Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07388004
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-80 years
* Current diagnosis of major depressive disorder (MDD) according to DSM-5, confirmed by structured clinical interview (e.g., DIPS)
* Hamilton Depression Rating Scale (HAMD-21) score ≥ 9
* Ability to attend group therapy sessions (2×/week for 5 weeks)
* Ability to undergo MRI scanning (for participants in the fMRI component) Written informed consent
Exclusion Criteria:
* Current or lifetime diagnosis of bipolar disorder, psychotic disorder, or primary substance use disorder
* High acute suicide risk requiring immediate intervention
* Severe neurological disorder, brain injury, or contraindications for MRI (e.g., metal implants, claustrophobia)
* Ongoing psychotherapy or initiation of a new antidepressant medication within the past 4 weeks
* Insufficient German language proficiency to participate in therapy and complete study assessments
* Cognitive impairment or other conditions interfering with informed consent or study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07388004
Study Brief:
Protocol Section:
NCT07388004