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Physical Activity Intervention for Youth With Anxiety and Depression -Confident, Active and Happy Youth (CAH-Y)

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ClinicalTrials.gov Identifier: NCT05049759
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : September 20, 2021
Sponsor:
Collaborators:
University of Strathclyde
Western Norway University of Applied Sciences
University of Bergen
Information provided by (Responsible Party):
Haukeland University Hospital

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.


Condition or disease Intervention/treatment Phase
Anxiety Depression Physical Activity Activity Trackers Behavioral: Confident, Active and Happy Youth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility trial to establish acceptability and feasibility of the developed intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development, Testing and Implementation of a Physical Activity Intervention for Youth With Anxiety and Depression -Confident, Active and Happy Youth
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feasibility testing
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
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.
Other Name: CAH-Y




Primary Outcome Measures :
  1. Objective measure of activity change [ Time Frame: Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term) ]
    Actigraph measurement of youth activity level

  2. Anxiety symptom change [ Time Frame: Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term) ]
    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.

  3. Affective symptom change [ Time Frame: Pre-treatment, post-treatment (max. 2 weeks following end of treatment) and six months post treatment (long-term) ]
    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.

  4. Recruitment rate (number of youth referred/number of youth assessed as eligible). [ Time Frame: Pre-treatment ]
    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.

  5. Attendance rate (total number of sessions youth attend) [ Time Frame: From start of treatment to end of treatment (7 weeks) ]
    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. Attendence is presented as a percent.

  6. Retention rate (number of sessions youth completed before their last session) [ Time Frame: From start of treatment to end of treatment (7 weeks) ]
    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.


Secondary Outcome Measures :
  1. Key-process-related outcome e.g how did the participant experience the treatment. [ Time Frame: Through study completion, an average of 1 year ]
    Semi-structured qualitative interview



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05049759


Contacts
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Contact: Arne Kodal, PhD 94540624 ext 0047 arne.kodal@helse-bergen.no
Contact: Irene B Elgen, Dr.Med 91550904 ext 0047 irene.bircow.elgen@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Arne Kodal, PhD    94540624 ext 0047    arne.kodal@helse-bergen.no   
Contact: Irene B Elgen, Dr.Med    91550904 ext 0047    irene.bircow.elgen@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
University of Strathclyde
Western Norway University of Applied Sciences
University of Bergen
Investigators
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Principal Investigator: Arne Kodal, PhD Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT05049759    
Other Study ID Numbers: 30912
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are relevant for feasibility testing, thus not assessed relevant for IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Anxiety
Depression
Physical Activity
Youth
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders