Personalised Exercise Prescription: the Efficiency of a Transdisciplinary Blended Intervention in Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Psychosocial and occupational functioning
研究概览
简要总结
The purpose of the present study is to evaluate the changes on mental and physical health deriving from a blended intervention merging psychological intervention aimed at increasing activity and exercise with a personalised exercise program based on medical assessment on subjects suffering from mild to moderate depressive symptoms irrespective of diagnostic entity, by comparing two experimental groups (A. Personalised exercise group program+ app with motivational messages + fitness tracker or B. Personalised exercise group program+ app with no motivational messages + fitness tracker) and a control group (app with no motivational messages +fitness tracker). This study also introduces the use of a wearable device to collect information regarding physical activity and sleep patterns to provide motivational messages.
The investigators hypothesise that participation in a brief app-blended group intervention -on top of usual care- promoting personalised exercise and activity will improve functioning and well-being of participants, as well as motivate them to increase their physical activity and enhance behavioural changes towards a healthier lifestyle when compared to general exercise prescriptions. In addition, the investigators hypothesise that amongst patients who had been allocated to the intervention conditions, those presenting better commitment to prescribed personalised exercise plans (understood as more than a 70% compliance of prescribed exercise, measured by objective movement data collected by a fitness tracker) will show a higher functionality improvement.
详细描述
OBJECTIVE
Primary:
·To evaluate the changes on functioning deriving from a blended intervention merging psychological intervention aimed at increasing activity and exercise with a personalised exercise program based on medical assessment on subjects suffering from mild to moderate depressive symptoms.
Secondary:
- To test the differential effect of the above-mentioned blended exercise program on wellbeing, depressive symptoms and physical activity performance of patients with depressive symptoms, by comparing the three study arms.
- To measure wellbeing of patients allocated to the personalised exercise program, compared to the group condition.
- To assess and compare antidepressive response within both groups and intra subject at interim visits and final assessment.
- To measure effects of a personalised exercise program on exercise capacity and strength.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
After assignment to study conditions, participants and investigators will be blinded to one aspect of the specific experimental intervention (receiving or not motivational messages). Both will know whether participants have been allocated to experimental or control conditions but the specific experimental intervention (A or B) will not be revealed. To avoid assessment bias, an independent evaluator blinded to group allocation will complete follow-up assessments.
Clinicians, principal investigators, and statisticians will be also blinded to the randomization procedure and group allocation.
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
- •Aged >18-<65 years
- •Presenting mild to moderate depressive symptoms according to Montgomery-Asberg Depression Rating Scale (MADRS score>16 & <34)
- •Currently owning an Android compatible smartphone
- •Fluent in the Spanish language
- •Basic knowledge and skills using information and communication technology
- •Be able to provide written informed consent to participate
排除标准
- •Severe cognitive and/or physical impairment
- •Cognitive deficit or developmental disorder
- •Current psychotic, melancholic, or catatonic features
- •Drug or alcohol abuse
- •Modification of drug treatment (or its dose) in the last month (or plan for it
- •Beginning of psychological treatment in the last month
- •Beginning of biophysical treatment in the last month
- •Physical disability.
结局指标
主要结局
Psychosocial and occupational functioning
时间窗: Baseline, 4 weeks, 12 weeks, and 36 weeks.
The Functioning Assessment Short Test (FAST) will be used to assess the change in psychosocial and occupational functioning comparing subjects allocated to both experimental conditions (A+B) vs the control condition. The FAST is a simple self-administered instrument that comprises 24 items. It assesses impairment or disability in six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.
次要结局
- Depressive symptomatology(Baseline, 4 weeks, 12 weeks, and 36 weeks.)
- Well-being(Baseline, 4 weeks, 12 weeks, and 36 weeks.)
- Exercise motives(Baseline to week 36.)
- Physical and social functioning(Baseline, 4 weeks, 12 weeks, and 36 weeks.)
研究者
Francesc Colom
Group leader and senior researcher
Hospital del Mar Research Institute (IMIM)