Avaliação de Uma intervenção de promoção Atividade física em Pacientes Com depressão Maior em Atendimento Ambulatorial (MOVEDEP): um Ensaio clínico Randomizado
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Depressive symptoms (blinded assessment)
研究概览
简要总结
Randomized clinical trial that aims to increase physical activity levels in people with depression and to evaluate if the increase on PA levels has impact on clinical and biological measures.
详细描述
The contacts will be made by face-to-face interviews and telephone calls
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 18 - 65 years;
- •diagnosis of Major Depressive Disorder (DSM-IV), assessed by a trained psychiatrist;
- •score 7 or more in the HAM-D;
- •do not present clinical comorbidities that limit or contra-indicate the practice of physical activity;
- •be starting depression treatment at the Programa de transtorno do humor (PROTHUM) ;
- •have acess to a computer and have a facebook account;
- •be able to read and sign the consent term.
排除标准
- •present other psychiatric diagnosis such as bipolar disorder, schizophrenia or use of alcohol or other drugs;
- •be not liberated to the practice of physical exercises by the assistant psychiatrist.
研究组 & 干预措施
Physical activity promotion + TAU
Physical activity promotion based on:
- Pedometers use;
- Weekly contact (telephone or face-to-face);
- Contact based on a self-determination theory.
TAU:
Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.
干预措施: Physical activity promotion + TAU (Behavioral)
Control
Weekly calls with general health content.
TAU:
Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.
干预措施: Control (Behavioral)
结局指标
主要结局
Depressive symptoms (blinded assessment)
时间窗: At the end of the intervention (6 months)
Hamilton scale for depressive symptoms assessed by a blinded psychiatrist. Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher scores means higher depressive symptoms. The cutoffs are the following: following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24). The maximum score is 52.
次要结局
- Depressive symptoms (self-reported)(At the end of the intervention (6 months))
- Quality of life(At the end of the intervention (6 months))
- Physical activity - self-report(At the end of the intervention (6 months))
- Physical activity levels - objective measure(At the end of the intervention (6 months))
- Melancholia(At the end of the intervention (6 months))
- Weight(At the end of the intervention (6 months))