Sociocognitive Intervention and Rehabilitation Program in Multiple Sclerosis
NCT07734675, Not applicable, Not yet recruiting, Sonia Batista
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sociocognitive Intervention and Rehabilitation Program in Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT07734675 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 130 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sonia Batista | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis | ClinicalTrials.gov |
| Interventions | Sociocognitive rehabilitation via COGWEB platform combined with an emotional processing intervention. | ClinicalTrials.gov |
| First posted | 2026-07-29 | ClinicalTrials.gov |
| Last updated | 2026-07-29 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Montreal Cognitive Assessment - MoCA (neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Cognitive screening; Score 0-30 (0- worst outcome; 30- best outcome) | ClinicalTrials.gov |
| Primary | Ekman's Faces Test - EFT (neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Social cognition and metacognition; Score 0-35 (0- worst outcome; 35- best outcome) | ClinicalTrials.gov |
| Primary | Reading the Mind in the Eyes Test - RMET (neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Social cognition and metacognition; Score 0-36 (0- worst outcome; 36- best outcome) | ClinicalTrials.gov |
| Primary | Symbol Digit Modalities Test - SDMT (part of BICAMS-Brief International cognitive Assessment Multiple Sclerosis neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Processing speed measures and metacognition; Score 0-110 adjusted for age and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5). | ClinicalTrials.gov |
| Primary | California Verbal Learning Test - CVLT-II (part of BICAMS-Brief International cognitive Assessment Multiple Sclerosis neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Verbal learning, memory and metacognition; Score 0-80 adjusted for age (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5). | ClinicalTrials.gov |
| Primary | Brief Visuospatial Memory Test - BVMT-R (part of BICAMS-Brief International cognitive Assessment Multiple Sclerosis neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Visual learning, memory and metacognition; Score 0-36 adjusted for age (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5). | ClinicalTrials.gov |
| Primary | Paced Auditory Serial Addition Test - PASAT (part of BRBN-T: Brief repeatable battery of neuropsychological tests) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Processing speed measures and metacognition; Score Score 0-60 adjusted for age, gender and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5) | ClinicalTrials.gov |
| Primary | Selective Reminding Test - SRT (part of BRBN-T: Brief repeatable battery of neuropsychological tests) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Verbal learning, memory and metacognition; Score 0-70 adjusted for age, gender (0-male; 1-female) and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5). | ClinicalTrials.gov |
| Primary | 10/36 Spatial Recall Test - SPART (part of BRBN-T: Brief repeatable battery of neuropsychological tests) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Visual learning, memory and metacognition; Score 0-30 adjusted for age, gender and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5). | ClinicalTrials.gov |
| Primary | Word List Generation Test - WLG (part of BRBN-T: Brief repeatable battery of neuropsychological tests) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Language measures and metacognition; Score 0-67 adjusted for gender and education (score enables an intermediate T-score allowing for classification- Presence of Impairment \< 34.5). | ClinicalTrials.gov |
| Primary | Boston Naming Test - BNT (neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Language measures: Score 0-30, calculated based on the number of items correctly named spontaneously. | ClinicalTrials.gov |
| Primary | d2 Test of Attention (neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Measures processing speed, rule compliance, and quality of performance, allowing for an estimation of individual attention, according to several metrics. There is no specified cut-off. | ClinicalTrials.gov |
| Primary | Irregular Word Reading Test - TeLPI (neuropsychological test) | At baseline. | Premorbid intelligence, ability to read irregularly spelled words ; there is no specified cut-off. | ClinicalTrials.gov |
| Primary | Stroop Test (neuropsychological test) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Measures cognitive flexibility, processing speed, and executive function; Score varies according to speed and accuracy abilities. There is no specified cut-off. | ClinicalTrials.gov |
| Secondary | Modified Fatigue Impact Scale - MFIS (PROM: Patient Reported Outcome Measure) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Fatigue; Score 0-84 (Significant fatigue \>= 38) | ClinicalTrials.gov |
| Secondary | Cognitive Reserve Index Questionnaire - CRIq | At baseline | Cognitive reserve: Score 0-24, the higher the score, the higher the cognitive reserve. There is no specified cut-off. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale - HADS (PROM: Patient Reported Outcome Measure) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Anxiety and depression; Score 0-21, normal (0-7); low risk (8-10); moderate risk (11-14); high risk (15-21). | ClinicalTrials.gov |
| Secondary | World Health Organization Quality of Life short-form - WHOQOL-Bref (PROM: Patient Reported Outcome Measure) | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Quality of life; evaluates four main domains: physical health, psychological health, social relationships and family/finantial environment ; Scoring requires averaging the items within each domain to calculate raw scores, which are then linearly transformed to a 0-100 scale. Higher scores denote a higher perceived quality of life. | ClinicalTrials.gov |
| Secondary | Neurofilament Light chain (NfL): pg/mL | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Quantification of biochemical central markers in serum; Healthy individuals frequently present \< 10 pg/mL (according to age); expected levels for patients in relapse: \> 10 pg/mL. | ClinicalTrials.gov |
| Secondary | Glial Fibrillary Acidic Protein (GFAP): pg/mL | At baseline, follow-up 12 months, 18 months and follow-up 24 months | Quantification of biochemical central markers in serum. Levels are influenced by age, sex, and BMI. Currently lacking literature cut-off values for MS patients. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Cancellation Test | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Selective Reminding Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)