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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT01080105
Eligibility Criteria:
Inclusion Criteria:
* PredictD Risk Score of .130
* Has a telephone, e-mail account, computer, and broadband access to the Internet.
* Is able to speak and read English.
* Is at least 19 years of age.
* Is able to give informed consent.
Exclusion Criteria:
* Has DSM-IV diagnosis of Major Depressive Episode assessed using the MINI
* Has hearing or voice impairment that would prevent participation in psychotherapy.
* Has visual impairment that would prevent use of the workbook and completion of assessment materials.
* Meets criteria for dementia by scoring \< 25 on the Telephone Interview for Cognitive Status (TICS).
* Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous. Patients with substance abuse diagnoses who have been clean and sober for 3 months will be admitted if otherwise eligible.
* Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 12-week treatment phase of the study.
* Is planning to be out of town or unavailable for treatment for 4 weeks or more during the scheduled treatment time.
* Exhibits severe suicidality, including ideation, plan, and intent.
* Has initiated treatment with an antidepressant in past 10 days. Once patients have been on a stable dose for 10 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01080105
Study Brief:
Protocol Section:
NCT01080105