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临床试验/NCT02569619
NCT02569619已完成2 期

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

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
86
试验地点
2
主要终点
Change in physical activity - objective

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Contraindications to physical activity
  • Acute suicidality

结局指标

主要结局

Change in physical activity - objective

时间窗: From baseline (T1) to 3 month after the intervention (T3)

Physical activity is objectively measured using accelerometry (ActiGraph GT1M)

Change in physical activity - subjective

时间窗: From baseline (T1) to 3 month after the intervention (T3)

Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)

次要结局

  • Change in planning for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in health-related quality of life(From baseline (T1) to 3 month after the intervention (T3))
  • Change in consumption of portions of fruit and vegetable per day(From baseline (T1) to 3 month after the intervention (T3))
  • Change in self-efficacy(From baseline (T1) to 1 week after the intervention (T2))
  • Change in barrier planning for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in dietary behavior(From baseline (T1) to 3 month after the intervention (T3))
  • Change in intention for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in self concordance of the motivation for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in outcome expectancies for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in psychopathological symptoms(From baseline (T1) to 3 month after the intervention (T3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moritz Petzold

Dipl.Psych. Moritz Petzold

Charite University, Berlin, Germany

研究点 (2)

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