Online DBT-Mindfulness intervention for people with Multiple Sclerosis
Online DBT-Mindfulness Intervention for Symptoms in Multiple Sclerosis: Study Protocol of a Randomized Controlled Trial
NA · University of Vic - Central University of Catalonia · NCT05938842
This study is testing whether an online program that combines Dialectical Behavior Therapy and mindfulness can help people with Multiple Sclerosis manage their emotions better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Vic - Central University of Catalonia (other) |
| Locations | 1 site (Vic, Barcelona) |
| Trial ID | NCT05938842 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an online Dialectical Behavior Therapy (DBT) and mindfulness intervention for individuals diagnosed with Multiple Sclerosis (MS). Participants will be randomly assigned to either the DBT-Mindfulness intervention group or an active control group receiving psychoeducational support. The study will utilize a mixed-methods approach, combining quantitative assessments of emotional dysregulation and qualitative feedback on the intervention's usability and acceptability. A total of 48 patients will be recruited from the neurology outpatient department at the University Hospital of Vic.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Multiple Sclerosis who have internet access and can understand Catalan or Spanish.
Not a fit: Patients with substantial cognitive deficits, concurrent psychotherapy, or a history of severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve emotional regulation, reduce anxiety and depression, and enhance the overall quality of life for patients with Multiple Sclerosis.
How similar studies have performed: While the specific combination of DBT and mindfulness for MS is novel, similar interventions have shown promise in improving mental health outcomes in other chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed MS by a neurologist * to have internet access * to have a Expanded Disability Status Scale (EDSS) score between 0-6'5 * to have adequate Catalan or Spanish language comprehension. Exclusion Criteria: * have a substantial cognitive dèficit * be in concurrent individual or group psychotherapy * have a history of schizophrenia or other psychotic symptoms * have history of alcohol or substance abuse or dependence within 6 months of study entry * have a substantial psychiatric disorder or met DSM 5 criteria for Major Depression or suicide ideation * have meditation experience or are currently practicing meditation or yoga.
Where this trial is running
Vic, Barcelona
- UVic-UCC — Vic, Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: BRENDA MONTAÑÉS MASIAS — UVic-UCC
- Study coordinator: Judit Bort Roig, PhD
- Email: judit.bort@uvic.cat
- Phone: +34938816164
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, Multiple sclerosis, online intervention, Dialectal behaviour therapy, Mindfulness