has a history drug abuse including drinking alcohol (more than 3 standard drinks per day or some alcohol everyday).
- uses antipsychotics, anxiolytics or mood stabilizers except if part of ongoing treatment for depression/anxiety
- suffers from serious physical disease such as heart and lung disease, influenza, diabetes and acute infections
- is recovering from an accident, injury or operation.
- has insufficient command of English or understanding of the study.
- has a history of seizures; susceptibility to photosensitivity; or a history of allergic skin reactions.
- is left-handed or ambidextrous.

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 is done by offsite staff and concealed from the onsite experimenters via steganography in binary files embedded in the computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Participants are assigned into two groups. Each group will consist of a minimum of 10 participants (after drop outs). This is based on the study by Peeters et al (2014) who achieved significance at P<0.05 or better with analyzed N=9.

Statistical significance will be tested with ANOVA. We will conduct trend analyses on symptom severity, control and treatment signals across individual sessions, and blocks within each group. These trends will also be compared across groups.

Peeters, F., et al., Neurofeedback As a Treatment for Major Depressive Disorder - A Pilot Study. Plos One, 2014. 9(3).

Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 20816 0
New Zealand
State/province [1] 20816 0
Dunedin

Funding & Sponsors
Funding source category [1] 300540 0
Charities/Societies/Foundations
Name [1] 300540 0
James Hume Bequest Fund
Address [1] 300540 0
496 Taieri Road
Dunedin 9010
Country [1] 300540 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street
North Dunedin
Dunedin 9016

Country
New Zealand
Secondary sponsor category [1] 304182 0
None
Name [1] 304182 0
Address [1] 304182 0
Country [1] 304182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301333 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 301333 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011

Ethics committee country [1] 301333 0
New Zealand
Date submitted for ethics approval [1] 301333 0
07/09/2018
Approval date [1] 301333 0
01/11/2018
Ethics approval number [1] 301333 0
18/CEN/170

Summary
Brief summary
Depression is a global health issue. Many patients do not respond to existing drug and/or talking therapies. This study will confirm if neurofeedback training with scalp recorded EEG improves symptoms of depression. We will also use machine learning techniques to identify new EEG signals optimized for brain training.

Before the start of brain training, volunteers will attend a session where we record their EEG while they are in a restful state. They will also fill in questionnaires that will ask them about their mood and personality on a computer. We will analyze the brain activity with machine learning. Volunteers who are able to commit to the brain training will move on to the next part of our study.

For the brain training part of our study, volunteers will attend 3 neurofeedback training sessions a week (up to 75 minutes), for 3 months. Neurofeedback training involves playing a computer game to use mental activity to control either a flat screen display or sounds. The display/sound changes, in real time, with changes in participants’ brainwaves. Such feedback helps the participants learn to regulate their mental activity. If the mental activity successfully changes the brainwaves in the desired direction (thought to relieve depressive symptoms), participants will be rewarded with points. No points are taken off for changes in the opposite direction.

We hypothesize that neurofeedback training to change brainwave activity in the desired direction will reduce the symptoms of depression.

The results of our neurofeedback study will increase the options for treating depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86654 0
Prof Paul Glue
Address 86654 0
PO Box 56
Dunedin 9054
New Zealand
University of Otago
Department of Psychological Medicine
Country 86654 0
New Zealand
Phone 86654 0
+64 3 470 9430
Fax 86654 0
Email 86654 0
paul.glue@otago.ac.nz
Contact person for public queries
Name 86655 0
Dr Phoebe Neo
Address 86655 0
PO Box 56
Dunedin 9054
New Zealand
University of Otago
Department of Psychology
Country 86655 0
New Zealand
Phone 86655 0
+64 3 479 5835
Fax 86655 0
Email 86655 0
phoebe.neo@otago.ac.nz
Contact person for scientific queries
Name 86656 0
Dr Phoebe Neo
Address 86656 0
PO Box 56
Dunedin 9054
New Zealand
University of Otago
Department of Psychology
Country 86656 0
New Zealand
Phone 86656 0
+64 3 479 5835
Fax 86656 0
Email 86656 0
phoebe.neo@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To see if EEG neurofeedback training really works to reduce depression, we need to look at the results averaged across people. A reduction, or the lack of it, in one person is not enough for us to conclude if neurofeedback training is effective or not, so we will not be making individual data available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results