NCT05049759: CAH-Y

Physical Activity Intervention for Youth With Anxiety and Depression -Confident, Active and Happy Youth

Completed NA Last updated 12 March 2024

What this trial tests

NA trial testing Confident, Active and Happy Youth in Anxiety in 21 participants. Completed in 1 November 2022.

Timeline

1 July 2021

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 July 2021
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across Norway

Drugs / interventions tested

• Confident, Active and Happy Youth

Conditions studied

• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →
• Physical Activity — all drugs for Physical Activity →
• Activity Trackers — all drugs for Activity Trackers →

Sponsor

Haukeland University Hospital

Who can join

Adults 8 to 17, any sex, with Anxiety or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Feasibility of a physical activity intervention for children and adolescents with anxiety and depression.
   Kodal A, Muirhead F, Reilly JJ, Wergeland GJ, et al · · 2024 · cited 5× · PMID 38443992 · DOI 10.1186/s40814-024-01466-8
2. The effect of physical activity on anxiety symptoms among children and adolescents with mental health disorders: a research brief.
   Anker EA, Bøe Sture SE, Hystad SW, Kodal A. · · 2024 · cited 4× · PMID 38818022 · DOI 10.3389/fpsyt.2024.1254050
3. Development and feasibility testing of a physical activity intervention for youth with anxiety and depression: a study protocol.
   Kodal A, Muirhead F, Reilly JJ, Wergeland GJH, et al · · 2022 · cited 3× · PMID 35236419 · DOI 10.1186/s40814-022-01010-6
4. Feasibility of a physical activity intervention for children and adolescents with anxiety and depression
   Kodal A, Muirhead F, Reilly J, Wergeland G, et al · · 2024
5. Feasibility of a physical activity intervention for children and adolescents with anxiety and depression
   Kodal A, Muirhead F, Reilly JJ, Wergeland GJ, et al · · 2023 · DOI 10.21203/rs.3.rs-2873419/v1
6. Development and Feasibility Testing of a Physical Activity Intervention For Youth With Anxiety and Depression: a Study Protocol
   Kodal A, Reilly JJ, Muirhead F, Wergeland GJH, et al · · 2021 · DOI 10.21203/rs.3.rs-917447/v1