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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT05314920
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 65, inclusive, who present to the PC centre seeking treatment for anxiety, depressive or somatic symptoms.
* Scores above the predetermined cut-off points on the GAD-7 (\>= 10), the PHQ-9 (\>= 10) or the PHQ-15 (\>=10 plus a score of 2 in three or more somatic symptoms).
* Agreement to participate in the study, with written informed consent.
Exclusion Criteria:
* Major depressive disorder (PHQ-9\> 24) and/or severe disability (SDS \> 25) will be interviewed by a clinician for the presence of any severe mental disorder, including autism spectrum disorders, bipolar disorder, schizophrenia, anorexia nervosa, substance dependence, personality disorder.
* Presence of severe or recent suicide attempts
* Presence of intellectual disability (IQ \< 70).
* Be receiving psychological treatment or any type of specialized care related to mental health.
* Insufficient Spanish language skills
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05314920
Study Brief:
Protocol Section:
NCT05314920