CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
Cognitive Behavioral Therapy (CBT) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07273604
NCT07273604N/ACompleted

Psychological Intervention in Multiple Sclerosis: Efficacy in the Treatment of Anxiety-depressive Symptoms and Cognitive Impairment.

Moisés Bermúdez Hernández·interventional·Posted Dec 9, 2025·Updated Dec 9, 2025

In Brief

A clinical study evaluating Cognitive Behavioral Therapy (CBT) and Psychophysiological Regulation Therapy (PRT) for Multiple Sclerosis (MS) - Relapsing-remitting and 5 related conditions. Completed, enrolled 140 participants across 1 site.

Detailed Summary

This study evaluated the efficacy of two structured psychological interventions for patients with relapsing-remitting multiple sclerosis (RRMS). The main goal was to determine whether a Cognitive Behavioral Therapy (CBT)-based program and a Psychophysiological Regulation Therapy (PRT) improved emotional well-being and cognitive functioning compared with Standard Care (SC). A total of 140 participants with mild to moderate disability and disease duration between 5.5 and 8.5 years were randomly assigned to one of three groups: CBT, PRT, or SC (waiting list). Each intervention was delivered in small groups over 12 weekly sessions. Assessments were conducted before and after treatment using validated clinical and neuropsychological measures. Results were analyzed to explore the effectiveness of both interventions in reducing anxiety and depressive symptoms and enhancing cognitive performance. The study aimed to provide evidence for the inclusion of psychological therapies as complementary treatments in comprehensive care for multiple sclerosis patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 9, 2025
Enrollment StartFeb 1, 2015
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7 months ago

Interventions

Cognitive Behavioral Therapy (CBT)behavioral

A structured 12-week group-based cognitive-behavioral intervention including psychoeducation, mindfulness training, behavioral activation, cognitive restructuring, self-instruction training, and social skills development. Designed to improve coping, reduce anxiety-depressive symptoms, and enhance cognitive and emotional functioning.

Psychophysiological Regulation Therapy (PRT)behavioral

A structured 12-week group-based intervention emphasizing psychophysiological self-regulation through psychoeducation, mindfulness, relaxation, breathing control, and biofeedback-based exercises to reduce emotional distress and promote physiological balance.