Physical Activity Based Treatment for Youth With Depression and Anxiety

NCT07304219 | Enrolling By Invitation

• 1 other identifier: 30912r
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Depression

Outcome Measures

Primary Outcomes (1)

• The Revised Child Anxiety and Depression Scale (RCADS)

  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.

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

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Behavioral: Confident, Active and Happy youth (CAHY)

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.

Interventions

Confident, Active and Happy youth (CAHY) BEHAVIORAL

CAHY is a group-based, bi-weekly, seven-week long, therapist led intervention targeting core symptoms of anxiety and depression (barriers). 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. 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. CAHY incorporates established knowledge from physiological and psychological theory to address these barriers. The interventions targets youth with mental health disorders, and is delivered in a clinical setting.

Treatment arm

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Western Norway University of Applied Sciences: collaborator
• University of Bergen: collaborator
• NORCE Norwegian Research Centre AS: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, Norway

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Arne Kodal, PhD

  NORCE - Norwegian Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: We 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. Participants in the waitlist control group will be assigned to the intervention after the assessment at post-waitlist has been completed. The waitlist condition is of equal time-length as the intervention.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

NO (1)