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

2016年3月9日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

86

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Berlin、德国、10117
        • Charité Universitätsmedizin Berlin - Departement of Psychiatry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in physical activity - objective
大体时间: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
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Change in self-efficacy
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Andreas Ströhle, Prof.、Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
  • 首席研究员:Moritz B Petzold, Dipl.Psych.、Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年4月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2015年10月2日

首先提交符合 QC 标准的

2015年10月5日

首次发布 (估计)

2015年10月7日

研究记录更新

最后更新发布 (估计)

2016年3月10日

上次提交的符合 QC 标准的更新

2016年3月9日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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