Design The study design is a mixed-methods approach, under the concurrent nested design.
Quantitative measures are the predominant method, therefore qualitative procedures will be
hierarchically subsumed under quantitative procedures. The quantitative approach will serve
to assess the effectiveness of a using online DBT-Mindfulness intervention to improve emotion
dysregulation, and decentering in a randomized controlled trial (RCT), compared to an active
control group (online psychoeducational intervention). In addition, qualitative measures will
be used to complement and explain the results, and to know intervention usability and
acceptability through the participant's experiences and perceptions.
Sample size In order to maximize participants' opportunities for interaction, peer support
and practice skills; group size for each group must keep small (15-20 participants).
Therefore, we will employ a convenience sample of 40 patients with MS. Estimating a loss of
20% of patients 48 patients will have to be recruited: 24 in the intervention and 24 in the
control group.
Recruitment process Study recruitment will take place in outpatients of neurology diagnosed
with MS at the Universitary Hospital of Vic (UHV). Firstly, project information will be
disseminated at the neurology department of the UHV to recruit sample for the study. They
will receive information regarding eligibility criteria and the recruitment protocol.
Secondly, the neurologist will select potential participants that meet the inclusion and
exclusion criteria and will create a list of those that willing to participate. Then,
according to the procedures established by Ethics Committee of the UHV, the neurologist will
contact the patients and ask for their consent to be contacted by telephone by the study
researchers. Thirdly, participants who accepted will be invited for a face-to-face meeting.
In this first encounter, participants will be provided with detailed information about the
study (i.e. intervention characteristics, data collection, and risks and benefits of
participating in the study). The participants will sign voluntarily the Informed Consent
after reading and understanding the study information. In addition, it will be reminded that
study participation is voluntary, and they will have the right to withdraw from the study at
any time without disruption to their usual care.
Randomisation and allocation procedures Participants attending to the first face-to-face
meeting will be provided with an identification code. Researchers will use an Excel file to
create a random sequence of numbers allocating patients to the intervention and the active
control group by a simple randomization process.
Blinding Both interventions will have similar look and structure of sessions, but different
content whether the patient belongs to the intervention or active control group. The
researcher, in charge of recording and monitoring data, will be blinded to the participant's
group allocation. Due to the intervention is performed online, participants will be blinded
if they will be receiving the DBT-Mindfulness or the psychoeducational treatment.
Intervention The interventions will be delivered in 1h-1h30 weekly sessions over a 10-week
period via Zoom videoconferences. Adherence will be monitorised through attendance at the
session schedule. Reminder emails previous to each sesssion will be used to improve adherence
to interventions.
Online DBT-Mindfulness intervention DBT-Mindfulness intervention is an adaptation from the
original DBT Skills Training Manual. The intervention was adjusted from the original program
for patients with borderline personality disorder. In this intervention, mindfulness skills
were taught in ten consecutive weeks and formal mindfulness practices were encouraged and
reinforced. Modifications concerned information about MS and its psychosocial consequences
and texts and examples applying to MS patients. The adaptation program was performed in
collaboration with several experts (e.g., DBT experts, neurologist, neuropsychologist,
researchers), through different online interviews.
The aim of the module of mindfulness is to balance emotion with reasoning in order to achieve
"wise mind", to act with awareness and to decrease characteristic mood dependent. 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 pwMS, whereas the sessions 2 to 7 are
based on DBT and mindfulness contents, and in sessions 7 to 10 introduced some contents of
ACT.
All group sessions will be facilitated by a clinical psychologist experienced in DBT
intervention. Quality controls of the intervention will be carried out throughout the
sessions, by means of video recordings that will be supervised by a psychologist certificated
in DBT.
Online psychoeducational intervention The active control group intervention will be based on
a psycho-educational framework and will involve MS-related topics. 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.
Data collection Intervention effectiveness will be measured at baseline (T1: pre-group
assignment), at the end of the intervention (T2: post-intervention, up to 10 week), and at
three-months follow-up (T3: 3months). The baseline assessment will be realized in the first
encounter with the patients in individual and face-to-face format. In this, the patients will
complete the questionnaires with a specialist, that will last a maximum of 1h the assessment.
