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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT06432959
Eligibility Criteria:
Clinic-specific inclusion criteria are as follows. For the clinic providing CBT for depression, participants must meet criteria for a diagnosis of major depressive disorder according to Diagnostic and Statistical Manual-5 (DSM-5). They must also be able to attend in-person sessions or have access to a reliable internet connection to participate in virtual sessions.
For the clinic providing DBT, participants must evidence severe emotion dysregulation defined as (1) meeting criteria for borderline personality disorder (BPD) or (2) elevated indicators of borderline personality pathology defined as average scores of 1.5 on the Personality Inventory for DSM-5 (PID-5) Negative Affectivity scale and 1.25 on the Antagonism scale and/or 1.25 on the Disinhibition scale. They must also be willing and able to attend in-person sessions.
Across both clinics, the following inclusion and exclusion criteria will be applied:
Inclusion Criteria:
1. 18 years old or older
2. residence in the state of Ohio
3. able and willing to give informed consent
Exclusion Criteria:
1. current or past diagnosis of bipolar disorder or a psychotic disorder
2. presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening)
3. currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
4. if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks
5. clear indication of secondary gain (e.g., court-ordered treatment)
6. current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06432959
Study Brief:
Protocol Section:
NCT06432959