Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
Study NCT ID:
NCT07273604
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-11-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychological Interventions for Multiple Sclerosis: Effects on Anxiety, Depression, and Cognition.
Sponsor:
Moisés Bermúdez Hernández
Organization:
Study Overview
Official Title:
Psychological Intervention in Multiple Sclerosis: Efficacy in the Treatment of Anxiety-depressive Symptoms and Cognitive Impairment.
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MS-PSY
Brief 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.
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.
Detailed Description:
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).
. 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PI-60/14 | OTHER | Universidad de La Laguna (ULL) and Hospital Universitario Nuestra Señora de Candelaria (HUNSC) | View |