Psychological Interventions for Multiple Sclerosis: Effects on Anxiety

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

CompletedNot a drug-phase studyRelapsing MSNCT07273604

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Cognitive Behavioral Therapy (CBT)
  • Psychophysiological Regulation Therapy (PRT)

What it measured

Main measures

  • Fatigue Severity Scale (FSS) - Total Score

    Baseline and 12 weeks.

    Fatigue

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

    Baseline and 12 weeks.

    Quality of life (reported by participants)

  • Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) - Total Score

    Baseline and 12 weeks.

    Thinking and memory

  • Verbal Selective Reminding Test (SRT) - Total Recall Score

    Baseline and 12 weeks.

    Thinking and memory

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

    Baseline and 12 weeks.

    Thinking and memory

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

    Baseline and 12 weeks.

    Thinking and memory

  • Symbol Digit Modalities Test (SDMT) - Oral Version

    Baseline and 12 weeks.

    Thinking and memory

  • 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.

    Mood and sleep

  • Beck Depression Inventory-II (BDI-II) - Total Score

    Baseline and 12 weeks.

    Mood and sleep

  • Inventario de Situaciones y Respuestas de Ansiedad (ISRA) - Total Score

    Baseline and 12 weeks.

    Thinking and memoryMood and sleep

Other measures (8)

  • Recent Life Changes Questionnaire (RLCQ) - Total Score

    Baseline and 12 weeks.

  • Symptom Checklist-90-Revised (SCL-90-R) - Global Severity Index (GSI)

    Baseline and 12 weeks.

  • Cognitive Triad Inventory (CTI) - Total Score

    Baseline and 12 weeks.

    Thinking and memoryMood and sleep

  • Intolerance of Uncertainty Scale (IUS) - Total Score

    Baseline and 12 weeks.

  • Social Support Questionnaire (SSQ-6) - Total Score

    Baseline and 12 weeks.

    Quality of life (reported by participants)

  • Pittsburgh Sleep Quality Index (PSQI) - Total Score

    Baseline and 12 weeks.

    Mood and sleep

  • MRI Lesion Activity and Lesion Load

    Baseline and 12 weeks.

    MRI lesions

  • Duke-UNC Functional Social Support Questionnaire (DUFSS) - Total Score

    Baseline and 12 weeks

Who could take part

Relapsing MS · 18 to 65 · EDSS 0 to 3.5

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Feb 2015

    2. Main results due

      Jan 2019

    3. Finished

      Jan 2019

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