Efficacy of MBI for Depressive Symptoms in Patients With MS

Summary

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.

Conditions

• Multiple Sclerosis
• Depression

Interventions

BEHAVIORAL

Mindfulness

The MBI is based on MBSR protocol but in order to maximize the clinical utility in people with MS suffering from depressive symptoms, we will tailor mindfulness intervention on the needs of this specific population. We will apply a modified MBSR protocol integrated with techniques from Sensorimotor Psychotherapy. The MBI comprises an 8-week group program. Participants will took part in a 3 hour single weekly sessions, and there will be also an additional all-day session of 7 hours. Each session will cover specific exercises and topics within the context of mindfulness practice and training. Participants will be required to carry out daily 45-min homework assignments, which consist on mindfulness exercises and mindfulness applications in everyday life.

BEHAVIORAL

Psychoeducation

The control group is designed to control for the nonspecific elements of the MBI treatment. It will be based on a psycho-educational framework and will include some relaxation techniques. In each session is discussed a MS-related topic. Relaxation and gentle stretching exercises will be proposed at the end of each session. Homework and the material (photocopies, slides, etc.) discussed in group sessions is left to each participant to encourage participants to practice exercises between sessions. This intervention will follow the same structure and weekly format of the MBI intervention. The only difference will be the absence of an all-day session.

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla

  collaborator OTHER

• University of Turin, Italy

  lead OTHER

Principal Investigators

• luca ostacoli, MD · University of Turin, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2016-12-31

Completion

2017-05-31

Countries

• Italy

Study Locations