The main objective of this pilot-study is to examine the effectiveness of NF in the treatment of major depression.
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Quick Inventory of Depressive Symptoms (QIDS)
- Hamilton Depression Rating Scale (HDRS)
- decrease of alpha-asymmetry
Secondary outcome
- Positive and Negative Affect Schedule (PANAS)
- Temporal Experience of Pleasure Scale (TEPS)
- Heartrate variability
Background summary
Major depressive disorder is a high-prevalent psychiatric disorder. Despite
current available treatments, primarily pharmacotherapy and psychotherapy,
partial remission and treatment resistance are common. Moreover,
pharmacotherapy is associated with a number of undesirable side-effects.
Apparently, there is quite some room for improvement. Neurofeedback (NF) for
the treatment of depression has received increased attention in recent years.
Within an operant paradigm, patients are connected to an EEG device that helps
them, after analysis of brain-activity, to change brainactivity in certain
areas. Feedback is given with a visual stimulus based on real-time analysis of
the EEG.
Although there are widespread claims about its effectiveness, there is no
scientific evidence that support these claims. No studies into the
effectiveness have been carried out. There is some evidence from fundamental
research into the neurophysiology of depression that NF may be helpfull indeed.
Additionally, heart-rate variability (HV) appears to decreased in depression.
In this study, an ECG will be made prior and after NF treatment to investigate
whether NF is associated with increase in HV.
Study objective
The main objective of this pilot-study is to examine the effectiveness of NF in
the treatment of major depression.
Study design
The current study is a open pilot-study in 10 depressed (according to the
criteria of DSM-IV) patients.
Intervention
Participants will be treated with a maximum of 30 NF sessions in a frequency of
3 sessions each week. The maximum study duration in each participant will be 10
weeks. NF will be done on the basis of an alpha-asymmetry protocol. In this
protocol, participants will learn through operant conditioning to decrease
alpha-activity in left prefrontal regions and to increase alpha-activity in
right prefrontal regions.
Study burden and risks
Neurofeedback sessions and filling-out self-report instruments do not
constitute a burden or risk for the participants.
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
major depressive episode
Exclusion criteria
- history of brain trauma
- current use of antipsychotics, moodstabilisers, or benzodiazepines. current use of antidepressants is allowed if type and dosage are not changed during the study
- chronic depression (>2 years)
- dysthymia
- bipolar disorder
- lefthandedness
- severe depression or suicidality (HDRS >25)
- pregnancy
- other comorbid axis 1 disorders other than anxiety disorders or a personality disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL25291.068.08 |
OMON | NL-OMON26159 |