NeuroMooD – Neurofeedback in depression

• Register: ISRCTN
• Last refreshed on: 22 August 2022
• Main ID: ISRCTN10526888
• Date of registration: 09/02/2016
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: NeuroMooD – Neurofeedback in depression
• Scientific title: FMRI neurofeedback treatment of self-blaming emotions in major depressive disorder – a pilot trial
• Date of first enrolment: 01/09/2016
• Target sample size: 45
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN10526888
• Study type: Interventional
• Study design: Randomised controlled clinical proof-of-concept trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Roland Zahn

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Partially remitted major depressive disorder (MDD)
Mental and Behavioural Disorders
Partially remitted major depressive disorder (MDD)

Intervention(s)

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

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

N/A

Source(s) of Monetary Support

King’s College London

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/09/2018