Improving emotion regulation in depression using real-time fMRI-based neurofeedback

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: The researchers employed a pseudo‐randomization method in which patients were alternately assigned to the two experimental groups. The study involves five visits. Visit 1 (day 0): pre‐training clinical and MRI assessment; Visit 2 (day 1): neurofeedback training session 1; Visit 3 (day 2): neurofeedback training session 2; Visit 4 (day 3): post‐training clinical and MRI assessment and Visit 5 (day 56): follow‐ up assessments similar as the fourth visit. MDD patients perform eight neurofeedback runs spread across two training sessions (four runs/session) on two consecutive days (Visits 2 and 3). Patients are briefed about the amygdala feedback and asked to try to change the emotional expression of the dynamically changing facial stimuli. The change in the valence of the emotional face is linked to the patient’s ongoing amygdala activity. Each training run consisted of the two alternatively arranged happy‐up and fear‐down regulation blocks. In the ‘Happy‐up’ condition, patients are asked to make the presented neutral facial stimulus happier through amygdala upregulation by using mental strategies of their choice. In the ‘Fear‐down’ condition, they are instructed to reduce the fearfulness of the facial stimulus to neutral by downregulating amygdala activity using relevant mental strategies. To control for non‐specific training effects, each training run has alternative experimental and sham conditions. In the experimental condition, the continuously updated feedback as changing intensity of the facial expression reflects the patient’s ongoing amygdala activity. In the sham condition, the feedback is generated based on the patient’s performance in the preceding experimental c CONDITION: Patients diagnosed with mild to moderate unipolar depression (major depressive disorder, MDD) ; Mental and Behavioural Disorders PRIMARY OUTCOME: Depressive symptoms measured using clinician administered 21‐item Hamilton Depression Rating Scale (HAMD‐21) and the Montgomery‐Asberg Depression Rating Scale (MADRS) at pre‐training (visit 1), post‐training (visit 4) and follow‐up (visit 5). INCLUSION CRITERIA: 1. Right‐handed adults (18 ‐ 65 years of age) with normal vision. 2. Primary diagnosis of unipolar depression based on DSM‐IV. 3. Currently in a depressive episode with/without stable SSRI antidepressant medication or oral contraceptives and with/without co‐morbid anxiety. 4. Fluent in German without any intellectual deficits (basic education completed). SECONDARY OUTCOME: ; 1. Positive and negative affectivity measured using the self‐rated Snaith‐Hamilton Pleasure Scale for Depression (SHAPS‐D) and State and Trait Anxiety Inventory (STAI), respectively, at pre‐, post‐training and follow‐up.; 2. Self‐control and self‐efficacy assessment performed using the self‐rated Competence and Control Beliefs Questionnaire (FKK) at pre‐, post‐training and follow‐up.; 3. Mood states measured using the Multidimensional Mood State Questionnaire (MDBF) at pre‐, post‐training and follow‐up.; 4. Valence and arousal ratings of happy, fearful and neutral facial stimuli measured by the face rating task at pre‐, post‐training and follow‐up.; 5. Patients’ amygdala activity measured in response to the happy, fearful, and neutral facial stimuli in the pre‐ and post‐training transfer tasks.; 6. Patients’ amygdala activity measured in response to the happy, fearful, and neutral facial stimuli using dynamic emotion matching task at pre‐, post‐training and follow‐up.; 7. Resting‐state functional connectivity measured at pre‐, post‐training and follow‐up.;
Epistemonikos ID: a0a01c19088144c22a3c8c42e252ec1a515c8e2b
First added on: Aug 26, 2024