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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT07273604
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of relapsing-remitting multiple sclerosis according to standard clinical criteria.
* Expanded Disability Status Scale (EDSS) score between 0 and 3.5.
* Mild to moderate cognitive impairment defined as: up to two BRB-N subtests with scores \< -2 SD.
* Presence of anxiety or depressive symptoms defined as:
* HADS: score \> 8 on one or both subscales, and/or
* BDI-II: score \> 8.
* Stable disease-modifying treatment for ≥ 3 months.
* Ability to provide written informed consent.
Exclusion Criteria:
* Progressive forms of multiple sclerosis (SPMS or PPMS).
* Severe cognitive impairment preventing participation in psychological sessions.
* Active psychiatric or neurological disorders unrelated to MS.
* Participation in another psychological or pharmacological intervention study.
* Recent initiation or modification of disease-modifying treatment (\< 3 months).
* Substance abuse or dependence within the past year.
* Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07273604
Study Brief:
Protocol Section:
NCT07273604