Primary Outcomes

Description: Conversion to MS according to criteria described by McDonald (Polman et al 2005)

Measure: Conversion to MS yes/no

Time: 24 months

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Secondary Outcomes

Measure: Number of relapse episodes (number per year)

Time: 24 months

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Measure: number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI

Time: 3 months

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Measure: number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI

Time: 12 months

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Measure: number of new brain lesions found in FLAIR MRI or medullary lesions found in T2 MRI

Time: 24 months

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Description: qualitative variable: 0, 1, or >1

Measure: Number of new T1 lesions taking on Gadolinium highlighting

Time: 3 months

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Description: qualitative variable: 0, 1, or >1

Measure: Number of new T1 lesions taking on Gadolinium highlighting

Time: 12 months

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Description: qualitative variable: 0, 1, or >1

Measure: Number of new T1 lesions taking on Gadolinium highlighting

Time: 24 months

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Measure: Number of hyposignal T1 lesions (black holes)

Time: 3 months

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Measure: Number of hyposignal T1 lesions (black holes)

Time: 12 months

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Measure: Number of hyposignal T1 lesions (black holes)

Time: 24 months

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Measure: Lesional burden in mm^3 for each cerebral MRI

Time: 3 months

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Measure: Lesional burden in mm^3 for each cerebral MRI

Time: 12 months

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Measure: Lesional burden in mm^3 for each cerebral MRI

Time: 24 months

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Description: Exact number (semiautomatic measure)

Measure: Total number of Gadolinium highlighted lesions on T1 images

Time: 3 months

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Description: Exact number (semiautomatic measure)

Measure: Total number of Gadolinium highlighted lesions on T1 images

Time: 12 months

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Description: Exact number (semiautomatic measure)

Measure: Total number of Gadolinium highlighted lesions on T1 images

Time: 24 months

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Description: mm^3

Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence

Time: 3 months

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Description: mm^3

Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence

Time: 12 months

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Description: mm^3

Measure: Normalized cerebral volume (SIENAX) obtained from a T13D sequence

Time: 24 months

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Measure: Change in global cerebral volume (mm^3)

Time: baseline versus 24 months

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Measure: EDSS score, including all subscores

Time: baseline

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Measure: EDSS score, including all subscores

Time: 3 months

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Measure: EDSS score, including all subscores

Time: 12 months

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Measure: EDSS score, including all subscores

Time: 24 months

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Measure: EDSS score, including all subscores

Time: after second MS episode (1st relapse)(maximum 24 months)

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Measure: score for the PASAT 3 seconds section of the MSFC score

Time: baseline

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Measure: score for the PASAT 3 seconds section of the MSFC score

Time: 3 months

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Measure: score for the PASAT 3 seconds section of the MSFC score

Time: 12 months

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Measure: score for the PASAT 3 seconds section of the MSFC score

Time: 24 months

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Measure: score for the PASAT 3 seconds section of the MSFC score

Time: after second MS episode (1st relapse)(maximum 24 months)

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Measure: EQ5D questionnaire

Time: baseline

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Measure: EQ5D questionnaire

Time: 3 months

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Measure: EQ5D questionnaire

Time: 12 months

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Measure: EQ5D questionnaire

Time: 24 months

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Measure: SF36 questionnaire

Time: baseline

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Measure: SF36 questionnaire

Time: 3 months

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Measure: SF36 questionnaire

Time: 12 months

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Measure: SF36 questionnaire

Time: 24 months

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Measure: FSMC fatigue scale

Time: baseline

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Measure: FSMC fatigue scale

Time: 3 months

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Measure: FSMC fatigue scale

Time: 12 months

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Measure: FSMC fatigue scale

Time: 24 months

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Measure: TLS-QOL10 questionnaire

Time: baseline

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Measure: TLS-QOL10 questionnaire

Time: 3 months

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Measure: TLS-QOL10 questionnaire

Time: 12 months

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Measure: TLS-QOL10 questionnaire

Time: 24 months

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Measure: TLS-Coping10 questionnaire

Time: baseline

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Measure: TLS-Coping10 questionnaire

Time: 3 months

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Measure: TLS-Coping10 questionnaire

Time: 12 months

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Measure: TLS-Coping10 questionnaire

Time: 24 months

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Measure: HADS questionnaire

Time: baseline

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Measure: HADS questionnaire

Time: 3 months

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Measure: HADS questionnaire

Time: 12 months

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Measure: HADS questionnaire

Time: 24 months

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Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.

Measure: Presence/absence of adverse events

Time: baseline

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Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.

Measure: Presence/absence of adverse events

Time: 3 months

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Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.

