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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT04039568
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years of age;
2. 2\. Significant depressive symptomology (PHQ-9 score ≥10);
3. Chronic pain (pain ≥3 months duration in any body region, by self-report);
4. Be willing and able to attend all 4 training sessions of SSM/HEP and 75% of follow-up sessions;
5. Understanding of English language (spoken and written);
6. Able to sit for 20-25 minutes without significant discomfort;
7. Regular access to internet and ability to participate in video calls
Exclusion Criteria:
1. Other major psychiatric conditions including substance use disorder, psychosis and cognitive impairment as excluded by the Mini-International Neuropsychiatric Interview (MINI) Screening and Standard tool; severe depression (PHQ-9 ≥20) and risk of imminent suicide as per MINI and/or PHQ-9;
2. Non-correctable, clinically significant sensory impairment;
3. Acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months;
4. A terminal medical diagnosis with prognosis of less than 12 months;
5. Currently practising any form of mind-body intervention;
6. Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04039568
Study Brief:
Protocol Section:
NCT04039568