Physical Activity as Treatment for Depression and Anxiety Towards Affordable Preventive Healthcare - a Randomised Controlled Study (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Symptom improvement in anxiety
研究概览
简要总结
In a 12 week randomly controlled open trial 102 participants with symptoms of depression and/or anxiety will be exposed to either aerobic high intensity training (HIT) or relaxation therapy. Cognitive functions, biomarkers, psychiatric symptom scales and physical status will be collected at baseline, after 12 weeks and after a year. Depression and anxiety will be measured twice during the intervention period.
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
- 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
- •Score ≥12 on MADRS or score ≥16 on BAI
- •Inhabitant i Örebro County, Sweden
- •BMI ≥18 kg/m^2
排除标准
- •Diagnosis of chronic psychotic disease or ongoing psychotic episode.
- •Ongoing manic state of bipolar disorder
- •Severe somatic disease or condition where high intensity exercise is contraindicated
- •Difficulty with reading, hearing or understanding the Swedish language
结局指标
主要结局
Symptom improvement in anxiety
时间窗: Change of the score from the baseline to the score at 1 year.
Improvement of symptom severity grade are assessed with Beck Anxiety Inventory (BAI). The minimum and the maximum score is 0 and 63 respectively, and the higher score means a worse outcome.
Symptom improvement in depression
时间窗: Change of the score from the baseline to the score at 1 year.
Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale (MADRS). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.
Subjective symptom improvement in depression
时间窗: Change of the score from the baseline to the score at 1 year.
Improvement of symptom severity grade are assessed with Montgomery-Åsberg Depression Rating Scale Self-Rating Version (MADRS-S). The minimum and the maximum score is 0 and 60 respectively, and the higher score means a worse outcome.
次要结局
- Cognitive function: Trail Making Test Part A&B(Comparison of results between baseline and year 1.)
- Cognitive function: Corsi Block-Tapping Test forward(Comparison of results between baseline and year 1.)
- Cognitive function: Rey Auditory Verbal Learning Test(Comparison of results between baseline and year 1.)
- Cognitive function: Stroop test(Comparison of results between baseline and year 1.)
- Clinical Global Impression (CGI) severity scale(Up to 1 year from baseline.)
- EuroQol-Health-Related Quality of Life (EQ-5D-5L)(Up to 1 year from baseline.)
- Posttraumatic Stress Disorder Checklist (PCL-5)(Up to 1 year from baseline.)
- Adult ADHD Self-Report Scale (ASRS)(Up to 1 year from baseline.)
- Cognitive function: Symbol Digit Modalities Test(Comparison of results between baseline and year 1.)
- Perceived Stress Scale (PSS-14)(Up to 1 year from baseline.)
研究者
Yvonne Freund-Levi
Associate Professor, M.D., Ph.D
Region Örebro County