Measure: Presence/absence of adverse events

Time: 6 months

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Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.

Measure: Presence/absence of adverse events

Time: 12 months

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Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.

Measure: Presence/absence of adverse events

Time: 18 months

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Description: Presence/absence of adverse events the severity of which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 3. Grades I, II, III, IV, V.

Measure: Presence/absence of adverse events

Time: 24 months

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: baseline

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: 3 months

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: 6 months

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: 12 months

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: 18 months

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: 24 months

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Measure: 25(OH)D2+D3 serum level (nmol/l)

Time: upon conversion to MS (maximum 24 months)

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Measure: Calciuria/creatinuria

Time: baseline

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Measure: Calciuria/creatinuria

Time: 3 months

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Measure: Calciuria/creatinuria

Time: 6 months

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Measure: Calciuria/creatinuria

Time: 12 months

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Measure: Calciuria/creatinuria

Time: 18 months

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Measure: Calciuria/creatinuria

Time: 24 months

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Measure: Calciuria/creatinuria

Time: upon conversion to MS (maximum 24 months)

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Description: The number of days that pass from the beginning of treatment to conversion to MS according to McDonald 2005 criteria (Polman et al 2005)

Measure: Delay until conversion to MS

Time: 24 months

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Other Outcomes

Measure: DNA sample (blood sample) for biobank

Time: baseline

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Measure: Hemogram

Time: baseline

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Measure: Hemogram

Time: 3 months

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Measure: Hemogram

Time: 6 months

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Measure: Hemogram

Time: 12 months

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Measure: Hemogram

Time: 18 months

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Measure: Hemogram

Time: 24 months

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Measure: Hemogram

Time: upon conversion to MS (maximum 24 months)

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Measure: alanine amino transferase serum levels

Time: baseline

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Measure: alanine amino transferase serum levels

Time: 3 months

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Measure: alanine amino transferase serum levels

Time: 6 months

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Measure: alanine amino transferase serum levels

Time: 12 months

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Measure: alanine amino transferase serum levels

Time: 18 months

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Measure: alanine amino transferase serum levels

Time: 24 months

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Measure: alanine amino transferase serum levels

Time: upon conversion to MS (maximum 24 months)

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Measure: aspartate aminotransferase serum levels

Time: baseline

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Measure: aspartate aminotransferase serum levels

Time: 3 months

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Measure: aspartate aminotransferase serum levels

Time: 6 months

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Measure: aspartate aminotransferase serum levels

Time: 12 months

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Measure: aspartate aminotransferase serum levels

Time: 18 months

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Measure: aspartate aminotransferase serum levels

Time: 24 months

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Measure: aspartate aminotransferase serum levels

Time: upon conversion to MS (maximum 24 months)

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Measure: alkaline phosphatase serum levels

Time: baseline

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Measure: alkaline phosphatase serum levels

Time: 3 months

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Measure: alkaline phosphatase serum levels

Time: 6 months

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Measure: alkaline phosphatase serum levels

Time: 12 months

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Measure: alkaline phosphatase serum levels

Time: 18 months

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Measure: alkaline phosphatase serum levels

Time: 24 months

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Measure: alkaline phosphatase serum levels

Time: upon conversion to MS (maximum 24 months)

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Measure: serum calcium levels

Time: baseline

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Measure: serum calcium levels

Time: 3 months

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Measure: serum calcium levels

Time: 6 months

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Measure: serum calcium levels

Time: 12 months

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Measure: serum calcium levels

Time: 18 months

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Measure: serum calcium levels

Time: 24 months

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Measure: serum calcium levels

Time: upon conversion to MS (maximum 24 months)

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Measure: serum creatinine levels

Time: baseline

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Measure: serum creatinine levels

Time: 3 months

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Measure: serum creatinine levels

Time: 6 months

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Measure: serum creatinine levels

Time: 12 months

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Measure: serum creatinine levels

Time: 18 months

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Measure: serum creatinine levels

Time: 24 months

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Measure: serum creatinine levels

Time: upon conversion to MS (maximum 24 months)

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Measure: serum albumin levels

Time: baseline

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Measure: serum albumin levels

Time: 3 months

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Measure: serum albumin levels

Time: 6 months

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Measure: serum albumin levels

Time: 12 months

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Measure: serum albumin levels

Time: 18 months

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Measure: serum albumin levels

Time: 24 months

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Measure: serum albumin levels

Time: upon conversion to MS (maximum 24 months)

