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COMPLETED
NCT07273604
NA

Psychological Interventions for Multiple Sclerosis: Effects on Anxiety, Depression, and Cognition.

Sponsor: Moisés Bermúdez Hernández

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2015-02-01

Completion Date

2019-01-01

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

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.

BEHAVIORAL

Psychophysiological Regulation Therapy (PRT)

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.

Locations (1)

Faculty of Psychology, University of La Laguna Department of Clinical Psychology, Psychobiology and Methodology of Behavioral Sciences Campus de Guajara, Calle Heraclio Sánchez, s/n 38200 San Cristóbal de La Laguna, Santa Cruz de Tenerife Spain

San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain