Efficacy of MBI for Depressive Symptoms in Patients With MS

NCT02611401 | Completed

• 1 other identifier: University of Turin
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

multiple sclerosis; depression; mindfulness

Outcome Measures

Primary Outcomes (1)

• depression score

  the proportion of participants at T2 that do not have a BDI-II score greater than 13

  6 months follow-up

Secondary Outcomes (2)

• mood disorder

  6 months follow-up

• QoL

  6 months follow-up

Study Arms (2)

Mindulness Based Intervention

EXPERIMENTAL

intervention with group-based Mindfulness Based Intervention

Behavioral: Mindfulness

Active Control

ACTIVE COMPARATOR

intervention with group-based Psychoeducation and Relaxation

Behavioral: Psychoeducation

Interventions

Mindfulness BEHAVIORAL

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.

Mindulness Based Intervention

Psychoeducation BEHAVIORAL

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.

Active Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead
• Fondazione Italiana Sclerosi Multipla: collaborator

Study Sites (1)

Clinical and Biological Sciences Department

Orbassano, Turin, 10043, Italy

Location

Related Publications (2)

• 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.

  PMID: 29250012 DERIVED

• 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.

  PMID: 26757728 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Depression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• luca ostacoli, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

IT (1)