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Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders (GAF)

9 mars 2016 mis à jour par: Moritz Petzold, Charite University, Berlin, Germany

Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders: Motivational Determinants of Adherence, Effect on Cognitive Determinants of Physical Activity, Physical Activity, Sitting Time and Clinical Symptoms

The purpose of this study is to determine if a manualised intervention to promote physical activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of everyday physical activity.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The Intervention program MoVo-LISA is a psychological intervention that should help participants to increase their level of physical activity for a healthy lifestyle.It contains three sessions (2 group,1 one on one) in the course of two weeks. The intervention focuses on planning and barrier management.

Participants develop activity ideas, goals and plans that enable them to integrate physical activity in their everyday routine and how to shield their motivation against barriers and difficulties.The intervention has proven to be effective with patients with pain disorders in rehabilitation.

This study examines if the intervention if effective for psychiatric outpatients as well. The intervention is compared to an active control group that receives a similar program that is focusing on a healthy diet.

Participants are recruited in the outpatient departements of three hospitals in Berlin and Brandenburg (Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy; St. Hewdig Hospital Berlin - Departement of Psychiatry; Oberhavel Hospital Brandenburg, Departement of Psychiatry) and at local psychiatrists in Berlin. Individuals are recruited by posters and flyers in the waiting areas areas or by information of their doctor. Patients can contact the researcher and are, after checked for eligibility, invited to an information event, where they get detailed information on the program and the study. After the information event, participants give written informed consent.

The intervention takes place in the outpatient departements of the three hospitals.

Clinical information about diagnoses, medication and functioning is obtained by their doctors by mail after the patients released them from confidentiality.

The study is an explorative approach to test if the program is suited for psychiatric patients. A sample size of 50 participants that complete the program is planned.

All data is collected pseudonymised to protect the identity of the patients.

Type d'étude

Interventionnel

Inscription (Réel)

86

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne, 10117
        • Charité Universitätsmedizin Berlin - Departement of Psychiatry

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Over 18 years of Age
  • Patients in one of the psychiatric outpatients or at an local psychiatrist in Berlin
  • Mental illness (ICD-10: F1-F4)
  • No contraindications for physical activity
  • Able to understand german language

Exclusion Criteria:

  • Contraindications to physical activity
  • Acute suicidality

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Activity Intervention
The activity intervention is MoVo-LISA (Göhner & Fuchs, 2007). A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes. The patients develop aims for their health, ideas, how to reach these aims through physical activity and make detailed plans, how to implement activity in their everyday routine. Difficulties and barriers are discussed.
Comportemental: Activity Intervention
Comparateur actif: Healthy Diet Intervention
The healthy diet intervention is a modification of MoVo-LISA. A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes. The patients develop aims for their health, ideas, how to reach these aims through a healthy diet and make detailed plans, how to implement a healthy diet in their everyday routine. Difficulties and barriers are discussed.
Comportemental: Healthy Diet Intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in physical activity - objective
Délai: From baseline (T1) to 3 month after the intervention (T3)
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
From baseline (T1) to 3 month after the intervention (T3)
Change in physical activity - subjective
Délai: From baseline (T1) to 3 month after the intervention (T3)
Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)
From baseline (T1) to 3 month after the intervention (T3)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in self-efficacy
Délai: From baseline (T1) to 1 week after the intervention (T2)
Self-efficacy is measured using two likert scaled items
From baseline (T1) to 1 week after the intervention (T2)
Change in intention for physical activity
Délai: From baseline (T1) to 1 week after the intervention (T2)
Intention for physical activity is measured using two likert scaled items
From baseline (T1) to 1 week after the intervention (T2)
Change in self concordance of the motivation for physical activity
Délai: From baseline (T1) to 1 week after the intervention (T2)
Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items
From baseline (T1) to 1 week after the intervention (T2)
Change in outcome expectancies for physical activity
Délai: From baseline (T1) to 1 week after the intervention (T2)
Outcome expectancies for physical activity are measured using 6 likert scaled items
From baseline (T1) to 1 week after the intervention (T2)
Change in planning for physical activity
Délai: From baseline (T1) to 1 week after the intervention (T2)
Planning for physical activity is measured using 4 likert scaled items
From baseline (T1) to 1 week after the intervention (T2)
Change in barrier planning for physical activity
Délai: From baseline (T1) to 1 week after the intervention (T2)
Barrier planning for physical activity is measured using 4 likert scaled items
From baseline (T1) to 1 week after the intervention (T2)
Change in psychopathological symptoms
Délai: From baseline (T1) to 3 month after the intervention (T3)
Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
From baseline (T1) to 3 month after the intervention (T3)
Change in health-related quality of life
Délai: From baseline (T1) to 3 month after the intervention (T3)
Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)
From baseline (T1) to 3 month after the intervention (T3)
Change in dietary behavior
Délai: From baseline (T1) to 3 month after the intervention (T3)
Dietary behavior is measured using the Food Frequency Questionnaire (FEL)
From baseline (T1) to 3 month after the intervention (T3)
Change in consumption of portions of fruit and vegetable per day
Délai: From baseline (T1) to 3 month after the intervention (T3)
Consumption of fruit and vegetable is measured using two items asking for the number of portions of fruit and vegetable that are consumed on a regular day (a portion is defined as a hand full). Consumption of fruit and vegetable is then added to check if the WHO recommendation of "5 a day" is met
From baseline (T1) to 3 month after the intervention (T3)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Charite University, Berlin, Germany

Les enquêteurs

  • Directeur d'études: Andreas Ströhle, Prof., Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
  • Chercheur principal: Moritz B Petzold, Dipl.Psych., Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2014

Achèvement primaire (Réel)

1 mars 2016

Achèvement de l'étude (Réel)

1 mars 2016

Dates d'inscription aux études

Première soumission

2 octobre 2015

Première soumission répondant aux critères de contrôle qualité

5 octobre 2015

Première publication (Estimation)

7 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

10 mars 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 mars 2016

Dernière vérification

1 mars 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GAF-1

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