Condition category
Mental and Behavioural Disorders
Date applied
07/12/2015
Date assigned
09/02/2016
Last edited
08/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Depression is one of the most common mental disorders worldwide. The symptoms of depression can vary greatly from person to person, but generally include low mood, problems with sleeping and/or eating, and loss of interest in life. Depression comes in many forms however the most recognised is major depressive disorder (MDD). People suffering from MDD tend to go through periods where they are able to function normally (remittance) and depressive episodes, in which the feelings of depression begin suddenly, lasting for at least two weeks and are serious enough to affect day to day life. Even effective treatments, such as talking therapy and medication, do not guarantee complete remittance in patients with MDD. A possible reason may be that partly remitted patients still experience feelings of “self-blame”, which can lead to further depressive episodes. There is therefore an urgent need to better understand the role self-blame plays in remitted patients and to develop new treatments that improve long-term outcomes of MDD. Previous studies using functional magnetic resonance imaging (fMRI), a type of brain scan which shows what is happening in the brain in real time, suggest that this may be because certain parts of the brain do not function as they should do in patients with MDD. A technique called fMRI-neurofeedback has been developed which works by highlighting abnormal brain activity and teaching a patient how to change it by giving them feedback. The aim of this study is to compare the effects of fMRI-neurofeedback and a new psychological treatment program on reducing self-blame in adults suffering from MDD.

Who can participate?
Right handed adults with MDD who haven't responded well enough to a standard treatment for a depressive episode.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group are given a self-guided psychological (mental health) therapy designed to reduce self-blame and increase self-worth. Participants in the second group a have the fMRI neurofeedback treatment as well as the self-guided therapy. At the start of the study and the end of the study, participants in both groups complete a number of questionnaires in order to find out if there has been any improvement in their mood and self-esteem, and if their levels of self-blame have been reduced.

What are the possible benefits and risks of participating?
There are no direct benefits to participants taking part in the study. The FMRI neurofeedback and the psychological therapy are non-invasive procedures which are considered safe, and so risks of taking part in the study are minimal.

Where is the study run from?
Kings College London (UK)

When is the study starting and how long is it expected to run for?
June 2015 to September 2018

Who is funding the study?
Kings College London (UK)

Who is the main contact?
Dr Roland Zahn

Trial website

http://www.kcl.ac.uk/ioppn/depts/pm/research/CfAD/NeuroMooDStudy.aspx

Contact information

Type

Public

Primary contact

Dr Roland Zahn

ORCID ID

http://orcid.org/0000-0002-8447-1453

Contact details

Institute of Psychiatry
Psychology & Neuroscience
King's College London
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

FMRI neurofeedback treatment of self-blaming emotions in major depressive disorder – a pilot trial

Acronym

NeuroMooD

Study hypothesis

Patients undergoing active transcranial direct current stimulation (tDCS) or active neurofeedback (ATL-subgenual - correlation decrease) will show reduced depressive symptoms, decreased self-blame and increased self-worth.

Ethics approval

NRES Committee London-Camberwell St Giles, 11/06/2015, ref: 15/LO/0577

Study design

Randomised controlled clinical proof-of-concept trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Partially remitted major depressive disorder (MDD)

Intervention

Interventions as of 08/08/2016:
Participants are randomised to two treatment arms which all include 3 treatment sessions:

Arm 1: Psychological self-guided intervention to reduce self-blame and increase self-worth

Arm 2: Anterior temporal lobe-posterior subgenual cingulate correlation fMRI neurofeedback + psychological self-guided intervention to reduce self-blame and increase self-worth

The study involves 5 visits: Pre-trial assessment on visit 1 (day 0), treatment session 1 (visit 2) taking place 1-13 days after visit 1, treatment session 2 (visit 3) taking place 7-13 days after visit 2, treatment session 3 (visit 4) taking place 7-13 days of Visit 3 and the post-trial assessment on visit 5 taking place 7-13 days after the last treatment visit.


Original interventions:
Participants are randomised to three treatment arms which all include 3 treatment sessions:

Arm 1: Right anterior temporal lobe cathodal transcranial Direct Current Stimulation (tDCS) + psychological self-guided intervention to reduce self-blame and increase self-worth

Arm 2: Sham (mock) right anterior temporal lobe tDCS + psychological self-guided intervention to reduce self-blame and increase self-worth

Arm 3: Anterior temporal lobe-posterior subgenual cingulate correlation fMRI neurofeedback + psychological self-guided intervention to reduce self-blame and increase self-worth

The study involves 5 visits: Pre-trial assessment on visit 1 (day 0), treatment session 1 (visit 2) taking place 1-13 days after visit 1, treatment session 2 (visit 3) taking place 7-13 days after visit 2, treatment session 3 (visit 4) taking place 7-13 days of Visit 3 and the post-trial assessment on visit 5 taking place 7-13 days after the last treatment visit.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Depressive symptoms are assessed using the Beck Depressive Inventory (BDI-II) at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit).

