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

NCT05049759 | Completed

• 1 other identifier: 30912
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression; Physical Activity; Activity Trackers

Keywords

Anxiety; Depression; Physical Activity; Youth

Outcome Measures

Primary Outcomes (6)

• Objective measure of activity change

  Actigraph measurement of youth activity level

  Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term)

• Anxiety symptom change

  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.

  Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term)

• Affective symptom change

  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.

  Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term)

• Recruitment rate (number of youth referred/number of youth assessed as eligible).

  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.

  Pre-treatment

• Attendance rate (total number of sessions youth attend)

  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.

  From start of treatment to end of treatment (7 weeks)

• Retention rate (number of sessions youth completed before their last session)

  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.

  From start of treatment to end of treatment (7 weeks)

Secondary Outcomes (1)

• Key-process-related outcome e.g how did the participant experience the treatment.

  Through study completion, an average of 1 year

Study Arms (1)

Feasibility testing

EXPERIMENTAL

The feasibility trial, aims to assess the feasibility of the intervention, including assessment of acceptability and outcome measures. 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.

Behavioral: Confident, Active and Happy Youth

Interventions

Confident, Active and Happy Youth BEHAVIORAL

The three target goals of the intervention (confident, active and happy) link closely to the core symptoms of internalizing disorders. Thus, a core symptom of anxiety is a lack of confidence in one's ability to cope with a given fearful situation. The ensuing behavioral reaction is avoidance of the situation and/or enduring it with excessive discomfort. Similarly, a core symptom of a depressive disorder is lowered mood. Regarding both depression and anxiety, both disorders are associated with less physical activity, and low levels of physical activity conversely help maintain the disorders. As such, the aim is to alleviate symptoms and supplement ongoing treatment in CAMHS.

Also known as: CAH-Y

Feasibility testing

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Strathclyde: collaborator
• Western Norway University of Applied Sciences: collaborator
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (3)

• Anker EA, Boe Sture SE, Hystad SW, Kodal A. The effect of physical activity on anxiety symptoms among children and adolescents with mental health disorders: a research brief. Front Psychiatry. 2024 May 13;15:1254050. doi: 10.3389/fpsyt.2024.1254050. eCollection 2024.

  PMID: 38818022 DERIVED

• Kodal A, Muirhead F, Reilly JJ, Wergeland GJ, Thorsen PJB, Bovim LP, Elgen IB. Feasibility of a physical activity intervention for children and adolescents with anxiety and depression. Pilot Feasibility Stud. 2024 Mar 5;10(1):49. doi: 10.1186/s40814-024-01466-8.

  PMID: 38443992 DERIVED

• Kodal A, Muirhead F, Reilly JJ, Wergeland GJH, Thorsen PJB, Bovim LP, Elgen IB. Development and feasibility testing of a physical activity intervention for youth with anxiety and depression: a study protocol. Pilot Feasibility Stud. 2022 Mar 2;8(1):48. doi: 10.1186/s40814-022-01010-6.

  PMID: 35236419 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Arne Kodal, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility trial to establish acceptability and feasibility of the developed intervention.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 20, 2021
• Study Start: July 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)