A Randomized Pilot Study Comparing Vigorous Group Aerobic Exercise vs. Group Leisure Activities for Mild to Moderate Depression in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Children's Depression Rating Scale- Revised (CDRS-R)
研究概览
简要总结
The aim is to evaluate aerobic group exercise versus leisure group activities in adolescents with mild to moderate depression.
Primary outcome is Children's Depression Rating Scale - Revised (CDRS-R). Secondary outcomes are Clinical Global Impressions - Severity and Improvement scales (CGI), self-reported Quick Inventory of Depression Symptomatology (QIDS- A17-SR), the self-reported Outcome Rating Scale (ORS), clinician rated Children Global Assessment Scale (C-GAS), aerobic capacity (VO2max), muscular strength, body, Body Mass Index (BMI), presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples and a cost evaluation rated by parents with Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (Tic-P). Further objectives are qualitative interviews to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced and a validation of QIDS- A17-C and QIDS- A17-SR versus CDRS-R will be performed.
详细描述
Detailed Description: Depression is common in adolescence and prevalence is increasing. It is a major cause of disability in adolescents worldwide and contributes to lower educational achievements, increased risks of substance abuse, suicide and a risk factor for cardiovascular disease. The effect of evidence based treatments with antidepressants or psychotherapy such as cognitive behavioural therapy (CBT) or interpersonal therapy (IPT) are modest. Selective serotonin uptake inhibitors (SSRIs) have shown effect on depression in children and adolescents, but the effect is often insufficient.
Aerobic exercise seems to have effect on depression in adolescents but studies have several shortcomings. Recruitment was mostly in non-clinical or primary care facilities, results are heterogeneous and adequate control groups are lacking. More data on qualitative, cost-effectiveness and biomarker aspects are clearly warranted.
Objectives
- Primary objective To evaluate aerobic group exercise versus leisure group activities on clinician rated depression symptoms among adolescents in child and adolescent outpatient care with mild to moderate depressive disorder by measuring changes in Children's Depression Rating Scale- Revised (CDRS-R).
- Secondary objectives Secondary objectives are clinician rated Clinicial Global Impression - Severity (CGI-S) and Improvement scales (CGI-I) and function with Children Global Assessment Scale (C-GAS), self-rated symptoms (QIDS-A17-SR) and function with the Outcome Rating Scale (ORS), aerobic capacity measured by a submaximal aerobic capacity test, muscular strength measured by the isometric mid-thigh pull strength test, a hand grip strength test and muscular endurance by the one-leg sit-to-stand test, and body composition with a bioelectrical impedance analysis and presence or activity of selected biological markers of neuroprotection and neuroinflammation in blood samples.
Moreover, the investigators will assess cost-effectiveness in this trial. Another secondary objective is to explore adolescents' experiences of the intervention as well as how their health and lifestyle are influenced by the intervention through qualitative interviews. Finally, we will validate the QIDS- A17-C and QIDS-A17-SR against CDRS-R.
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)
盲法说明
The baseline and outcome assessor is not working at the clinic and is not informed of treatment mode. The patient is informed at the beginning of the interview not to disclose any information about mode of treatment. All interviews are recorded.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 mild to moderate depression
- •Who have received evaluation and basic psychosocial interventions for 4-8 weeks (minimum four visits) without response, i.e. not achieved improvement by at least 50 % as assessed from clinical records
排除标准
- •Eating disorder
- •High risk for suicide
- •Intellectual disability
- •Actual physical activity the last four weeks meeting the level for sustained health by American College of Sports Medicine, i.e. at least 150 min per week of moderate intensity or 75 min per week of high intensity38
- •Adjustment of antidepressant medication within the last four weeks or stimulants the last two weeks
- •Chronic somatic illness precluding exercise
- •In need of interpreter
- •Social circumstances interfering with a regular exercise schedule
- •Concomitant psychotherapy
研究组 & 干预措施
Aerobic exercise in group
The patients will participate in aerobic group exercise for 60 minutes three times a week for 12 weeks with continuous heart rate monitoring. The sessions will be held in a small gym under supervision of a personal trainer with special training in medical issues. The exercise will be monitored with continuous heart rate registration.
The group training session will begin with a warm-up to increase heart rate including balance tasks and dynamic stretching for 10-15 minutes. Every third session will be pure aerobic training, every third session will be strengthening exercises designed to also increase heart rate, and every third session will be a mixed session of both aerobic and strength exercises. All major muscle groups will be used at each session. Interval training with gradually increased intensity throughout the program will be applied.
干预措施: Aerobic exercise in group (Behavioral)
Group sessions with leisure activities
The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or watching movies together.
干预措施: Group sessions with leisure activities (Behavioral)
结局指标
主要结局
Change in Children's Depression Rating Scale- Revised (CDRS-R)
时间窗: After intervention (at 13 weeks) and at follow-up (at 52 weeks)
Clinician administered interview about symptoms of depression, range 17 (best) - 113 (worst)
次要结局
- Change in Outcome Rating Scale (ORS)(Every two weeks during the 12 week intervention and monthly during the preceding year.)
- Change in Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-A17-SR)(Every two weeks during the 12 week intervention and monthly during the preceding year.)
- Change in Muscular strength(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Children Global Assessment Scale (C-GAS),(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Aerobic capacity(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in Biological markers of neuroprotection and neuroinflammation in blood samples(After intervention (at 13 weeks) and at follow-up (at 52 weeks))
- Change in costs with the Treatment Inventory of Costs in Psychiatric Patients (Tic-P)(After intervention (at 13 weeks) and at follow-up (at 52 weeks))