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临床试验/NCT01547026
NCT01547026已完成不适用

Self-regulation Strategies to Improve Exercise Behavior: A Randomized Clinical Trial in Persons With Schizophrenia Spectrum Disorders

University of Konstanz2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
percentage of sports therapy sessions attended

研究概览

简要总结

Patients who suffer from diseases of the schizophrenia spectrum are frequently burdened by weight gain. Sport programs have been shown to improve somatic and psychological health. However, the motivation to participate in sports therapy is usually impaired due to illness-related factors such as anhedonia and negative symptoms. Previous attempts to increase participation in sports therapy have used psycho-educational and behavioral attempts that require a lot of resources. In this study the investigators will use a brief method developed in experimental social psychology to build up implementation intentions. This method has been shown to improve psychological test performance in schizophrenia patients but has never been used in a clinical context.

In two psychiatric hospitals, in-patients with schizophrenia who have been examined by a medical doctor, for whom any medical concerns for sports therapy participation have been excluded and who declared their motivation to participate in an existing standard sports exercise program will be recruited for the study. After information on the study and signing of an informed consent patients will be randomly assigned to two treatment conditions. In the control condition, the main therapist will individually deliver a 10-minute psycho-education on the helpfulness of sports to improve the health; this will be repeated in a shorter form in the regular individual treatment sessions over the following weeks. The intervention condition will use a structured procedure of the same duration to build up implementation intentions to participate in the sports therapy. The implementation intentions will briefly be repeated and updated in the following session.

Primary outcome variables will be percentage of attended sport therapy sessions, persistence and compliance. Secondary outcome variables will be Body Mass Index. As confounding variables the investigators will assess amount of anti-psychotic medication in Chlorpromazine equivalents, negative and depressive symptoms, usual sport activities and cognitive impairments.

The investigators expect that building up implementation intentions will increase participation, persistence and compliance of the patients in the sports and exercise therapy program compared to the patients who just have received psycho-education.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • schizophrenia or schizo-affective disorder

排除标准

  • manic episode
  • florid positive psychotic symptoms
  • catatonic symptoms
  • medical concerns for possible damage to patients health by participation in sports therapy
  • patient is aggressive
  • patient is suicidal
  • epilepsia

结局指标

主要结局

percentage of sports therapy sessions attended

时间窗: max. 8 weeks

During a single patient's in-patient treatment, we count the number of sport therapy sessions that were attended and compute a ratio attended/offered sessions

Persistence

时间窗: max. 8 weeks

We assess whether a patient has persisted to participate in successive sports therapy session

Compliance

时间窗: max. 8 weeks

We assess how long the individual patient participates in each therapy session (standard duration 30 min.)

次要结局

  • Body Mass Index (BMI)(max. 8 weeks)

研究者

发起方
University of Konstanz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Odenwald

Chief Psychologist of the Schizophrenia Research Ward

University of Konstanz

研究点 (2)

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