The Impact of Running Therapy on Mental Health of Youth in the In-patient and Daycare Centers of the Psychiatric Adolescent Department, Ziv Medical Center, Safed - A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in depressive symptoms
研究概览
简要总结
A randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. The control group will continue the treatment program as usual.
详细描述
Patients in the inpatient and daycare centers of the psychiatric adolescent department at Ziv Medical Center receive an intensive treatment program including medical management, psychotherapy (individual, groups, and family therapy), and suited educational and other extracurricular recreational activities. Despite growing evidence of the effective influence of aerobic physical activity and running therapy, it is not included in the intensive treatment program, and, as far as we know, it is not included in most psychiatric wards in Israel.
The aim of this study is to assess the effectiveness of combining a group based running therapy as part of the treatment program provided in the inpatient and day care centers of the psychiatric ward.
A randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. The control group will continue the treatment program as usual.
Participants will have group running sessions for 1 hour, three times a week, for 12 weeks. Sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. The sessions will be at an open court near the hospital. It will be guided by a team that will address both physical and therapeutic aspects.
The intervention program will include running outside the hospital complex (Safed Stadium) 3 times a week for about an hour each time, for 12 weeks. Participants will be transported to the stadium in an organized manner where the therapeutic running training will be conducted by a team that will include the researcher, running coach, nursing staff and psychology students.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-18-year-olds.
- •Expected to be under observation for at least 10 weeks at time of recruitment.
- •Consent of the patients and their parents to participate in the randomized control trial
排除标准
- •Acute psychosis or manic states
- •Acute suicidality
- •Extreme physical difficulties
- •Anorexia Nervosa
结局指标
主要结局
Change in depressive symptoms
时间窗: 1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)
Depressive status will be measured using the Children Depression Inventory (CDI; Kovacs, 1992) before and after the intervention to assess the change in symptoms.
Change in anxiety symptoms
时间窗: 1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention)
Anxiety level will be measured by Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1997, 1999) before and after the intervention to assess the change in symptoms.
次要结局
- Change in emotion regulation symptoms(1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention))
- Change in self-efficacy symptoms(1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention))
- Change in self compassion symptoms(1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention))
- self injurious behavior(1-2 weeks before the start of the intervention and at the end of the intervention (10-11 weeks after the start of the intervention))
研究者
Tali Bertler
Principal Investigator
Ziv Hospital