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:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT04328103
Eligibility Criteria:
Inclusion Criteria:
* aged 18-65
* right-handed
* be able to speak English well enough to comprehend and comply with protocol requirements
* recruited to achieve equal gender representation (i.e. about half male) in both treatment arms
* medically healthy individuals will be included as MDD patients if they:
1. meet DSM-5 criteria for a current MDD episode based on a structured clinical interview (SCID);
2. score greater or equal to 13 on the Beck Depression Inventory (BDI-II)
3. score greater or equal to 14 on the Hamilton Rating Scale for Depression (HRSD)
Exclusion Criteria:
* Participants are excluded for any of the following reasons or DSM-5 criteria:
1. substance abuse or dependence (including alcohol) in last 6 months;
2. positive toxicology screen as determined by blood/urine testing (e.g. thyroid dysfunction, street drug use);
3. history of schizophrenia or other current psychotic disorder;
4. MDD with psychotic or catatonic features;
5. Bipolar I, II Affective Disorder;
6. Organic Mental Disease;
7. significant suicidal ideation with a plan and intent, also assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), that cannot be managed safely as an outpatient, or homicidal ideation (suicidality monitored throughout study);
8. a primary diagnosis of panic disorder, obsessive-compulsive disorder, psychogenic pain disorder, anorexia/bulimia, or any unstable medical condition;
9. any recent (less than or equal to 12 mos) history of CBT (as determined during an in-person interview);
10. prior seizure disorder, significant head trauma or other neurological disorders;
11. lack of capacity to give informed consent;
12. received psychotropic medication, over-the-counter antidepressant, or any non-CBT intervention (e.g. deep breathing, meditation/mindfulness, psychotherapy - except for minimal supportive nonspecific therapy PBO) for at least 1 month prior to recruitment (3 months for fluexetine);
13. hearing loss (\>30 dB in either ear) or hearing asymmetry (\>10 dB across ears) assessed via standard audiogram
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04328103
Study Brief:
Protocol Section:
NCT04328103