Development, Testing and Implementation of a Physical Activity Intervention for Youth With Anxiety and Depression -Confident, Active and Happy Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Objective measure of activity change
研究概览
简要总结
Prevalence of mental health problems and disorders in children and adolescents (hereafter youths) are estimated at 13.4% of which anxiety and depressive disorders account for more than half of these disorders. These rates are increasing, putting a large strain on child and adolescent mental healthcare services (CAMHS) to provide cost-effective treatments with documented long-term effects. However, even when provided the best evidence based treatment, between 40-50 % do not recover and continue to report significant symptom burdens. Thus, there is an immediate need for supplementary and/or new treatment approaches. Physical activity as a supplementary treatment may be one such approach. However, research investigating this approach within this population is scant. This protocol paper describes the development and feasibility trial of a physical activity based intervention targeting anxiety and depressive symptoms in youth.
The current study will be based on the UK Medical Council Research Framework (MRC) for developing and evaluating complex interventions. The study will initially focus on the first two phases of the MRC framework. In line with phase one of this framework, key intervention components have been identified in preliminary work, which draw on the effects of moderate to vigorous physical activity, inhibitory learning theory and self determination theory. These components are to be developed into an intervention to be used in CAMHS. Twenty youths with anxiety and/or depressive symptoms will be recruited to the intervention. Physical activity will be measured using the Actigraph GT3X+ monitor at baseline and post-intervention. Outcome measures concerning symptom change will be assessed (anxiety and depression). Semi-structured qualitative interview with participants, caregivers and referring specialists will help identify possible contextual and practical factors associated with delivery of the intervention and explore acceptability of assessment procedures, the intervention, and perceived benefits and barriers to participation.
This study will contribute to the development of evidence-based, patient-informed supplementary physical treatment interventions for youth with internalizing disorders in contact with CAMHS. The goal is to examine new avenues of treatment that ultimately may improve upon current treatment outcomes of these disorders.
详细描述
In order for health authorities to be able to respond to the current high demand on mental health services in youth, current treatment interventions need to be examined. The need for augmented and/or supplementary interventions is pressing. Physical activity appears to be a promising, low-risk intervention that may serve this purpose and provide long-term protective health benefits. Despite the potential gain from including physical activity in CAMHS treatments, to our knowledge, no previous study has examined the use of a physical activity program in CAMHS as a supplementary treatment in youth's with anxiety and/or depression. Furthermore, there is a paucity of studies of high methodologically quality examining this topic.
It is the aim of the current study to address this shortcoming by developing a theoretically based physical activity intervention to supplement existing treatment for youth with internalizing disorders (Confident, Active and Happy Youth: CAH-Y).
The current research and intervention development will be based on the UK Medical Council Research Framework (MRC) for developing and evaluating complex interventions.
The MRC framework strongly recommends carrying out feasibility testing prior to any full-scale trial. In line with this recommendation and phases, one and two of the MRC framework, this study proposes to develop and examine the feasibility of recruitment, retention and acceptability of a physical activity intervention for youth with anxiety and/or depression treated in CAMHS. This work will lay the groundwork for later phases and a definitive RCT.
Methods Development of the intervention The theoretical framework for the CAH-Y intervention will draw on three theories. While not a unified theory, the evidence on the psycho-physiological effect of moderate to vigorous physical activity in regards to mood and anxiety disorders in youth specifically and youth mental health in general, indicates a plethora of causal pathways and positive effects. Primarily modulation of monoamines (e.g., increase in serotonin levels), and HPA axis regulation are assumed to be of importance in relation to anxiety and depression. Secondly, Self Determination Theory is a framework with which to understand participant experiences with physical activity and their motivation towards physical activity. The framework focuses on intervention components that can enhance learning and intrinsic motivation concerning both increased activity and behaviour and symptom change. Regarding motivation, evidence suggests that in order to establish physical activity behaviour change, individuals must be either in the 'preparation' or in the beginnings of an 'action' stage of change. Thus, in order to increase physical activity, it is critical that participants are engaged and ready to change behaviour. The final theoretical foundation is inhibitory learning theory which provides a generic framework to understand the bi-directional interaction between cognition, affects and behaviour in regards to anxiety and depression and in particular the role of (physical activity) avoidance as a contributor to and a maintaining factor in these disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8- 17 years
- •Symptoms of anxiety and/or depression
- •Youth display reduced daily physical activity (less than 30 mins. pr. day and/or does not partake in physical leisure activities, and/or does not participate in physical education in school).
- •The youth is motivated to partake in physical activity
排除标准
- •Physical activity is not advised for medical reasons
- •Severe learning disabilities and the youth is unable to understand the study protocol
- •Specific psychiatric disorders including any eating disorder, psychosis
- •Severe challenging behavior or other needs requiring constant one to one support
结局指标
主要结局
Objective measure of activity change
时间窗: Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term)
Actigraph measurement of youth activity level
Retention rate (number of sessions youth completed before their last session)
时间窗: From start of treatment to end of treatment (7 weeks)
These descriptive data provide information concerning the feasibility of the program. Retention rate is defined as the number of participants who remained in the study, i.e. the number of participants who did not drop out.
Anxiety symptom change
时间窗: Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term)
Spence Child Anxiety Scale, child and parent version (SCAS-C/P). The measure assesses youth anxiety symptoms. The SCAS-C/P comprises 38 items rated on a 4-point scale (0 = never, 1 = sometimes, 2 = often, 3 = always), with possible a minimum score of 0 and possible a maximum score of 114. High scores indicate higher anxiety levels, and lower scores indicate lower anxiety levels.
Affective symptom change
时间窗: Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term)
Short Mood and Feelings Questionnaire, child and parent version (SMFQ-C/P). The measure assesses youth depressive symptoms. The SMFQ consists of 13 items rated on a 3-point scale (0 = not true, 1 = sometimes true, 2 = true), with possible a minimum score of 0 and possible maximum score of 26.Higher scores indicate greater severity of depressive symptoms.
Recruitment rate (number of youth referred/number of youth assessed as eligible).
时间窗: Pre-treatment
These descriptive data provide information concerning the feasibility of the program. Tracking of participant recruitment (number of youth referred/number of youth assessed as eligible), Rates will be presented in percent.
Attendance rate (total number of sessions youth attend)
时间窗: From start of treatment to end of treatment (7 weeks)
These descriptive data provide information concerning the feasibility of the program. Attendance to the intervention was measured by counting how many sessions each participant attended and then dividing it by the total number of exercise sessions. Attendance is presented as a percent.
次要结局
- Key-process-related outcome e.g how did the participant experience the treatment.(Through study completion, an average of 1 year)
