- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07780695
Effect of Adapted Physical Activity on Emotion Regulation in People With Depressive Disorders (REAPAD)
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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Vendée
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La Roche-sur-Yon, Vendée, Francja, 85 000
- EPSM de Vendée - Centre Hospitalier Georges Mazurelle
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Classical Adapted Physical Activity
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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.
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Eksperymentalny: Combined Adapted Physical Activity Program
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in emotion regulation strategies assessed by the Cognitive Emotion Regulation Questionnaire (CERQ
Ramy czasowe: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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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
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Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Depressive Symptom Severity Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS
Ramy czasowe: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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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.
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Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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Change in Cognitive Flexibility Assessed by the Trail Making Test (TMT)
Ramy czasowe: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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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.
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Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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Change in Subjective Vitality Assessed by the Subjective Vitality Scale
Ramy czasowe: Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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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
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Baseline (T0), immediately after completion of the 6-week intervention (T1), and 6 weeks after the end of the intervention (T2)
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Change in Mood States Assessed by the Profile of Mood States (POMS-F)
Ramy czasowe: Immediately before and immediately after each adapted physical activity session
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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
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Immediately before and immediately after each adapted physical activity session
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Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2022-A02099-34
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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