Then at each time point, study participants will complete the same questionnaires in online
format collected by researchers.
Data management The personal data of the individuals that participate at the project will we
pseudoanonimised by the researcher and identifying information will not be shared with other
participants of the project. Only the code assigned to participants in the study will be
listed in the worklists. In the final report or in case of communicating these results to the
scientific community, their identity will remain anonymous.
The monitorisation of quantitative data will be documented using a Research Electronic Data
Capture (REDCap). REDCap is a secure web-based software System that allows researchers create
online forms for data capture, management, and simple analysis. All the data uploaded to the
REDCap will be anonymous.
Qualitative data will be collected by the research members (BM) at the end of the
intervention (T2). Semi-structured interviews for qualitative data will be delivered
face-to-face by one research members (BM), tape-recorded and transcribed verbatim. Overall
data management will be done by the research members' staff at the University of Vic-Central
University of Catalonia.
Data analysis Quantitative analysis Descriptive analysis will be provided for the primary and
secondary outcomes, reporting the mean and standard deviation (SD). The homogeneity between
groups at baseline will be validated using t-tests for independent samples, except in cases
where the Mann-Whitney U-test is required as non-parametric alternatives, for each variable.
All randomized participants who undergo a baseline assessment will be included in the
analysis, regardless of whether they drop out, withdraw, or are lost to follow-up during the
study, in accordance with the intention-to-treat principle. The Shapiro-Wilk test will be
used to assess the normality of quantitative variables.
The impact of the online DBT-Mindfulness against the psychoeducational intervention will be
tested with mixed linear models with repeated measures. The analyses for primary (emotion
dysregulation, decentering) and secondary outcomes (fatigue, depression, anxiety, stress, and
quality of life) will be measured at the three assessment points,baseline (T1),
postintervention (T2), and follow-up (T3). Covariance analyses will also be conducted,
including age, gender, years of the disease, EDSS and MS type (only it there are more than
one type of MS) and any differences between groups at baseline to provide a better estimate
of the true effect of the intervention by assessing clinical significance.
Estimates of the size of treatment effects will be presented together with confidence
intervals, in addition to significance tests (alpha level of 0.05). SPSS version 25.0
software will be used for statistical analyses.
Qualitative analysis Qualitative analysis will be performed with the Atlas.ti software.
Semi-structurated interviews will be transcribed verbatim. Thematic analysis will be used to
develop themes and categories in the qualitative data base according to: the feelings and
thoughts related to the intervention, the satisfaction with the program and the care received
by the professionals, and impeding and facilitator factors. We will conduct the analysisi of
the transcripts in parallel with ongoing data collection. A researcher of the team (BM) will
keep notes after each interview and throughout the analysis process. Initial codes will use
vocabulary as close as possible to that use the participants themselves to avoid
incorporating preconceptions into the analysis. Patient and professionals quotes to support
the results will be identified and translated from Catalan/Spanish to English. Themes will be
returned to all participants for verifcation. Credibility of the data will be achieved by
reviewing the documents handwritten by the participants and using their complementary
comments, as well as the prolonged commitment of the researcher with the data.
Ethical aspects The trial is developed according to the guidance of Good Clinical Practice
established by the Comitè d'ètica de la UVic-UCC regarding its methodologic, ethical, and
legal aspects. Moreover, if needed, ethics review and approval will be evaluated for all
relevant aspects of the study by the CHV- Fores foundation committee prior the research
initiation. The project will be carried out following the principles of the Declaration of
Helsinki (2013-17), on medical research in people. The trial will be reported and patients
that volunteer will be asked to sign a written informed consent prior to program
participation. The confidentiality of the subjects will be in accordance with regulations of
the Organic law of Protection of Personal Data 3/2018, of December 5, as well as the EU
General Data Protection Regulation (2016/679, GDPR). In accordance with the Organic Law of
1/1982, of May 5, which protects the right to one's own image, empowers its owner to
reproduce their own image and prohibits third parties from obtaining, reproducing and
disclosing the person's image without their consent. Study results will be reported according
to Consolidated Standards of Reporting Trials (CONSORT) recommendations and will also be
reported in the ClinicalTrials.gov registry.
