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A randomised controlled trial of fMRI-neurofeedback in depression

A randomised controlled trial of fMRI-neurofeedback in depression - FMRI-neurofeedback in depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54250
Enrollment
120
Registered
2020-02-28
Start date
2021-04-29
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affective Disorder Depression

Interventions

Patients of the neurofeedback group take part in five neurofeedback sessions (four weekly sessions and one session four weeks after the fourth session). The fMRI-NF sessions will include anatomical

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of a depressive disorder (ICD-10: F32 or F33)  2. Currently depression (QIDS >= 17) 3. If required to meet recruitment targets the minimum entry score will be  reduced QIDS >= 13 (i.e. still corresponding to a moderate level of depression)

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for MRI (e.g. cardiac pacemaker, certain metallic  implants) 2. History of psychotic disorder bipolar disorder, or psychotic depression 3. Current use of illegal drugs (any in the last four weeks) 4. Current excessive alcohol consumption that interferes with daily functioning 5. History of neurological disease that could influence the fMRI signal and/or  the ana-tomical alignment (e.g. territorial stroke, multiple sclerosis, brain  tumour)6. Scoring a 3 on item 12 of the QIDS (‘thoughts of suicide’), while not currently in treatment (those falling under this category will be advised to contact their GP or other clinical professional to seek clinical help in the first instance).

Design outcomes

Primary

MeasureTime frame
IDS (Inventory of Depressive Symptomatology) scores at post-intervention between groups

Secondary

MeasureTime frame
1. Scores at post-intervention between groups for: BDI (Beck Depression Inventory) HADS (Hospital Anxiety and Depression Scale) SES (Self Efficacy Scale) QoL (Quality Of Life scale) EQ-5D-5L (EuroQol research foundation questionnaire) PsyMate depression questions 2. Scores after each neurofeedback session in Profile of Mood States (POMS) 3. Neurofeedback performance 4. Changes in brain structure / activation over time 5. Correlations between neurofeedback performance and the other measures at baseline, during the training and post intervention

Countries

Netherlands

Contacts

Public ContactDEJ Linden

Universiteit Maastricht

david.linden@maastrichtuniversity.nl+3143 3881021

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)