CompletedNot Applicable

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

Spain140 participantsStarted 2015-02-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of relapsing-remitting multiple sclerosis according to standard clinical criteria. * Expanded Disability Status Scale (EDSS) score between 0 and 3.5. * Mild to moderate cognitive impairment defined as: up to two BRB-N subtests with scores \< -2 SD. * Presence of anxiety or depressive symptoms defined as: * HADS: score \> 8 on one or both subscales, and/or * BDI-II: score \> 8. * Stable disease-modifying treatment for ≥ 3 months. * Ability to provide written informed consent. Exclusion Criteria: * Progressive forms of multiple sclerosis (SPMS or PPMS). * Severe cognitive impairment preventing participation in psychological sessions. * Active psychiatric or neurological disorders unrelated to MS. * Participation in another psychological or pharmacological intervention study. * Recent initiation or modification of disease-modifying treatment (\< 3 months). * Substance abuse or dependence within the past year. * Inability to provide informed consent.

What they're measuring

Fatigue Severity Scale (FSS) - Total Score

Timeframe: Baseline and 12 weeks.

Multiple Sclerosis Quality of Life-54 (MSQoL-54) - Total and Subscale Scores

Timeframe: Baseline and 12 weeks.

Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) - Total Score

Timeframe: Baseline and 12 weeks.

Verbal Selective Reminding Test (SRT) - Total Recall Score

Timeframe: Baseline and 12 weeks.

10/36 Spatial Recall Test (SPART) - Total Recall Score

Timeframe: Baseline and 12 weeks.

Paced Auditory Serial Addition Test (PASAT) - 3-Second Version

Timeframe: Baseline and 12 weeks.

Symbol Digit Modalities Test (SDMT) - Oral Version

Timeframe: Baseline and 12 weeks.

Controlled Oral Word Association Test (COWAT) - Semantic Fluency ("Animals" Category)

Timeframe: Baseline and 12 weeks.

Trial details

NCT IDNCT07273604

SponsorMoisés Bermúdez Hernández

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-01

View on ClinicalTrials.gov More Multiple Sclerosis (MS) - Relapsing-remitting trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fatigue Severity Scale (FSS) - Total Score

Timeframe: Baseline and 12 weeks.

Multiple Sclerosis Quality of Life-54 (MSQoL-54) - Total and Subscale Scores

Timeframe: Baseline and 12 weeks.

Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) - Total Score

Timeframe: Baseline and 12 weeks.

Verbal Selective Reminding Test (SRT) - Total Recall Score

Timeframe: Baseline and 12 weeks.

10/36 Spatial Recall Test (SPART) - Total Recall Score

Timeframe: Baseline and 12 weeks.

Paced Auditory Serial Addition Test (PASAT) - 3-Second Version

Timeframe: Baseline and 12 weeks.

Symbol Digit Modalities Test (SDMT) - Oral Version

Timeframe: Baseline and 12 weeks.

Controlled Oral Word Association Test (COWAT) - Semantic Fluency ("Animals" Category)

Timeframe: Baseline and 12 weeks.