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

1. Introduction 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 and somatic healthcare. Children and adolescents with depression and anxiety symptoms are significantly less physically active than their non-affected peers (Mangerud, Bjerkeset, Lydersen, & Indredavik, 2014). 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 (Firth et al., 2019). Physical activity is proven to be a low-cost, highly acceptable, non-stigmatizing intervention with no negative side-effects (Firth et al., 2019). 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 (Carter et al., 2021; Recchia et al., 2023). 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 (H.dir 2024). This translates to less service utilization (i.e. hospital and community services) (Firth et al. 2020). 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 (Cahill, Egan, & Seber, 2020). 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 (Kearney, 2008). These outcomes represent a substantial societal challenge, one that the Norwegian government is actively working to address (St.meld. 32). 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 (Tomporowski, Lambourne, & Okumura, 2011). 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 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 (Hickingbotham et al., 2021). 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 (Haran, Killeen, Smyth, & McNicholas, 2024), 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 (Haran et al., 2024). Sample-sizes among included studies were low, many studies did not include control groups, and very few studies included assessment of psycho-social functioning (Haran et al., 2024). These limitations severely curb the conclusions that may be drawn and there is a lack of rigorous research on the topic. Confident, Active and Happy Youth Intervention Department of Child and Adolescent Mental Health Services (CAMHS), Haukeland University Hospital has in collaboration with users, developed and piloted a PA-based supplemental treatment, termed Confident, Active and Happy Youth (CAHY) (Kodal et al., 2024; Kodal et al., 2022). The intervention targets youth with heightened symptoms of depression and anxiety. The intervention targets the core characteristics of depression and anxiety which constitute the barriers towards engaging in PA and social participation in the affected youth. The intervention addresses and accommodates the patients' -often ambivalent- motivation, lowered mood, high levels of avoidance and low levels confidence to engage in activities they seek to avoid. Youth are dependent on their context and most importantly their families, given that family support can be both a barrier and facilitator of PA in youth (O'Connor, Jago, & Baranowski, 2009). Thus, to enhance youth’s adherence to physical activity and foster social participation during and after the intervention, parent follow-up is incorporated in the intervention. A feasibility study on CAHY was conducted in 2021-2022, detailed in three published papers (Anker, Bøe Sture, Hystad, & Kodal, 2024; Kodal et al., 2024; Kodal et al., 2022). The intervention was found to be feasible in a clinical setting, highly acceptable by youths and parents and was associated with no adverse events. Willingness to participate was high (84%) and treatment retention rate was high (89%). Depressive and anxiety symptomatic changes were small following the intervention, however both youth and parents reported positive functional outcomes, including increased confidence, increased school attendance, increased physical activity and increased social participation. 1.1. Impact on Patient Care The intervention's is a new supplemental addition to current treatment options in child and adolescent mental health (CAMHS). As such, the intervention may reach children and adolescents, that do not respond sufficiently to current approaches (psychotherapy and/or psychopharmacology). Furthermore, the treatment offers a safe training arena for youths’ barriers to engage in social participation and PA, which in many ways resembles arenas they are expected to participate in, outside the clinic. Such an arena does not exist per today in clinic and will likely strengthen treatment gains outside the clinic. The intervention does not rely on specialized mental-health professionals but can be delivered by other non-specialized health-care professionals, thus bypassing current staff recruitment challenges in child and adolescent mental health services (CAMHS). If proven effective and youth experience symptomatic remission faster, this frees capacity in CAMHS, which may be allocated to patients that need it the most. From a health-care provider perspective, this is a highly relevant: patient numbers are expected to rise, and economic and human resources are limited. Establishing more effective treatment paths is vital to meet these future challenges. By targeting functional outcomes and social participation, the CAHY intervention is poised to address the broader psychosocial challenges that young patients with depression and anxiety often face, such as social isolation, school absenteeism and ultimately social exclusion. Incorporating physical activity into treatment could offer a more holistic approach to care which also enables and empowers the youth to manage their own symptoms and impairments. This can incrementally add to a more positive health trajectory for them. If proven efficacious, this treatment approach, has applications beyond the included patients – many groups of children with mental and somatic health related problems and disorders demonstrate similar barriers towards physical activity and social participation, including congenital heart disease, and children born premature (Engan et al., 2020; Gonzalez et al., 2021). Finaly, given our study is done in a real-world setting, transferability of results to clinic is particularly low. 2. Objectives and Goals/Milestones of the Project Objectives and/or hypotheses It is the goal of this study, to establish the effectiveness of the Confident, Active and Happy Youth intervention, as a supplemental treatment for youth with elevated depressive and anxiety symptoms receiving treatment in Child and Adolescent Mental Health Care (CAMHS). The study will be conducted as a pragmatic rand