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

NCT07273604

CompletedNA

Sponsor: Moisés Bermúdez Hernández

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting, Anxiety, Depression, Cognitive Impairment, Emotional Well-being

Interventions: Cognitive Behavioral Therapy (CBT), Psychophysiological Regulation Therapy (PRT)

Countries: Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (1)
  • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain