Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 9
- 主要终点
- Change in depressive symptoms - clinician rated
研究概览
简要总结
The purpose of this study is to determine if the use of pedometers can help depressive inpatients in psychiatric clinics to increase their level of physical activity. Therefore patients are given a pedometer and instructions how to raise their level of daily steps. Intervention group is compared with a control group that is receiving treatment-as-usual. The intervention is hypothesized to increase number of daily steps and have positive effects on mood, depression and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depression, moderate to severe as main diagnosis
- •Inpatient status
- •Prospected inpatient treatment of at least 4 weeks
- •Able to understand german
排除标准
- •Physical disease or disability that makes it impossible to reach the goal 5000 steps per day
- •Borderline personality disorder
- •Bipolar Disorder
- •Schizophrenia
- •Anorexia Nervosa
- •Psychotic Depression
- •Pregnancy
- •Acute suicidality
- •Substance dependancies with actual consumption (except nicotine)
- •Current pedometer-use
- •More than 10.000 steps per day
研究组 & 干预措施
Intervention group
Patients receive a pedometer and instructions how to raise their physical activity
干预措施: Pedometer (Device)
Control group
Patients receive treatment-as-usual
结局指标
主要结局
Change in depressive symptoms - clinician rated
时间窗: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Depressive symptoms are rated by a blind study employee using MADRS
Change in average number of steps per day
时间窗: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Number of steps per day is objectively measured using accelerometry (ActiGraph GT1M)
次要结局
- Change in health-related quality of life(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in psychopathological symptoms(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in self-efficacy for physical activity(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Duration of inpatient treatment (Number of days)(Duration of inpatient treatment is assessed at the end of inpatient treatment)
- Change in physical activity - objective(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in self concordance of the motivation for physical activity(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in anxiety symptoms(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in outcome expectancies for physical activity(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in planning and barrier planning for physical activity(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in general self-efficacy(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in physical activity - subjective(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in depressive symptoms(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- Change in intention for physical activity(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
研究者
Prof. Dr. Andreas Ströhle
Prof. Dr. med.
Charite University, Berlin, Germany