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. 2020 Mar 12;21(1):253.
doi: 10.1186/s13063-019-4041-9.

Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial

Frederike Lunkenheimer  1 , Matthias Domhardt  1 , Agnes Geirhos  1 , Reinhold Kilian  2 , Annabel S Mueller-Stierlin  2 , Reinhard W Holl  3 , Thomas Meissner  4 , Kirsten Minden  5   6 , Morten Moshagen  7 , Ramona Ranz  3 , Cedric Sachser  8 , Doris Staab  5 , Petra Warschburger  9 , Harald Baumeister  10 ; COACH consortium
Affiliations

Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial

Frederike Lunkenheimer et al. Trials. .

Abstract

Background: Adolescents and young adults (AYA) with chronic somatic conditions have an increased risk of comorbid depression and anxiety symptoms. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be one possibility to extend the access to evidence-based treatments. Studies suggest that guided iCBT can reduce anxiety and depression symptoms in AYA. However, little is known about the effectiveness of iCBT for AYA with chronic somatic conditions and comorbid symptoms of anxiety and/or depression in routine care. Evidence on the (cost-)effectiveness of iCBT is essential for its implementation in health care.

Objectives and methods: This multicentre two-armed randomized controlled trial (RCT) aims to evaluate the (cost-) effectiveness of guided iCBT (youthCOACHCD) in addition to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+) in AYA aged 12-21 years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety or depression (Patient Health Questionnaire [PHQ-9] and/or Generalized Anxiety Disorder [GAD-7] Screener score ≥ 7) will be eligible for inclusion. We will recruit 212 patients (2 × n = 106) in routine care through three German patient registries. Assessments will take place at baseline and at 6 weeks, 3 months, 6 months, and 12 months post-randomization. The primary outcome will be combined depression and anxiety symptom severity as measured with the PHQ Anxiety and Depression Scale. Secondary outcomes will include health-related quality of life, coping strategies, self-efficacy, stress-related personal growth, social support, behavioural activation, adjustment and trauma-related symptoms, automatic thoughts, intervention satisfaction, working alliance, and Internet usage. The cost-effectiveness will be determined, and potential moderators and mediators of intervention effects will be explored.

Discussion: iCBT might implicate novel ways to increase the access to evidence-based interventions in this specific population. The distinct focus on effectiveness and cost-effectiveness of youthCOACHCD in patients with chronic somatic conditions, as well as intervention safety, will most likely provide important new insights in the field of paediatric e-mental health. A particular strength of the present study is its implementation directly into routine collaborative health care. As such, this study will provide important insights for health care policy and stakeholders and indicate how iCBT can be integrated into existing health care systems.

Trial registration: German Clinical Trials Register (DRKS), DRKS00017161. Registered on 17 September 2019.

Keywords: AYA; Anxiety; Chronic somatic conditions; Depression; Internet- and mobile-based interventions; RCT.

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Conflict of interest statement

HB is a consultant for different insurance companies, health care associations, and psychotherapy chambers and gives talks and workshops and conducts a third party-funded project on iCBT and the dissemination and implementation of iCBT. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of inclusion and study procedure (youthCOACHCD = Internet- and mobile-based cognitive behavioural therapy)
See this image and copyright information in PMC

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