Study Protocol of Online DBT-Mindfulness Intervention in Multiple Sclerosis

NCT05938842 | Unknown

• 1 other identifier: ODMiMS229/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; online intervention; Dialectal behaviour therapy; Mindfulness

Outcome Measures

Primary Outcomes (2)

• Changes in emotion dysregulation

  Changes in emotion dysregulation will be assessed by the 16-ítem Difficulties in Emotion Regulation Scale (DERS). Higher scores in this scale indicate greater emotion dysregulation (score range 16 to 80). The DERS has good internal consistency and test-retest reliability, and adequate convergent and discriminant validity in large community samples.

  baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up

• Changes in decentering

  Decentering will be measured using The Experiences Questionnaire (EQ), validated in the Spanish population. This instrument is a self - reported questionnaire that examine decentering and rumination. It showed a good reliability and it seems adequate to detect changes after mindfulness-based interventions.

  baseline (pre-group assignment), at the end of the intervention (up to 10 weeks) and at three-months follow-up

Secondary Outcomes (4)

• Changes in fatigue

  Baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up

• Changes in depression and anxiety

  Baseline (pre-group assignment), at the end of the intervention (up to 10 weeks), and at three-months follow-up

• Changes 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

Other Outcomes (1)

• Feasibility of the study

  At the end of the intervention (up to 10 weeks)

Study Arms (2)

Online DBT-Mindfulness intervention

EXPERIMENTAL

Experimental group Dialectical behavior therapy (DBT) is a type of cognitive behavioral intervention. The module of Mindfulness is directed to balance emotion with reasoning in order to achieve "wise mind", to act with awareness and to decrease characteristic mood dependent.

Behavioral: Online DBT-Mindfulness Intervention

Online psychoeducational intervention

ACTIVE COMPARATOR

Active control group,

Behavioral: Online psychoeducational intervention

Interventions

Online DBT-Mindfulness Intervention BEHAVIORAL

The whole intervention exists of 10 sessions, one session a week for at least one hour and a half. The session 1 is tailored to address specific issues to people with MS, whereas the sessions 2 to 7 are based on DBT and mindfulness contents, and in sessions 7 to 10 introduced some contents of ACT. The program is based in teaching two different sets "what" and "how" (Linehan, 1993). The first skill "what", teaches patients to simply observe; in a second level, to describe, which implies the ability to put the name to what one has observed; and in the third, "what" skill patients learn to fully participate in their actions in the current moment and without self-consciousness (Soler et al., 2012). In the other hand, the skills of "how" are related to how observe, how to describe and how to participate. Moreover, some mindfulness skills such as "Observing the breath", "Half-smiling", "Awareness" are practice introduced as homework tasks.

Online DBT-Mindfulness intervention

Online psychoeducational intervention BEHAVIORAL

The active control group intervention will be based on a psycho-educational framework and will involve MS-related topics (Oz \& Oz, 2020). The psychoeducational intervention will be conducted by a psychologist with experience in working with pwMS through group videoconference and will follow similar format as the DBT-Mindfulness intervention, except for the homework tasks. The participants will receive information about different aspects related to the disease (e.g., disease progression, disease-symptoms, stress management, nutrition, sleep hygiene, physical activity, social relationships). The content of the sessions of the psychoeducation program was created based on the current literature about MS. Similar psychoeducational programs were used in other studies before (Oz \& Oz, 2020; Dowd et al., 2015).

Online psychoeducational intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (1)

UVic-UCC

Vic, Barcelona, 08500, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 22225697 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.

  PMID: 25311294 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.

  PMID: 23494767 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.

  PMID: 33221788 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• BRENDA MONTAÑÉS MASIAS

  UVic-UCC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judit Bort Roig, PhD

CONTACT

+34938816164; judit.bort@uvic.cat

Brenda Montañés Masias

CONTACT

+34617118387; brenda.montanes@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Welfare, Health and Quality of Life

Model Details: DBT is a modified version of cognitive-behavioural therapy that places additional emphasis on emotion regulation, distress tolerance, self-acceptance, and validation of experience, and consists in several types of interventions, including the skills training group. One of the module os DBT is Mindfulness, which practice the ability to observe thoughts and feeling as temporary, as opposed to reflections of the reality that are necessarily tru.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 11, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)