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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT04647318
Eligibility Criteria:
Inclusion Criteria:
* Being ≥18 years old
* A clinical level of depression or anxiety (defined as ≥ 8 on the ODSIS14 or OASIS15)
* High self-criticism or low self-reassurance, as measured by the FSCRS16 (≥24 on self-inadequacy, ≥ 8 on self-hatred, or ≤18 on self-reassurance). These cut-offs correspond to 0.5 SD above the mean in self-inadequacy/self-hatred, and 0.5 SD below the mean on self-reassurance, based on a validation of the FSCRS17 in Colombia28.
Exclusion Criteria (Note: these were added subsequent to seeking ethical approval but before study commencement):
* Positive screen on the Mood Disorder Questionnaire (MDQ), following the norms published by the authors
* Positive screen on the Standardised Assessment of Personality - Abbreviated Scale (SAPAS), defined as scoring 4+
* Severity of Dependence Scale (SDS): scoring 3+ for alcohol use or 5+ for other substances.
* Significant suicidal ideation. Participants were asked, "On a scale of 1 to 7, what is your intent to end your life right now?" from 1 (low) to 7 (high), and "Are you uncertain about being able to control suicidal impulses?" (Yes/No). Participants were excluded for responding ≥5 on item 1 or "yes" to item 2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04647318
Study Brief:
Protocol Section:
NCT04647318