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Life sciences · Interventional Study
ClinicalTrials.gov · September 30, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07273604). This is a study registration, not published results. Lead sponsor: Moisés Bermúdez Hernández. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 148 participants (ACTUAL). Conditions: Multiple Sclerosis (MS) - Relapsing-remitting, Anxiety, Depression, Cognitive Impairment, Emotional Well-being, Cognitive Behavior Therapy. Interventions: BEHAVIORAL: Cognitive Behavioral Therapy (CBT); BEHAVIORAL: Psychophysiological Regulation Therapy (PRT). Primary outcome measures: Fatigue Severity Scale (FSS) - Total Score , Baseline and 12 weeks.; Multiple Sclerosis Quality of Life-54 (MSQoL-54) - Total and Subscale Scores , Baseline and 12 weeks.; Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) - Total Score , Baseline and 12 weeks.; Verbal Selective Reminding Test (SRT) - Total Recall Score , Baseline and 12 weeks.; 10/36 Spatial Recall Test (SPART) - Total Recall Score , Baseline and 12 weeks.; Paced Auditory Serial Addition Test (PASAT) - 3-Second Version , Baseline and 12 weeks.; Symbol Digit Modalities Test (SDMT) - Oral Version , Baseline and 12 weeks.; Controlled Oral Word Association Test (COWAT) - Semantic Fluency ("Animals" Category) , Baseline and 12 weeks.; Controlled Oral Word Association Test (COWAT) - Phonemic Fluency (F-A-S Letters) , Baseline and 12 weeks.; Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) , Baseline and 12 weeks.; Beck Depression Inventory-II (BDI-II) - Total Score , Baseline and 12 weeks.; Inventario de Situaciones y Respuestas de Ansiedad (ISRA) - Total Score , Baseline and 12 weeks.. Brief summary: This study evaluated the efficacy of two structured psychological interventions in individuals with relapsing-remitting multiple sclerosis (RRMS). The main objective was to evaluate whether Group-Based Cognitive-Behavioral Therapy (CBT) and Psychophysiological Regulation Therapy (PRT) improved emotional well-being and objective cognitive functioning compared with Standard Care (SC). A total of 153 individuals with RRMS were assessed for eligibility, of whom 148 were randomized to one of three study conditions: Group-Based CBT, PRT, or SC (waiting-list control). Participants were allocated using a simple computer-generated randomization sequence with a 1:1:1 allocation ratio. Both active interventions were delivered in small groups over 12 weekly sessions. CBT and PRT shared a common therapeutic framework comprising psychoeducation, mindfulness, psychophysiological regulation strategies, and homework assignments. The CBT condition additionally incorporated specific cognitive-behavioral components during sessions 4-10. Assessments were conducted at baseline and immediately after completion of the 12-week intervention period using standardized psychological and neuropsychological measures. The study evaluated treatment effects across complementary domains of emotional functioning and objective cognitive performance.