Secondary outcome measures

1. Depressive symptoms are assessed using the Montgomery–Asberg Depression Rating Scale (MADRS) at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
2. Self-rated depressive symptoms are assessed using the Quick Inventory of Depressive Symptomatology (QIDS-SR 16) at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
3. Self-rated depressive symptoms are assessed using the Clinical Global Impression Scale at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
4. Withdrawal rates and adverse events are recorded continuously throughout the trial
5. ATL-SCSR correlation in the neurofeedback arm is measured using fMRI and compared between the first and last treatment session (at the start of visit 2 and at the end of visit 4 or at the start and end of visit 1 for patients lost to follow-up, and at the start of visit 2 and the end of visit 3 for patients with missing data from visit 4)
6. Self-contempt bias is assessed using the Brief Implicit Association Test (BIAT) at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
7. Self-esteem is assessed using the Rosenberg Self Esteem Scale at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
8. Changes in mood states are assessed using the Profile of Mood States (POMS) Scale at baseline (Visit 1) and at visit 5 (7-13 days of last treatment visit)
9. Self-blame ratings are obtained using the Moral Emotion Addendum to the AMDP as the sum of all self-blaming emotion scores at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
10. Agency-incongruent self-blame is measured using the short version of the value-related moral sentiment task at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)
11. Clinical global impression is self- & observer rated using the Global Social Functioning Score at baseline (visit 1) and at visit 5 (7-13 days of last treatment visit)

Overall trial start date

11/06/2015

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Recurrent major depressive disorder (MDD) according to DSM-V with at least one major depressive episode (MDE) of at least 2 months duration, insufficiently remitted from current MDE and stable symptoms for at least 6 weeks, level of symptoms that are significantly bothering or impairing
2. If treated with antidepressants, on stable dose for at least 6 weeks prior participation and planning to stay on this dose for the duration of the study
3. Patients have insufficiently responded to at least one course of cognitive behavioural therapy (CBT) or antidepressants or are not amenable to these standard treatments and are not currently undergoing psychotherapy
4. Aged 18 years or over
5. Right-handedness
6. Proficient in English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

Exclusion criteria as of 08/08/2016:
1. Greater than low risk of suicidality or violence
2. Current MDE with a duration of more than one year
3. Prior specialist diagnosis of ADHD, antisocial or borderline personality disorder
4. Standard MRI contraindications such as exclusion of participants with any kind of non-removable ferromagnetic devices or implants due to possible dangerous effects of the MRI magnet upon metal objects in the body
5. History of learning disabilities or developmental disorders
6. Impairments of vision or hearing which cannot be corrected during the experiment
7. History of manic or hypomanic episodes, of schizophreniform symptoms or schizophrenia, of substance abuse, neurological disorders such as seizures, loss of consciousness following brain injury or medical disorders affecting brain function, blood flow or metabolism
8. Current intake of benzodiazepines, GABAergic or benzodiazepine receptor agonists
9. Current recreational drug use
10. Pregnancy

Original exclusion criteria:
1. Active suicidal thoughts or history of suicide attempts or aggression
2. Last MDE with a duration of more than one year
3. Prior specialist diagnosis of ADHD, antisocial or borderline personality disorder
4. Standard MRI and tDCS contraindications such as exclusion of participants with any kind of non-removable ferromagnetic devices or implants due to possible dangerous effects of the MRI magnet upon metal objects in the body
5. History of learning disabilities or developmental disorders
6. Impairments of vision or hearing which cannot be corrected during the experiment
7. History of manic or hypomanic episodes, of schizophreniform symptoms or schizophrenia, of substance abuse, neurological disorders such as seizures, loss of consciousness following brain injury or medical disorders affecting brain function, blood flow or metabolism
8. Current intake of benzodiazepines, GABAergic or benzodiazepine receptor agonists, psychostimulants (e.g. Ritalin, and Adderall), or seizure provoking medication (e.g. Bupropion and Theophylline)
9. History of electroconvulsive therapy (ECT)
10. Current recreational drug use
11. Pregnancy

Recruitment start date

01/09/2016

Recruitment end date

01/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
Institute of Psychiatry Psychology & Neuroscience 16 De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

King’s College London

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication of study results in peer reviewed journal within 1 year of trial end date.

Intention to publish date

30/09/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/08/2016: The study methodology has been revised. The following changes have been made to the study record: 1. The overall trial end date has been updated from 30/09/2017 to 30/09/2018 2. The interventions have been updated to include two study arms rather than three 3. The titles have been updated (originally both "Comparing fMRI neurofeedback and neurostimulation treatments of self-blaming emotions in major depressive disorder" 4. The participant exclusion criteria has been updated 5. The recruitment dates have been updated from 04/01/2016 - 31/05/2017 to 01/09/2016 - 0109/2018