FMRI-neurofeedback in Depression
ConditionDepression, Unipolar
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Exclusion criteria for MRI (e.g. cardiac pacemaker, certain metallic implants)
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
Trial design
Design model
Parallel
Treatments tested in this trial
fMRI-based neurofeedback
Other interventionParticipants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Emotion network up-regulation + standard careExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
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)
Time frame
End of intervention: appr. 2 months after baselineSecondary outcomes
1
Six month follow-up 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)
Time frame
6-month follow-up2
Post-intervention score for the Beck Depression Inventory (BDI)
Self-rated depression scale (Beck, Steer, \& Brown, 1996)
Time frame
End of intervention: appr. 2 months after baseline3
Six month follow-up score for the Beck Depression Inventory (BDI)
Self-rated depression scale (Beck, Steer, \& Brown, 1996)
Time frame
6-month follow-up4
Post-intervention score for the Hospital Anxiety and Depression Scale (HADS)
Self-rated depression and anxiety scale (Zigmond \& Snaith, 1983). The questionnaire comprises 7 questions for anxiety and 7 for depression. Each scale has a minumum score of 0 and a maximum score of 21. A higher score means more severe anxiety- or depression complaints.
Time frame
End of intervention: appr. 2 months after baselineOther outcomes
1
Ability to self-regulate the target region-of-interest during neurofeedback training
Determine whether participants are able to modulate their BOLD activity in keeping with the neurofeedback
Time frame
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)2
Changes in functional parameters (as measured by fMRI) of emotion networks over the course of the intervention
Analysis of fMRI data
Time frame
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)3
Brain network activity during neurofeedback training (fMRI analysis)
Determining changes in brain networks (e.g. default mode network)
Time frame
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)4
Changes in Profile of Mood States (POMS) after neurofeedback sessions
Measure to address any imminent changes in mood state
Time frame
Before and after 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)Sponsors and contacts
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Source ClinicalTrials.gov