Physical Activity Based Treatment for Youth With Depression and Anxiety

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.

The 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). The intervention targets children and adolescents with mental health disorders receiving treatment in CAMHS. The intervention targets 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.

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 mental health disorders, depressive and anxiety symptoms receiving treatment in Child and Adolescent Mental Health Care (CAMHS).

The study will be conducted as a pragmatic randomized controlled study, comparing active treatment to waitlist control. The study is pragmatic in that it is conducted in a real-world setting. Our research project aims to answer the following research questions:

* To what extent is the 7-week CAHY intervention successful in instigating the expected decrease in depressive and anxiety symptoms. * What is the effectiveness of the CAHY-intervention towards instigating increased physical activity, increased social participation and quality of life in participants? * What is the effectiveness of a physical activity intervention as a supplement to regular treatment in youths in treatment in CAMHS? * What are the moderators of outcome for participants following a physical activity intervention?

The investigators hypothesize effects on the following primary outcomes compared to waitlist controls:

• Greater reduction in depressive and anxiety symptoms among participants.

The investigators hypothesize effects on the following secondary outcomes compared to waitlist controls:

* Improved quality of life and social participation. * Improved daily PA. * Improved social participation in community

The investigators expect intervention effects to be moderated by the following variables:

* Time spent in moderate-vigorous activity during and after the intervention. * Severity of anxiety and depressive symptoms. * Type and number of comorbid disorders. * On-going treatment in CAMHS, (i.e. medication and/or psychotherapy).

Short and long-term goals A. Perform the RCT, B. Analyse data, C. Publish results, D. Disseminate results via research network and regional collaboration to relevant groups and new patient populations, E. Build a strong research group on the topic and develop PhD project(s) based on the study.

3\. Methods 3.1. Study Design, Choice of Methodology and Analysis

The investigators will test the effectiveness of the CAHY intervention in a two-arm pragmatic randomized waitlist controlled trial (RCT) in which the participants will be randomly assigned to the intervention or the waitlist control group, following confirmation of eligibility and using a random number generator. Importantly, participants in the intervention and waitlist group have access to standard CAMHS care throughout the RCT, on the basis that this is their primary source of mental health care. It is not deemed ethical to withhold standard treatment for participants. Given that both intervention and waitlist groups continue with standard care, this will hinder any selection bias. Participants in the waitlist control group will be assigned to the intervention after the assessment at the post-intervention has been completed.

Study population and consent The target group are children and adolescents who receive healthcare treatment at a Child and adolescent specialized mental care clinic (CAMHS). Children and adolescents aged 8-17 are eligible.

Children and adolescents who should not do physical activity for health reasons are excluded.

Children and adolescents who do not wish or can not function in a group with other children and adolescents are excluded.

All participants in the study will be required to provide written consent. Informed written consent is obtained from all parents and assent is obtained from participants above age 12 years. Patients and parents can withdraw their consent at any time with no consequences for treatment in CAHY or CAMHS.

Measurements and outcomes

Primary outcomes:

\- Anxiety symptoms and depression symptoms. 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.

Secondary outcomes:

* Youth well-being. KID-SCREEN 27 is a generic questionnaire measuring health related quality of life and functional level. * Social participation in community (school and extracurricular), child-, parent versions. Study pecific questionnaire assessing social participation in and outside school attendance. * Daily physical activity level + session activity level: physical and sedentary activity (short and three-month follow-up). Objective measurement of activity using wearable activity sensor Actigraph GT3X+ monitor. * Daily physical activity and sleep habits, parent interview. The Simple Physical Activity Questionnaire (SIMPAQ).

Other variables:

* Demographic data: Assessed with parent self-response questionnaire. * Clinical characteristics: Participants give consent to access their CAMHS medical records.The investigators will retrieve following variables: a. CAMHS disorders, b. present medication, c. total time in CAMHS treatment before referral to CAHY, d. current CAMHS treatment offered (categorized).

Procedure Apart from participant's clinical characteristics, which will be manually collected from patient medical records following a codebook, assessments will be done digitally on a secure, research-approved platform, provided by Haukeland University Hospital. Participants are referred to the treatment by their attending therapist at one of the seven attending local outpatient Child and Adolescent Mental Health Clinic (CAMHS), Haukeland University Hospital. Referred and eligible participants are invited to a recruitment meeting where they receive detailed information about CAHY and the study and give consent/ascent to participate. Consenting participants fill out questionnaires at this time (T0). Enrolled participants are randomized to waitlist or active t

• Kidscreen-27 [Срок оценки: From enrollment to follow-up three months after end of treatment]
• Participation in community [Срок оценки: From enrollment to follow-up three months after end of treatment]
• Objective physical activity [Срок оценки: From enrollment to follow-up three months after end of treatment]
• Simple Physical Activity Questionnaire [Срок оценки: From enrollment to follow-up three months after end of treatment]