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Study Protocol of Online DBT-Mindfulness Intervention in Multiple Sclerosis

NCT05938842 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-11

No results posted yet for this study

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

Interventions

BEHAVIORAL

Online DBT-Mindfulness Intervention

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.

BEHAVIORAL

Online psychoeducational intervention

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).

Sponsors & Collaborators

  • University of Vic - Central University of Catalonia

    lead OTHER

Principal Investigators

  • BRENDA MONTAÑÉS MASIAS · UVic-UCC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-12-31
Completion
2024-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938842 on ClinicalTrials.gov