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

21 de agosto de 2026 atualizado 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.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

45

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in emotion regulation strategies assessed by the Cognitive Emotion Regulation Questionnaire (CERQ
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Depressive Symptom Severity Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Publicações Gerais

  • 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.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de fevereiro de 2023

Conclusão Primária (Real)

30 de abril de 2026

Conclusão do estudo (Real)

30 de abril de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

19 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de agosto de 2026

Primeira postagem (Real)

21 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2022-A02099-34

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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