跳至主要内容
临床试验/NCT07304219
NCT07304219Enrolling By Invitation不适用

Physical Activity Based Treatment for Youth With Depression and Anxiety - a Pragmatic Randomized Controlled Trial

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
The Revised Child Anxiety and Depression Scale (RCADS)

研究概览

简要总结

The Confident, Active, and Happy Youth (CAHY) project aims to address the significant functional impairments experienced by youths with symptoms of depression and anxiety, focusing on physical activity (PA) and social participation. Traditional treatments, such as psychotherapy and pharmacotherapy, have shown moderate success, with many patients continuing to face functional and social challenges. This research seeks to fill that gap by testing the effectiveness of a physical activity-based intervention in a clinical setting to improve mental health and functional outcomes in clinical populations.

The study will be conducted as a pragmatic, randomized controlled trial, comparing CAHY with a waitlist control group in a real-world clinical setting. The intervention targets disease-specific barriers to PA and social participation, including fatigue, avoidance behaviors and low self-efficacy. The central challenge lies in adapting PA interventions to the clinical needs of youth with psychiatric disorders, which is essential for addressing the social and functional impairments associated with these disorders.

If proven effective, the results could have broad applications, offering a non-pharmacological treatment that is scalable and adaptable to various healthcare settings. The intervention supplements current treatment approaches and can improve patient outcomes in the short- and long-term, and can ultimately decrease healthcare service utilization by promoting better self-care and health habits

详细描述

The present research will examine the effectiveness of a novel supplemental intervention targeting children and adolescents with depression and anxiety symptoms. If proven efficacious, the research has broad applications in mental options; namely lack of physical activity, and interventions targeting functional outcomes in the form of social participation. and somatic healthcare.

Children and adolescents with depression and anxiety symptoms are significantly less physically active than their non-affected peers. Not only is PA vital to healthy development in children and adolescents, but low levels of physical activity are also significant risk factors for depression and anxiety, maintain, and aggravate these symptoms in children and adolescents. Physical activity is proven to be a low-cost, highly acceptable, non-stigmatizing intervention with no negative side-effects. Strong evidence indicates that physical activity is beneficial to mental health in youth in general and can be used in clinical populations towards mental health disorders such as depression and anxiety with moderate effect sizes. Towards long-term health trajectories, PA is a significant protective factor towards depression and anxiety specifically, mental and somatic diseases in general, and PA is also strongly related to overall lifespan. This translates to less service utilization (i.e. hospital and community services). Notably, PA is a modifiable factor in children and adolescents. However, PA is per today not included in treatment recommendations for youth mental health treatment (e.g. NICE guidelines) nor systematically used in child and adolescent treatment services.

Parallel to established knowledge of the health effects of adequate PA, social participation plays a crucial role in psychosocial development in children and adolescents. It fosters communication, empathy, teamwork, and conflict resolution, which are all vital skills in social settings and relationships including family, friendships, education, and work. Adolescents who are more socially engaged tend to have better long-term health trajectories (somatic and mental health), including higher levels of self-esteem, better social skills and well-being. Social participation is a primary factor in child and adolescents' functional level and youth with heightened depression and anxiety symptoms experience significant impairment in this area. Impairments in social participation are strongly linked to school absenteeism and dropout, loneliness, the development of chronic health conditions, and social exclusion. These outcomes represent a substantial societal challenge, one that the Norwegian government is actively working to address. Importantly, social participation is a modifiable factor and interventions specifically targeting this functional aspect of youths' mental health are limited.

Physical activity is commonly done in groups (i.e. football), and organized and non-organized physical activity (school or extracurricular) is a vital arena in terms of social training, social efficacy and social participation for children and adolescents. Thus, physical activity in groups provides a perfect platform and means to target depression and anxiety and address the social and functional impairments of depression and anxiety. Crucially, to unlock and make use of a physical activity based intervention in the treatment of youth depression and anxiety, it is paramount to address these youths disease- related barriers that deter them from using and joining in available physical and social opportunities, in their daily milieu. These barriers map onto the core symptoms of anxiety and depression; fatigue; low levels of physical activity; low confidence in one's ability to cope with situations that incite distress and/or fear; avoidance of engaging in situations that may incite distress and/or fear and lowered mood. For any intervention to be successful, it must specifically address and accommodate these barriers.

A major caveat with current research on physical activity and social participation falls on these barriers, which differentiates youth populations. Thus, findings from non-clinical populations with-out these barriers cannot be automatically taken to apply for clinical populations with these barriers. These is a paucity of studies examining the use of PA based interventions in clinical populations. Further, while a recent scoping-review of PA interventions in youth treated in child and adolescent mental health services (CAMHS) found evidence in support of the efficaciousness of PA towards depression and social participation, the review also indicated several limitations. Thus, numerous confounders were not controlled for including concurrent medication, co-morbid disorders, PA activity levels outside the intervention itself, and PA adherence in the intervention. Sample-sizes among included studies were low, many studies did not include control groups, and very few studies included assessment of psycho-social functioning. These limitations severely curb the conclusions that may be drawn and there is a lack of rigorous research on the topic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Randomization of participants is done by a random-number generator, and a mercantile ressource will allocate participants accordingly. Participants are not informed of the outcome of this randomization, and therapists providing the treatment are uanware of the randomization outcome.

The primary investigator and outcomes assessor will know the result of the randomization, but have noe influence on the outcome of the randomization itself or allocation of participants to either condition.

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to treatment for psychiatric disorder at the Child and Adolescent Mental Health Services at Haukeland University Hospital (Psykisk helsevern for barn og unge, Helse Bergen)

排除标准

  • The CAHY treatment is contraindicated (e.g. in severe eating disorders)
  • When participation would compromise the benefit for other patients in the group

研究组 & 干预措施

Treatment arm

Experimental

The Confident, Active and Happy-Youth intervention (CAHY), which is a group-based, bi-weekly, seven-week long, therapist-led intervention targeting core symptoms of anxiety and depression. Sessions are 50 mins. long, and offer a supportive, non-competitive, playful, and mastery-oriented climate to facilitate the individuals' need for relatedness, foster self-efficacy, motivation, fun and provide a safe space to practice exposure and gain positive experiences with social participation.Children and adolescents participate in age adjusted groups of max. eight: a child group age 8-10 years, a youngster group aged 11-3 years and adolescents group aged 14-17 years.

干预措施: Confident, Active and Happy youth (CAHY) (Behavioral)

Waitlist Control

No Intervention

Participants randomized to this condition does not receive the intervention during the waitlist period, but receives CAHY intervention after the intervention i completed in the intervention group. Similar to the treatment group, they are measured before and after the waitlist period.

结局指标

主要结局

The Revised Child Anxiety and Depression Scale (RCADS)

时间窗: From enrollment to follow-up three months after end of treatment

The Revised Children's Anxiety and Depression Scale-25 (RCADS-25) is a 25-item scale that measures levels of anxiety (e.g. "I worry when I think I have done poorly at something") and low mood (e.g. "I feel sad or empty"). The scale has two subscales (Total Anxiety and Total Depression) and an overall score.

次要结局

  • Kidscreen-27(From enrollment to follow-up three months after end of treatment)
  • Participation in community(From enrollment to follow-up three months after end of treatment)
  • Objective physical activity(From enrollment to follow-up three months after end of treatment)
  • Simple Physical Activity Questionnaire(From enrollment to follow-up three months after end of treatment)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arne Kodal

Researcher

NORCE Norwegian Research Centre AS

研究点 (1)

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