- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02569619
Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders (GAF)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Charité Universitätsmedizin Berlin - Departement of Psychiatry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿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 |
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Experimental: 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.
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Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in physical activity - objective
Periodo de tiempo: From baseline (T1) to 3 month after the intervention (T3)
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Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in physical activity - subjective
Periodo de tiempo: From baseline (T1) to 3 month after the intervention (T3)
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Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)
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From baseline (T1) to 3 month after the intervention (T3)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in self-efficacy
Periodo de tiempo: From baseline (T1) to 1 week after the intervention (T2)
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Self-efficacy is measured using two likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in intention for physical activity
Periodo de tiempo: From baseline (T1) to 1 week after the intervention (T2)
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Intention for physical activity is measured using two likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in self concordance of the motivation for physical activity
Periodo de tiempo: From baseline (T1) to 1 week after the intervention (T2)
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Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in outcome expectancies for physical activity
Periodo de tiempo: From baseline (T1) to 1 week after the intervention (T2)
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Outcome expectancies for physical activity are measured using 6 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in planning for physical activity
Periodo de tiempo: From baseline (T1) to 1 week after the intervention (T2)
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Planning for physical activity is measured using 4 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in barrier planning for physical activity
Periodo de tiempo: From baseline (T1) to 1 week after the intervention (T2)
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Barrier planning for physical activity is measured using 4 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in psychopathological symptoms
Periodo de tiempo: From baseline (T1) to 3 month after the intervention (T3)
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Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in health-related quality of life
Periodo de tiempo: From baseline (T1) to 3 month after the intervention (T3)
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Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in dietary behavior
Periodo de tiempo: From baseline (T1) to 3 month after the intervention (T3)
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Dietary behavior is measured using the Food Frequency Questionnaire (FEL)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in consumption of portions of fruit and vegetable per day
Periodo de tiempo: From baseline (T1) to 3 month after the intervention (T3)
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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
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From baseline (T1) to 3 month after the intervention (T3)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Andreas Ströhle, Prof., Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
- Investigador principal: Moritz B Petzold, Dipl.Psych., Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
Publicaciones y enlaces útiles
Publicaciones Generales
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Hardt J, Gerbershagen HU. Cross-validation of the SCL-27: a short psychometric screening instrument for chronic pain patients. Eur J Pain. 2001;5(2):187-97. doi: 10.1053/eujp.2001.0231.
- Winkler G, Doring A. Validation of a short qualitative food frequency list used in several German large scale surveys. Z Ernahrungswiss. 1998 Sep;37(3):234-41. doi: 10.1007/pl00007377.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GAF-1
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