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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2019-01-01

Brief Summary

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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.

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Detailed Description

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A randomized controlled trial design will be conducted with allocation to the following groups: treatment group (cognitive-behavioral intervention group, psychophysiological reduction - low performance - and neuropsychological rehabilitation) or control group (waiting list). Assessments will be carried out before and immediately after treatment, and at a six-month follow-up after therapy completion. Additionally, a follow-up magnetic resonance imaging (MRI) will be performed after the intervention, within a period of 1 to 3 months, and again at 6 months post-treatment. This neuroimaging activity is included as part of the clinical practice of the Multiple Sclerosis Unit. Participants: A total of 140 patients with clinically defined relapsing-remitting Multiple Sclerosis (MS) will be studied. Inclusion criteria will include minimal to mild disability according to the Expanded Disability Status Scale (EDSS) (EDSS: 0-3.5), mild to moderate cognitive impairment (BRB-N: up to two subtests with scores \<2 SD), and presence of anxiety and/or depressive symptoms (HADS: scores \>8 on one or both subscales; BDI-II: scores \>8). Participants will be recruited from the Multiple Sclerosis Unit of the University Hospital Nuestra Señora de Candelaria (HUNSC) in Santa Cruz de Tenerife. The sample size calculation was based on the assumption that, to achieve a 90% power for detecting effects on primary measures (BDI-II, HADS, ISRA, BRB-N, etc.). The sample size was calculated based on an ANOVA design (medium effect size, d = 0.5; α = 0.05; power = 80%), estimating a required total of 156 participants (52 per group).

. This estimate may be adjusted throughout data collection due to variability in measures specific to this population. Experience with the initial participant groups and their resulting data will allow refinement of these estimates. Evidence highlights that people with MS exhibit unusually low levels of help-seeking behavior for anxiety and depressive symptoms, emphasizing the need for systematic screening. The Multiple Sclerosis Unit currently follows 587 diagnosed patients. This study also aims, based on initial findings, to broaden inclusion criteria according to preliminary results and to establish comparisons among different forms of MS, thereby improving the external validity of the study. This approach is grounded in the reflections of several authors who note that overly restrictive inclusion criteria (e.g., symptoms, comorbidities) may limit the generalizability of clinical trial results to routine clinical practice. They propose ensuring adequate representation of problems, settings, and therapies, along with systematic treatment monitoring and flexibility in interventions-while maintaining detailed information on their active components. Procedure and Timeline Pre-treatment Evaluation Neurological Evaluation: Initial selection of patients will be conducted at the Multiple Sclerosis Unit of the Neurology Service at the University Hospital Nuestra Señora de Candelaria. A standardized neurological protocol will be requested, including the most relevant clinical history data and neurological examination results. Clinical inclusion criteria: clinically defined relapsingremitting MS and minimal to mild disability level. Psychological Evaluation: Among patients meeting clinical inclusion criteria, an interview will be conducted to identify those reporting cognitive and emotional complaints (including an interview with relatives). Motivation and willingness to collaborate will also be assessed. Upon obtaining informed consent, the evaluation protocol will be administered to determine fulfillment of cognitive and emotional inclusion criteria. Patients meeting the criteria will be randomly assigned to either the intervention group or the control group (waiting list without intervention), considering their anxiety and depression scores as well as cognitive impairment levels. The inclusion period will last approximately four months. Treatment Phase Patients in the treatment group will complete the psychological intervention program over 12 weeks (one weekly session lasting 1 hour and 30 minutes), plus two follow-up sessions. The intervention will follow a cognitive-behavioral framework and consist of a specific program tailored to the characteristics of the identified deficits. It will include didactic sessions, group discussions, and practical exercises. Post-treatment Evaluation This will take place during the week following the end of treatment and will include: Neurological Evaluation: assessment of disability level (EDSS).

Psychological Evaluation: assessment of cognitive, emotional, and quality-of-life variables. Follow-up Evaluation A follow-up assessment will be carried out six months after treatment completion, applying the same evaluation protocol as in previous phases.

The control group will be evaluated at the same time points as the intervention group.

All phases of the study will be conducted at the Multiple Sclerosis Unit of the University Hospital Nuestra Señora de Candelaria (HUNSC).

Conditions

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Multiple Sclerosis (MS) - Relapsing-remitting Anxiety Depression Cognitive Impairment Emotional Well-being Cognitive Behavior Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study employed a three-arm randomized controlled design with participants allocated to Cognitive Behavioral Therapy (CBT), Psychophysiological Regulation Therapy (PRT), or Standard Care (waiting list). Interventions were group-based over 12 weekly sessions, with assessments at baseline and post-intervention. Both CBT and PRT followed structured programs aimed at improving stress coping and reducing anxiety-depressive symptoms through psychoeducation, mindfulness, and psychophysiological regulation. Sessions combined didactic content, group exercises, and homework. CBT emphasized behavioral activation, cognitive restructuring, self-instruction, and social skills training, whereas PRT focused on psychophysiological self-regulation, relaxation, breathing control, and biofeedback exercises.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors were blinded to participants' group allocation. Participants and therapists were aware of the assigned intervention, but evaluators conducting clinical and neuropsychological assessments did not have access to treatment information to minimize bias in data collection.

Study Groups

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Cognitive Behavioral Therapy (CBT)

Participants receive a structured 12-week cognitive-behavioral group intervention designed to improve stress coping and reduce anxiety-depressive symptoms. The program includes psychoeducation, mindfulness, behavioral activation, cognitive restructuring, self-instruction training, and social skills development.

Intervention: Behavioral: Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type 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)

Participants receive a structured 12-week group intervention emphasizing psychophysiological self-regulation. The program includes psychoeducation, mindfulness, relaxation, breathing control, and biofeedback-based exercises aimed at reducing emotional distress and enhancing self-regulation.

Group Type EXPERIMENTAL

Psychophysiological Regulation Therapy (PRT)

Intervention Type 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.

Standard Care (SC)

Participants in the control group remain on a waiting list and receive standard medical care provided by the Multiple Sclerosis Unit during the study period. After study completion, they are offered participation in one of the active interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No