Efficacy of MBI for Depressive Symptoms in Patients With MS
The Efficacy of a Mindfulness Based Intervention for Depressive Symptoms in Patients With Multiple Sclerosis and Their Caregivers. A Randomized Controlled Clinical Trial.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Mindfulness
Compared with
- Psychoeducation
What it measured
Main measures
depression score
6 months follow-up
MRI lesionsMood and sleep
Other measures (2)
mood disorder
6 months follow-up
MRI lesionsMood and sleepQoL
6 months follow-up
MRI lesionsQuality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 65
Show the full criteria
Inclusion criteria
* definite diagnosis of MS (Mc Donald Criteria) evaluated by a neurologist at least six months prior the beginning of the study; * relapsing-remitting and secondary progressive disease; * age 18-65 years old; * clinically inactive phase of the disease ; * a score >13 on the Beck Depression Inventory-II (according to Goldman Consensus Group, 2005); * an Expanded Disability Status Scale (EDSS) score of =6; * fluent Italian speaker; * legal capacity to consent to the treatment; * willingness to abstain from or to suspend all concomitant psychological treatment; * suspension of all psychotropic medications at least one month before the treatment or maintenance at baseline level throughout the study.
Exclusion criteria
* current severe Major Depressive Disorder; * severe suicidality, including ideation, plan, and intent; * current serious psychological and psychiatric disorders, including psychotic disorders, bipolar disorders, active substance abuse (as assessed by the SCID); * presence of overt dementia; * corticosteroid treatment during the previous 30 days; * other serious medical disorders in addition to MS; * pregnancy.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple Sclerosis has a great impact on psychological functioning of patients and can be associated with various psychological disorders and symptoms. The most prevalent one is depression, which ranges from 15% to 47%. Mindfulness Based Intervention (MBI) is a relatively brief and cost-effective program that has been studied in patients with several diseases. Aims. To evaluate the efficacy of a group-based MBI on depressive symptoms, QoL and on correlated symptoms of MS patients and their caregivers. Methods. The study design is a randomized controlled clinical trial. The subjects of the study are 88 patients with MS and depressive symptoms that will be pre-screened from among a catchment group of about 500 patients using the Beck Depression Inventory-II (BDI). The 88 patients will subsequently be randomized into two groups (44 in the experimental group and 44 in the active control group). The psychological assessment, independent and blind to treatment, will be performed with the same timing and tools: at baseline (T0), after treatment (T1), and 6 months after the end of the group intervention (T2). The assessment will encompass the administration of the clinical interview and other self-report questionnaires. The experimental group will undergo a 8 weekly sessions of 3 hours each (plus an all day session) with group based MBI. The MBI is an Mindfulness Based Stress Reduction protocol integrated with body centered techniques from Sensorimotor Psychotherapy, in order to better tailor it on the needs of people with MS suffering from depressive symptoms. The active control group is designed to control for the non-specific elements of the MBI treatment and will follow the same structure as the MBI. It will be based on a psycho-educational framework and will include relaxation techniques. Primary outcome measures in patients will be: 1) the proportion of participants at T1 and T2 that does not have a BDI-II score greater than 13; 2) the proportion of patients no longer meeting the diagnostic criteria for mood disorders as assesses by the SCID; 3) the improvement of FAMS scores for the six primary aspects of QoL.
Papers
Results
Carletto S, Tesio V, Borghi M, Francone D, Scavelli F, Bertino G, Malucchi S, Bertolotto A, Oliva F, Torta R, Ostacoli L. The Effectiveness of a Body-Affective Mindfulness Intervention for Multiple Sclerosis Patients with Depressive Symptoms: A Randomized Controlled Clinical Trial. Front Psychol. 2017 Nov 30;8:2083. doi: 10.3389/fpsyg.2017.02083. eCollection 2017.Results
Carletto S, Borghi M, Francone D, Scavelli F, Bertino G, Cavallo M, Malucchi S, Bertolotto A, Oliva F, Ostacoli L. 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. BMC Neurol. 2016 Jan 13;16:7. doi: 10.1186/s12883-016-0528-0.
Loading reviews and guidelines…
History
Started
May 2014
Main results due
Dec 2016
Finished
May 2017