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Measure: serum urea levels

Time: baseline

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Measure: serum urea levels

Time: 3 months

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Measure: serum urea levels

Time: 6 months

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Measure: serum urea levels

Time: 12 months

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Measure: serum urea levels

Time: 18 months

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Measure: serum urea levels

Time: 24 months

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Measure: serum urea levels

Time: upon conversion to MS (maximum 24 months)

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Measure: serum bilirubin levels

Time: baseline

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Measure: serum bilirubin levels

Time: 3 months

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Measure: serum bilirubin levels

Time: 6 months

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Measure: serum bilirubin levels

Time: 12 months

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Measure: serum bilirubin levels

Time: 18 months

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Measure: serum bilirubin levels

Time: 24 months

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Measure: serum bilirubin levels

Time: upon conversion to MS (maximum 24 months)

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Measure: serum electrolyte panel

Time: baseline

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Measure: serum electrolyte panel

Time: 3 months

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Measure: serum electrolyte panel

Time: 6 months

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Measure: serum electrolyte panel

Time: 12 months

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Measure: serum electrolyte panel

Time: 18 months

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Measure: serum electrolyte panel

Time: 24 months

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Measure: serum electrolyte panel

Time: upon conversion to MS (maximum 24 months)

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Primary Outcomes

Description: • Clinical version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) the severity and the checklist.

Measure: Change in Y-BOCS:

Time: Baseline and at 14 weeks and at 6 months post-treatment

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Description: • Obsessive-Compulsive Inventory-Revised (OCI-R) assessing 6 dimensions (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing).

Measure: Change in OCI-R:

Time: Baseline, at 14 weeks and at 6 months post-treatment

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Description: • Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation).

Measure: Change in OBQ-44:

Time: Baseline and at 14 weeks

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Description: • Functional Magnetic Resonance Imaging: Resting state and during task performance (Autobiographical memory + N-Back) and self-reference.

Measure: Changes in functional brain circuits:

Time: Baseline and at 14 weeks

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Secondary Outcomes

Description: • Anxiety Sensitivity Index (ASI-3)

Measure: Change in anxiety:

Time: Baseline and at 14 weeks

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Description: • The Beck Depression Inventory (BDI-II)

Measure: Change in mood from baseline:

Time: Baseline, at 14 weeks and at 6 months post-treatment

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Description: • Positive and Negative Affect trait (PANAS)

Measure: Change in positive and negative affect:

Time: Baseline and at 14 weeks

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Description: • Perceived Stress Scale (PSS)

Measure: Impact of current life events:

Time: Baseline, 14 weeks and at 6 months post-treatment

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Description: • Childhood Trauma Questionnaire (CTQ)

Measure: Impact of past stressful life events:

Time: Baseline

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Description: • Conners' Continuous Performance Test II : CPT-II

Measure: Change in attentional domains:

Time: Baseline and at 14 weeks

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Description: • Wisconsin Card Sorting Test: WCST

Measure: Change in executive Functioning/Cognitive flexibility:

Time: Baseline and at 14 weeks

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Description: • Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).

Measure: Autobiographical memories:

Time: Baseline

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Description: • Phonetic Fluency: PMR (Spanish version of the FAS)

Measure: Change in verbal fluency:

Time: Baseline, 14 weeks and at 6 months post-treatment

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Description: • Word Task: Assessment of language fluency and thought content using a list of 10 seed words from the Spanish adaptation of the ANEW (Affective Norms for English Words) in terms of positive and negative valance and different degrees of arousal.

Measure: Speech analysis:

Time: Baseline

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Description: • ES-Questionnaire, designed by Drs. J. Andrews-Hanna and M. López-Solà (research collaborators of the project) from the USA. It is based on 23 questions that examines the thought content from the patient before, during and after the treatment.

Measure: Thought content:

Time: Baseline, each week during the treatment period (10 sessions) and post-treatment

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Description: • Multicultural Quality of Life Index (MQLI).

Measure: Change in Quality of Life:

Time: Baseline, 14 weeks and at 6 months post-treatment

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Description: • Mindfulness measures include: The Five Facet Mindfulness Questionnaire (FFMQ), used to measure the five constructs central to mindfulness (Observing, Describing, Acting with Awareness, Non-judgment of Inner Experience, and Non-reactivity to Inner Experience).

Measure: Change in Mindfulness variables:

Time: Baseline, 14 weeks and at 6 months post-treatment

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Description: • Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.

Measure: Change in Rumination:

Time: Baseline, 14 weeks and at 6 months post-treatment

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Description: • Credibility Expectancy Questionnaire (CEQ).

Measure: Treatment expectancy:

Time: Baseline

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Description: • Structural acquisition: T13D

Measure: Changes in structural brain regions:

Time: Baseline and at 14 weeks

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