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CompletadoNCT07928765Registro de ClinicalTrials.gov

Psychodrama for Adults With Relapsing-Remitting Multiple Sclerosis: A Mixed-Methods Study

Multiple Sclerosis, Relapsing-Remitting

LO ESENCIAL

De qué trata este estudio

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Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 65 años
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
12 Real

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

This single-group, mixed-methods study explored changes following a 13-week group psychodrama programme in adults with relapsing-remitting multiple sclerosis (MS). Participants were recruited from the demyelinating diseases unit of Mersin University Hospital, Türkiye, and attended weekly sessions of approximately 180 minutes in addition to their standard medical treatment. Loneliness, fatigue, cognitive performance, depressive and anxiety symptoms, and sleep quality were assessed at baseline, after the intervention and at 6-month follow-up. Individual semi-structured interviews conducted after the intervention and at follow-up explored participants' experiences of physical, cognitive, psychological and social change. Quantitative and qualitative findings were integrated within a convergent mixed-methods design.

Leer la descripción completa

Background: People with MS frequently experience fatigue, cognitive difficulties, depressive and anxiety symptoms, sleep problems and loneliness. Psychodrama is an action-based group psychotherapy method that may support emotional expression, role flexibility and interpersonal connection, but evidence in MS is limited.

Design: Exploratory convergent mixed-methods study combining a one-group pretest-posttest-follow-up quantitative component with a descriptive phenomenological qualitative component. Both components were given equal priority, analysed separately and then integrated using a joint display.

Intervention: A closed psychodrama group met once weekly for 13 sessions (12 December 2024 to 6 March 2025). Each session lasted approximately 180 minutes and followed the classical structure of warm-up, action and sharing, using techniques such as doubling, role reversal, mirroring, soliloquy, chorus and sociometry. Sessions were facilitated by a psychiatric nurse (PhD) with psychodrama assistant certification and a clinical psychologist with psychodrama training. Two trainer psychodramatists provided supervision before and after each session. Neurology clinicians supported medical follow-up, and a referral pathway to neurology and psychiatric services was in place.

Assessments: Loneliness (UCLA Loneliness Scale short form, ULS-6), fatigue (Modified Fatigue Impact Scale, MFIS), cognitive performance (Symbol Digit Modalities Test, SDMT; California Verbal Learning Test-II, CVLT-II), depressive symptoms (Hamilton Depression Rating Scale, HAM-D), anxiety symptoms (Hamilton Anxiety Rating Scale, HAM-A) and sleep quality (Pittsburgh Sleep Quality Index, PSQI) were assessed at baseline, post-intervention and 6-month follow-up. Individual online semi-structured interviews were conducted at post-intervention and follow-up.

Analysis: Quantitative data were analysed with the Friedman test and pairwise Wilcoxon signed-rank tests in IBM SPSS Statistics. Qualitative data were analysed with Colaizzi's descriptive phenomenological method in MAXQDA by two independent coders. This study was registered retrospectively.

¿Quién podría participar?

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Inclusion Criteria:

  • Diagnosis of relapsing-remitting multiple sclerosis, in remission
  • Age 18 to 65 years
  • Willingness to attend group sessions regularly
  • Written informed consent

Exclusion Criteria:

  • Wheelchair dependence
  • Acute psychiatric disorder
  • Hearing or speech impairment that would prevent group participation
Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
No aplica
Enmascaramiento
Sin enmascaramiento
Psychodrama group

Adults with relapsing-remitting MS attended 13 weekly group psychodrama sessions (approximately 180 minutes each) in addition to standard medical treatment.

Behavioral: Group psychodrama

Group psychodrama BEHAVIORAL

Closed-group psychodrama delivered once weekly for 13 sessions of approximately 180 minutes. Each session followed the warm-up, action and sharing structure and included group-centred exercises, protagonist work and vignettes using doubling, role reversal, mirroring, soliloquy, chorus and sociometry. The programme was shaped flexibly according to needs emerging in the group process rather than a symptom-focused protocol.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change in loneliness

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

Six-item UCLA Loneliness Scale short form (ULS-6); higher scores indicate greater loneliness.

Medidas secundarias

Change in fatigue

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

21-item Modified Fatigue Impact Scale (MFIS), total and physical, cognitive and psychosocial subscale scores; higher scores indicate greater fatigue impact.

Change in information processing speed

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

Symbol Digit Modalities Test (SDMT); higher scores indicate better performance.

Change in verbal learning and memory

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

California Verbal Learning Test-Second Edition (CVLT-II); higher scores indicate better performance.

Change in depressive symptoms

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

17-item clinician-rated Hamilton Depression Rating Scale (HAM-D); higher scores indicate more severe depressive symptoms.

Change in anxiety symptoms

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

14-item clinician-rated Hamilton Anxiety Rating Scale (HAM-A); higher scores indicate more severe anxiety.

Change in sleep quality

Plazo: Baseline, post-intervention (week 13) and 6-month follow-up

Pittsburgh Sleep Quality Index (PSQI) global score; higher scores indicate poorer sleep quality.

Participants' experiences of change

Plazo: Post-intervention (week 13) and 6-month follow-up

Individual semi-structured interviews exploring physical, cognitive, psychological and social changes, analysed with Colaizzi's descriptive phenomenological method.

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Centros de investigación (1)

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1 centros

Mersin University Faculty of Medicine, Department of Neurology, Demyelinating Diseases UnitMersin, Mersin, Turkey (Türkiye)Estado desconocido

Equipo y fechas

Patrocinador principal
Bahçeşehir University
Inicio del estudio
12 dic 2024 Real
Finalización primaria
12 sept 2025 Real
Finalización del estudio
12 sept 2025 Real
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Exploring Therapeutic Change Following Psychodrama in Multiple Sclerosis: A Mixed-Methods Study With 6-Month Follow-Up

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026