Study Protocol of Online DBT-Mindfulness Intervention in Multiple Scle
Online DBT-Mindfulness Intervention for Symptoms in Multiple Sclerosis: Study Protocol of a Randomized Controlled Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Online DBT-Mindfulness Intervention
Compared with
- Online psychoeducational intervention
What it measured
Main measures
Changes in emotion dysregulation
baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up
Changes in decentering
baseline (pre-group assignment), at the end of the intervention (up to 10 weeks) and at three-months follow-up
Other measures (4)
Changes in fatigue
Baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up
FatigueChanges in depression and anxiety
Baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up
Mood and sleepChanges in stress
Baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up (up to
Changes in QoL
Baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 65 · EDSS 0 to 6
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The goal of this clinical trial is to test an Online DBT-Mindfulness intervention in people with Multiple Sclerosis. The results of the online DBT-Mindfulness intervention will be compared to an active control group (psychoeducational intervention) to see if they improve her emotion dysregulation and decentering, and consequently, this benefits also improve symptoms like anxiety, depression, distress, fatigue and quality of life in people with MS.
Papers
Background
Soler J, Valdeperez A, Feliu-Soler A, Pascual JC, Portella MJ, Martin-Blanco A, Alvarez E, Perez V. Effects of the dialectical behavioral therapy-mindfulness module on attention in patients with borderline personality disorder. Behav Res Ther. 2012 Feb;50(2):150-7. doi: 10.1016/j.brat.2011.12.002. Epub 2011 Dec 14.Background
Soler J, Franquesa A, Feliu-Soler A, Cebolla A, Garcia-Campayo J, Tejedor R, Demarzo M, Banos R, Pascual JC, Portella MJ. Assessing decentering: validation, psychometric properties, and clinical usefulness of the Experiences Questionnaire in a Spanish sample. Behav Ther. 2014 Nov;45(6):863-71. doi: 10.1016/j.beth.2014.05.004. Epub 2014 Jun 2.Background
Feliu-Soler A, Pascual JC, Borras X, Portella MJ, Martin-Blanco A, Armario A, Alvarez E, Perez V, Soler J. Effects of dialectical behaviour therapy-mindfulness training on emotional reactivity in borderline personality disorder: preliminary results. Clin Psychol Psychother. 2014 Jul-Aug;21(4):363-70. doi: 10.1002/cpp.1837. Epub 2013 Mar 14.Background
Oz HS, Oz F. A psychoeducation program for stress management and psychosocial problems in multiple sclerosis. Niger J Clin Pract. 2020 Nov;23(11):1598-1606. doi: 10.4103/njcp.njcp_462_19.
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History
Started
Oct 2023
Main results due
Dec 2023
Finished
Jul 2024