|- candidate number||27338|
|- NTR Number||NTR6459|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mei-2017|
|- Secondary IDs||METC 2017.009 CWO-nr. 16-14|
|- Public Title||Cognitive rehabilitation and mindfulness in multiple sclerosis|
|- Scientific Title||The effect of cognitive rehabilitation therapy and mindfulness-based cognitive therapy on cognitive function in multiple sclerosis|
|- hypothesis||We hypothesize that both cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT) positively affect the primary outcome measure subjective cognitive function compared to enhanced treatment as usual (ETAU). Secondarily, we expect positive effects on the secondary outcome measures objective cognitive functioning, functional brain network measures, psychological symptoms, well-being, quality of life and daily life functioning. Additionally, we will exploratory evaluate whether there are differences in intervention effects between CRT and MBCT. |
|- Healt Condition(s) or Problem(s) studied||Multiple sclerosis (MS), Cognitive functions|
|- Inclusion criteria||Participants are eligible to participate if they meet the following criteria: |
(1) between 18 and 65 years of age,
(2) confirmed MS according to the McDonald 2010 criteria,
(3) a minimum score of 23 on the Multiple Sclerosis Neuropsychological Questionnaire – Patient version (MSNQ-P), which measures subjective cognitive complaints.
|- Exclusion criteria||Participants who meet any of the following criteria are excluded from participation: |
(2) suicidal ideation,
(3) an inability to speak or read Dutch,
(4) previous experience with a similar intervention,
(5) physical or cognitive disabilities, comorbidities or treatments that would interfere too much with the interventions to enrol in this study (to be evaluated on an individual level).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||11-jul-2017|
|- planned closingdate||1-jan-2020|
|- Target number of participants||120|
|- Interventions||Cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT).|
Control condition: enhanced treatment as usual (ETAU).
|- Primary outcome||Subjective cognitive complaints |
|- Secondary outcome||- Objective cognitive function (neuropsychological examination based on the Minimal Assessment of Cognitive Function in MS (MACFIMS)), |
- Functional brain networks (magnetoencephalography (MEG)),
- Psychological symptoms (depression, anxiety, fatigue, rumination),
- Quality of life,
- Well-being (the ability to be mindful, self-compassion, and emotional, psychological and social well-being),
- Daily life functioning.
|- Timepoints||Baseline, post-intervention, 6-months follow-up |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc I.M. Nauta|
|- CONTACT for SCIENTIFIC QUERIES||MSc I.M. Nauta|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Dutch MS Research Foundation|
|- Brief summary||The REMIND-MS study is a dual-centre randomised controlled trail (RCT) that will primarily investigate the effect of cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT) on subjectively experienced cognitive problems among MS patients. The study will also investigate the effect of CRT and MBCT on the secondary outcome measures, and we will investigate which factors predict a beneficial effect of the interventions. |
Furthermore, resting-state magnetoencephalography (MEG) data will be obtained to gain additional knowledge about the aetiology of subjective and objective cognitive problems with respect to functional brain networks, and to explore the role of functional brain network changes in the effect of the interventions.
In addition, it will be evaluated whether alterations in the secondary outcome measures are mediating factors that determine subjective cognitive function.
|- Main changes (audit trail)|
|- RECORD||31-mei-2017 - 3-jul-2017|