FMRI-neurofeedback in Depression

NCT05640089 | Recruiting

• 1 other identifier: NL72785.068.20
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction. The goal of this clinical trial is to compare fMRI-neurofeedback plus standard care with standard care in patients with depression. Participants will either receive standard care, or standard care plus a fMRI neurofeedback training, consisting of 5 neurofeedback training sessions. Symptom severity will be assessed before, immediately after and 6 months after the intervention.

Conditions

Depression, Unipolar

Keywords

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; fMRI Neurofeedback

Outcome Measures

Primary Outcomes (1)

• Post-intervention score for the 30 item Inventory of Depressive Symptomatology (IDS)

  30 item clinician rated depression scale (Rush et al., 1986; Rush, Gullion, Basco, Jarrett, \& Trivedi, 1996)

  End of intervention: appr. 2 months after baseline

Secondary Outcomes (12)

• Six month follow-up score for the 30 item Inventory of Depressive Symptomatology (IDS)

  6-month follow-up

• Post-intervention score for the Beck Depression Inventory (BDI)

  End of intervention: appr. 2 months after baseline

• Six month follow-up score for the Beck Depression Inventory (BDI)

  6-month follow-up

• Post-intervention score for the Hospital Anxiety and Depression Scale (HADS)

  End of intervention: appr. 2 months after baseline

• Six month follow-up score for the Hospital Anxiety and Depression Scale (HADS)

  6-month follow-up

Other Outcomes (4)

• Ability to self-regulate the target region-of-interest during neurofeedback training

  Each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)

• Changes in functional parameters (as measured by fMRI) of emotion networks over the course of the intervention

  Each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)

• Brain network activity during neurofeedback training (fMRI analysis)

  Each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)

Study Arms (2)

Emotion network up-regulation + standard care

EXPERIMENTAL

NF protocol targeting emotion networks (NFE) (plus standard care)

Other: fMRI-based neurofeedback

Standard care

NO INTERVENTION

Continuation of treatment as usual.

Interventions

fMRI-based neurofeedback OTHER

Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).

Emotion network up-regulation + standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a depressive disorder (ICD-10: F32 or F33)
• Has been on stable antidepressant medication (single or combination treatment) for at least 4 weeks
• Current depression (QIDS \>= 17)
• 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)

You may not qualify if:

• History of psychotic disorder bipolar disorder, or psychotic depression
• Current use of illegal drugs (any in the last four weeks)
• Current excessive alcohol consumption that interferes with daily functioning
• History of neurological disease that could influence the fMRI signal and/or the anatomical alignment (e.g. territorial stroke, multiple sclerosis, brain tumour)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (3)

Mondriaan Zorggroep

Maastricht, 6226NB, Netherlands

RECRUITING

Maastricht University

Maastricht, 6229ER, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, 6229HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression; Behavioral Symptoms; Mood Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David E Linden, Prof.

  Professor of Translational Neuroscience

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David E Linden, Prof.

CONTACT

+31 43 3881021; david.linden@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-02

Locations

NL (3)