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Neurofeedback for Depression

A randomized controlled trial into the efficacy of neurofeedback for treatment of major depressive disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24001
Enrollment
50
Registered
2014-09-17
Start date
2014-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Depression, major depression

Interventions

After signing informed consent, participants will be invited to the neurofeedback laboratory of the school for Mental Health and Neuroscience (MheNS). This laboratory is a facility that meets the requ
. At the start of each NF session, the baseline EEG is being measures without NF to assess baseline AA which serves as a starting point for feedback. Measuring baseline prior to each session is neces

Sponsors

Prof. Dr. F.P.M.L. Peeters Afdeling Psychiatrie Academisch Ziekenhuis Maastricht Postbus 5800 6202 AZ Maastricht Tel : 043-3874130 Fax : 043-3875444 E-mail: f.peeters@maastrichtuniversity.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Primary axis-1 disorder of Major Depressive Disorder fulfilling DSM-IV criteria [14]. The diagnosis will be based on resuls from the Structured Interview for DSM-IV [15], that is an element of the diagnostic work-up at the RIAGG Maastricht. • Written informed consent.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • History of brain trauma (commotio or constusio cerebri) or CVA. • Current use of antipsychotics, moodstabilizers or benzodiazepines. Current use of antidepressants is permitted if this medication is not changed within a period of 6 weeks prior to participation in the study. Additionally, no changes in antidepressant medication are allowed during active participation in the study. • Chronic depression (> two years duration). • Dysthymia as a primary axis-1 diagnosis • Bipolar disorder or schizophrenia as a primary axis-1 diagnosis • Severe suicidality (HDRS item # 3 with a score >2) or severe depression symptomatology (HDRS score > 25). • Pregnancy. • Age 65 years. • Daily alcoholintake of >7 units.

Design outcomes

Primary

MeasureTime frame
Depression severity as assessed with the Quick Inventory of Depressive Symptoms (QIDS-SR; [18], and the Hamilton Depression Rating Scale (HDRS; [19]. •The QIDS-SR is a 16-item self-rating scale to assess symptom severity of MDD and will be administered prior to each NF session (3 times a week). •The HDRS is a 17-item clinician-rated scale for estimating severity of depression during the past week. It will be administered once a week by a trained research assistant during the 6-week study period.

Secondary

MeasureTime frame
Remission from Depression Questionnaire (RDQ; [20] and change in AA between frontal cortical regions. • The RDQ is a 41-item self-rating scale that measures symptomatic and functional remission from depression. It will be administrated once a week during the 6-week study period. • AA in frontal regions (F3-F4) will be calculated as described in the intervention paragraph above. Other study parameters • Demographical data-sheet (date of birth, gender, educational level, marital status). • The State-Trait Anxiety Inventory (STAI). This instrument measures state and trait anxiety based on 40 items [21]. • General health before and after the treatment will be measured with the RAND-36. Based on 36 items, various dimensions of general health are being measured [22]. • After their last NF-session, participants will be asked to indicate whether, in their opinion, they have received active or sham-treatment. • Questionnaire “Classificatie van links- en rechtshandige proefpersonen” [23].

Contacts

Public ContactF.P.M.L. Peeters

Department of Psychiatry University Hospital Maastricht P.O. Box 5800

f.peeters@maastrichtuniversity.nl043-3874130

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)