Neurofeedback In Treatment Resistant Depression

Summary

The investigators evaluate the effects of neurofeedback as an augmentation treatment on depressive symptoms and functional recovery in patients with treatment-resistant depression (TRD).

TRD patients are assigned to the neurofeedback augmentation group and the medication-only (treatment as usual, TAU) group. The neurofeedback augmentation group underwent combined therapy comprising medication and 12-24 sessions of neurofeedback training for 12 weeks. To assess the serum levels of brain-derived neurotrophic factor (BDNF) in both groups, a pre- and post-treatment blood samples are obtained. Patients are evaluated using the Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory (BDI), Clinical Global Impression-Severity (CGI-S), 5-level version of European Quality of Life Questionnaire 5-Dimensional Classification (EQ-5D-5L), and Sheehan Disability Scale (SDS) at baseline, and at the 1-, 4-, and 12-week.

Conditions

• Depression
• Neurofeedback

Interventions

DEVICE

neurofeedback augmentation

Neurofeedback training was performed using a Neurocybernetics EEG Biofeedback system (Neurocybernetics Inc., Encino, CA, USA). The neurofeedback protocol was determined by the neurofeedback team, which included 3 psychiatrists, in consideration of the patient's main symptoms. The neurofeedback augmentation group was asked to participate in 12 weeks of combined therapy of medication and 12-24 sessions of neurofeedback training. Patients in the neurofeedback augmentation group received sensorimotor rhythm (SMR) beta or beta training for 30 minutes, and then alpha/theta (A/T) training for 30 minutes in each session. To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions. The medication-only (treatment as usual, TAU) group maintained the same medication use as that before the study.

DRUG

treatment as usual

The neurofeedback augmentation group and the medication-only group maintained the same medication use as that before the study.

OTHER

psychotherapy placebo sessions

To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions instead of neurofeedback training sessions. These sessions included psychological assessment and supportive psychotherapy.

Sponsors & Collaborators

• Yeungnam University Hospital

  lead OTHER

Principal Investigators

• Eun-Jin Cheon, M.D., Ph.D · Yeungnam University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-27

Primary Completion

2019-12-27

Completion

2020-02-08

Countries

• South Korea

Study Locations