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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03653351
Eligibility Criteria:
Inclusion Criteria:
1. Community-dwelling men and women aged 60 or above.
2. Current cognitive complaints per participant self-report, but with intact cognitive function as defined by a score of 0-9 on the Short Blessed Test (SBT) and a Montreal Cognitive Assessment (MoCA) score ≥25 per PI discretion.
3. PROMIS depression scale score of greater or equal to 16 and/or PROMIS anxiety score greater or equal to 14.
4. Ability to read and speak English fluently enough to complete all research assessments.
5. Corrected visual ability to read newspaper headlines.
6. Hearing capacity to respond to a raised conversational voice.
7. Willingness and ability to provide informed consent.
Exclusion Criteria:
1. The Mini-International Neuropsychiatric Interview (MINI) criteria for current or life-time bipolar disorder, schizophrenia, schizoaffective disorder.
2. Untreated current post-traumatic stress disorder.
3. A MoCA score \<25 or SBT score \>9, per PI discretion.
4. Use of cognitive enhancers (namely, cholinesterase inhibitors such as donepezil; or memantine) within the past 6 weeks.
5. MINI criteria for any substance abuse within 6 months that would affect their participation, per PI discretion.
6. Unstable medical illness (e.g. uncontrolled diabetes mellitus or hypertension).
7. Concurrent cognitive training, such as brain-training software, participation in psychotherapy or regular engagement in mindfulness practice and/or yoga.
8. Taking anticonvulsant or antipsychotics that cannot be safely tapered and discontinued.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03653351
Study Brief:
Protocol Section:
NCT03653351