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Randomized Controlled Trial
. 2017 Mar 4;18(1):100.
doi: 10.1186/s13063-017-1831-9.

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial

Bente Storm Mowatt Haugland  1 , Solfrid Raknes  2 , Aashild Tellefsen Haaland  3 , Gro Janne Wergeland  2   4 , Jon Fauskanger Bjaastad  2   5 , Valborg Baste  2 , Joe Himle  3   6 , Ron Rapee  7 , Asle Hoffart  8   9
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Randomized Controlled Trial

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial

Bente Storm Mowatt Haugland et al. Trials. .

Abstract

Background: Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention.

Methods/design: The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure.

Discussion: The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services.

Trial registration: ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

Keywords: adolescents; anxiety; low-intensity CBT; school-based.

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