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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT02938559
Eligibility Criteria:
Inclusion Criteria:
* Age 18+ years
* Willing and able to give full consent
* English language fluency
* Diagnosis of major depressive disorder (MDD), first episode, recurrent or chronic, according to DSM-5
* Minimum score 26 or above on the Inventory of Depressive Symptomatology, Self-Report (IDS-SR). This cutoff denotes at least 'moderate' depression
* If taking medications for mood, medications must be stable for the past four weeks
Exclusion Criteria:
* History of Bipolar Disorder
* History of Psychosis or psychotic features
* Lifetime history of failure to respond to 4 or more sessions of CBT/CT for depression
* Current non-psychotic disorder if it constitutes the principal diagnosis and if it requires treatment other than that offered in the project. 'Principal' is defined as the disorder currently most distressing and disabling, using a widely accepted severity rating scale capturing distress and interference (0-8, 4+ indicates clinical severity)
* Moderate or severe substance use in the past 6 months where 'moderate' is defined as 4-5 symptoms and 'severe' is defined as 6+ listed in DSM-5 for each of the substance-related disorders
* Evidence of any medical disorder or condition that could cause depression, preclude participation in CT, or is associated with memory problems, that is not currently stabilized and/or managed under the care of a physician or the presence of an active and progressive physical illness or neurological degenerative disease,
* Current suicide risk sufficient to preclude treatment on an outpatient basis (assessed by the Columbia-Suicide Severity Rating Scale) or current homicide risk (assessed by our staff, a case manager or psychiatrist)
* Pregnancy or breastfeeding
* Not able/willing to participate in and/or complete the pre-treatment assessments
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02938559
Study Brief:
Protocol Section:
NCT02938559