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Effect of Adapted Physical Activity on Emotion Regulation in People With Depressive Disorders (REAPAD)

21 de agosto de 2026 actualizado por: Centre Hospitalier Georges Mazurelle

Impact d'un Programme d'activité Physique adaptée Sur la régulation Des émotions de Personnes Souffrant de Troubles dépressifs, en Sortie d'Hospitalisation : étude REAPAD

Depression is associated with difficulties in emotion regulation. Adapted physical activity (APA) may help improve emotional regulation in people with depressive disorders.

The REAPAD study evaluates the effects of an adapted physical activity program on emotion regulation in adults with depressive disorders following psychiatric hospitalization. Participants were randomly assigned to one of two APA programs: a standard adapted physical activity program or a combined adapted physical activity program including activities specifically targeting emotional regulation.

Emotion regulation is assessed using the Cognitive Emotion Regulation Questionnaire (CERQ). The study also evaluates depressive symptoms, anxiety, self-esteem, physical activity, physical condition, and other psychological and physical outcomes.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

45

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Vendée
      • La Roche-sur-Yon, Vendée, Francia, 85 000
        • EPSM de Vendée - Centre Hospitalier Georges Mazurelle

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age over 18 years
  • Unipolar or bipolar depressive disorder
  • Discharged from full hospitalization, up to three weeks after discharge
  • Able to provide free and informed consent
  • Not participating in any other research

Exclusion Criteria:

  • High suicidal risk, at the investigator's discretion
  • Medical contraindication to any physical activity
  • Motor, psychological, or intellectual disability, or other medical condition, at the investigator's discretion, preventing full participation in the study
  • Severe addictive disorder impeding participation in the study
  • Psychotic disorder
  • Pregnancy or breastfeeding
  • Any circumstances rendering the participant unable to understand the nature, purpose, or consequences of the trial
  • Under legal protection (guardianship or trusteeship)
  • No social security coverage

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Classical Adapted Physical Activity
Participants received an individualized, moderate-intensity adapted physical activity program consisting of 8 sessions over 6 weeks, with at least one session per week. The program included aerobic training (step-based exercises, lateral stepping and locomotor circuit tasks), lower-limb resistance training (chair stands, step-ups, lateral stepping and lunges), and agility and coordination exercises (agility ladder drills and motor circuit tasks). Session duration progressively increased from 25 minutes for sessions 1 and 8 to 30, 35 and 40 minutes for the intermediate sessions. Each session included a 5-minute warm-up and muscular flexibility period and a 10-minute cool-down period.
Experimental: Combined Adapted Physical Activity Program
Participants received an individualized, moderate-intensity adapted physical activity program consisting of 8 sessions over 6 weeks, with at least one session per week. The program included aerobic training, lower-limb resistance training, and agility and coordination exercises. In addition, cognitive and emotional training tasks were integrated into the physical activity sessions. Cognitive tasks included short-term memory activities, verbal fluency dual tasks and cognitive flexibility exercises. Emotional tasks included identifying, recognizing and expressing emotions using images and photographs of facial expressions. These cognitive and emotional tasks were incorporated during exercises and rest periods throughout the program.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in emotion regulation strategies assessed by the Cognitive Emotion Regulation Questionnaire (CERQ
Periodo de tiempo: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Emotion regulation strategies are assessed using the Cognitive Emotion Regulation Questionnaire (CERQ), a 36-item self-administered questionnaire comprising nine subscales. Items are rated from 1 (almost never) to 5 (almost always), providing scores for adaptive and maladaptive cognitive emotion regulation strategies
Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Depressive Symptom Severity Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS
Periodo de tiempo: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Depressive symptom severity is assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). The scale consists of 10 items assessing depressive symptoms, each rated from 0 to 6. The total score ranges from 0 to 60, with higher scores indicating greater severity of depressive symptoms.
Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Change in Cognitive Flexibility Assessed by the Trail Making Test (TMT)
Periodo de tiempo: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Cognitive functioning is assessed using the Trail Making Test (TMT). The test includes Part A and Part B. Performance is assessed using the time required to complete each part, with longer completion times indicating poorer performance.
Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Change in Subjective Vitality Assessed by the Subjective Vitality Scale
Periodo de tiempo: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Subjective vitality is assessed using the Subjective Vitality Scale. The scale consists of 5 items rated from 1 to 7 and assesses the participant's subjective experience of physical and psychological energy and vitality. Higher scores indicate greater subjective vitality
Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
Change in Mood States Assessed by the Profile of Mood States (POMS-F)
Periodo de tiempo: Immediately before and immediately after each adapted physical activity session
Mood states are assessed using the French version of the Profile of Mood States (POMS-F), a 65-item self-administered questionnaire. The questionnaire assesses seven transient and fluctuating mood dimensions: tension-anxiety, anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, vigor-activity, and interpersonal relations. Items are rated on a 5-point Likert scale. An overall psychological distress score is calculated by summing the tension-anxiety, anger-hostility, confusion-bewilderment, depression-dejection, and fatigue-inertia scores and subtracting the vigor-activity score. Higher psychological distress scores indicate greater mood disturbance. Mood state is assessed using the French version of the Profile of Mood States (POMS-F). The POMS-F consists of 65 items rated from 0 (not at all) to 4 (extremely). The Global Score is calculated as the sum of Anxiety-Tension, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, and Fatigue-Inertia scores
Immediately before and immediately after each adapted physical activity session

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

  • Longuechaud C, Videau Villeneuve F, Bulteau F, Valot I, Douet M, Bulteau S, Deschamps T, Sauvaget A. The effect of adapted physical activity programs on the regulation of emotions in people suffering from major depressive disorders after hospital discharge: REAPAD study protocol. Minerva Psychiatry. 2026;67(2):82. doi:10.23736/S2724-6612.26.02669-2.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de febrero de 2023

Finalización primaria (Actual)

30 de abril de 2026

Finalización del estudio (Actual)

30 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

19 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de agosto de 2026

Publicado por primera vez (Actual)

21 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2022-A02099-34

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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