Evidence map›Paper›PMID 26757728›Full record

ArticleBMC neurology2016

The efficacy of a Mindfulness Based Intervention for depressive symptoms in patients with Multiple Sclerosis and their caregivers: study protocol for a randomized controlled clinical trial.

Sara Carletto, Martina Borghi, Diana Francone, Francesco Scavelli, Gabriella Bertino, Marco Cavallo, Simona Malucchi, Antonio Bertolotto, Francesco Oliva, Luca Ostacoli

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02611401 (The Efficacy of a Mindfulness Based Intervention for Depressive Symptoms in Patients With Multiple Sclerosis and Their Caregivers. A Randomized Controlled Clinical Trial.), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02611401 nacompletednot on this map

The Efficacy of a Mindfulness Based Intervention for Depressive Symptoms in Patients With Multiple Sclerosis and Their Caregivers. A Randomized Controlled Clinical Trial.

TypeinterventionalSponsorUniversity of Turin, ItalyRan2014 to 2017Enrolled88ConditionsMultiple Sclerosis, DepressionArmsMindfulness, Psychoeducation
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Sara CarlettoClinical Psychology and Psychosomatics Service, A.O.U. San Luigi Gonzaga, University of Turin, Regione Gonzole 10, Orbassano, TO, 10043, Italy. sara.carletto@unito.it.
Martina BorghiClinical Psychology and Psychosomatics Service, A.O.U. San Luigi Gonzaga, University of Turin, Regione Gonzole 10, Orbassano, TO, 10043, Italy. martina.borghi@gmail.com.
Diana FranconeClinical Psychology and Psychosomatics Service, A.O.U. San Luigi Gonzaga, University of Turin, Regione Gonzole 10, Orbassano, TO, 10043, Italy. diana.francone@libero.it.
Francesco ScavelliClinical Psychology and Psychosomatics Service, A.O.U. San Luigi Gonzaga, University of Turin, Regione Gonzole 10, Orbassano, TO, 10043, Italy. francesco-sc@hotmail.it.
Gabriella BertinoClinical Psychology and Psychosomatics Service, A.O.U. San Luigi Gonzaga, University of Turin, Regione Gonzole 10, Orbassano, TO, 10043, Italy. bertino.gabri@gmail.com.
Marco CavalloeCampus University, Via Isimbardi, Novedrate, Como, 10-22060, Italy. marcocavallo79@libero.it.
Simona MalucchiNeurologia 2-CRESM (Centro Riferimento Regionale Sclerosi Multipla), AOU San Luigi, Regione Gonzole 10, Orbassano, TO, 10043, Italy. simona.malucchi@gmail.com.
Antonio BertolottoNeurologia 2-CRESM (Centro Riferimento Regionale Sclerosi Multipla), AOU San Luigi, Regione Gonzole 10, Orbassano, TO, 10043, Italy. antonio.bertolotto@gmail.com.
Francesco OlivaClinical and Biological Sciences Department, University of Turin, A.O.U. San Luigi Gonzaga, Regione Gonzole 10, Orbassano, TO, 10043, Italy. francesco.oliva@unito.it.
Luca OstacoliClinical Psychology and Psychosomatics Service, A.O.U. San Luigi Gonzaga, University of Turin, Regione Gonzole 10, Orbassano, TO, 10043, Italy. luca.ostacoli@unito.it.
Ospedale San Luigi Gonzaga · ITUniversità degli Studi eCampus · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMultiple Sclerosis has a great impact on psychological functioning of patients and can be associated with various mental health disorders and symptoms. The most prevalent one is depression, which ranges from 15 to 47%. Mindfulness Based Interventions are a relatively brief and cost-effective program that has been studied in patients with several chronic diseases and recently also in patients with Multiple Sclerosis. Mindfulness Based Interventions are based on the assumption that a non-judgmental awareness and acceptance of one's moment-to-moment experience can have a positive effect on the adaptation to the disease, reducing the psychological burden and improving patients' quality of life. Several studies concluded that Mindfulness Based Interventions can be beneficial in terms of improving both psychological and psychical aspects of Multiple Sclerosis, but none of them compared the intervention with an active control group. The primary objective of the study is to evaluate the efficacy of a group-based Mindfulness Based Intervention on depressive symptoms in patients with Multiple Sclerosis, as compared with an active control group.

methodsThe study design is a randomized controlled clinical trial. Eighty-eight patients with Multiple Sclerosis and depressive symptoms will be recruited and randomized to either Mindfulness Based Intervention or an active control group. The latter is designed to control for non-specific elements of the intervention and it comprises psycho-education and relaxation techniques. The primary outcome is the reduction of depressive symptoms as measured via the Beck Depressive Inventory-II. Secondary outcome measures are level of quality of life, anxiety, perceived stress, illness perception, fatigue and quality of interpersonal relationship. Outcomes will be assessed at baseline, after treatment and 6 months after the end of the treatment. Caregivers will participate in groups together with patients. DISCUSSION: As far as we know this trial will be the first randomized controlled trial testing the efficacy of group-based Mindfulness Based Intervention for patients with Multiple Sclerosis with a comparison with an active control group with a specific focus on depressive symptoms.

trial registrationNCT02611401.

Indexed as

Clinical ProtocolsAdultCaregiversDepressionFemaleHumansMaleMiddle AgedMindfulnessMultiple SclerosisOutcome Assessment, Health CareRandomized Controlled Trials as Topic

Identifiers

PMID26757728
PMCPMC4711056
OpenAlexW2236803891

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.