Skip to content

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

Real-time fMRI-based adaptive amygdala neurofeedback using dynamic human facial stimuli to target affective biases in depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71745131
Enrollment
22
Registered
2022-11-01
Start date
2021-08-19
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Patients diagnosed with mild to moderate unipolar depression (major depressive disorder, MDD) Mental and Behavioural Disorders

Interventions

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 clini
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 tra

Sponsors

University of Zurich
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

Exclusion criteria: 1. Relevant Axis-1disorders: F0 (organic disorders), F1 (alcohol, opioids, etc), F2 (psychotic disorders), bipolar disorder, prominent F4 disorders (i.e., PTSD, Panic disorder), main diagnosis F6 (particularly emotionally unstable personality disorder), known F7 disorder. 2. Neurological comorbidities such as epilepsy, stroke, brain tumor, and traumatic brain injury based on the MINI Neuropsychiatric assessment. 3. Patients on antipsychotics, benzodiazepines, medications such as Temesta (>1-2 mg/day), Methadon or Haloperidol except for SSRI antidepressants. 4. Alcohol, nicotine, or other substance dependence per DSM-IV criteria. 5. MRI contraindications such as pregnancy, lactation, brain surgery, or metallic implants.

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Switzerland

Contacts

Public ContactApurva Watve
apurva.watve@uzh.ch+41 583842667

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026