A randomised controlled trial of fMRI-neurofeedback in depressio

Recruiting

Conditions: Affective Disorder
Depression
10027946

Registration Number: NL-OMON54250

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. Diagnosis of a depressive disorder (ICD-10: F32 or F33)
2. Has been on stable antidepressant medication (single or combination
treat-ment) for at least 4 weeks
3. Currently depression (QIDS >= 17)
4. 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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>IDS (Inventory of Depressive Symptomatology) scores at post-intervention<br /><br>between groups</p><br>

Secondary Outcome Measures

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