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 (youthCOACH CD) 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 postrandomization. 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.

Background Adolescents and young adults (AYA) with a chronic medical condition show an increased risk for developing mental comorbidities compared to their healthy peers. Internet- and mobile-based cognitive behavioral therapy (iCBT) might be a low-threshold treatment to support affected AYA. In this randomized controlled pilot trial, the feasibility and potential efficacy of youthCOACHCD, an iCBT targeting symptoms of anxiety and depression in AYA with chronic medical conditions, was evaluated. Methods A total of 30 AYA (Mage 16.13; SD= 2.34; 73% female), aged 12-21 years either suffering from cystic fibrosis, juvenile idiopathic arthritis or type 1 diabetes, were randomly assigned to either a guided version of the iCBT youthCOACHCD (IG, n=15) or to a waitlist control group (CG, n=15), receiving an unguided version of the iCBT six months post-randomization. Participants of the IG and the CG were assessed before (t0), twelve weeks after (t1) and six months after (t2) randomization. Primary outcome was the feasibility of the iCBT. Different parameters of feasibility e.g. acceptance, client satisfaction or potential side effects were evaluated. First indications of the possible efficacy with regard to the primary efficacy outcome, the Patient Health Questionnaire Anxiety and Depression Scale, and further outcome variables were evaluated using linear regression models, adjusting for baseline values. Results Regarding feasibility, intervention completion was 60%; intervention satisfaction (M = 25.42, SD = 5.85) and perceived therapeutic alliance (M = 2.83, SD = 1.25) were moderate and comparable to other iCBTs. No patterns emerged regarding subjective and objective negative side effects due to participation in youthCOACHCD. Estimates of potential efficacy showed between group differences, with a potential medium-term benefit of youthCOACHCD (β = -0.55, 95%CI: -1.17; 0.07), but probably not short-term (β = 0.20, 95%CI: -0.47; 0.88). Conclusions Our results point to the feasibility of youthCOACHCD and the implementation of a future definitive randomized controlled trial addressing its effectiveness and cost-effectiveness. Due to the small sample size, conclusions are premature, however, further strategies to foster treatment adherence should be considered. Trial registration The trial was registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (ID: DRKS00016714, 25/03/2019).

Objective A user-centered approach is critical for increasing the adherence to and effectiveness of an internet- and mobile-based intervention program. Therefore, potential future intervention users were involved in the development of an internet- and mobile-based cognitive behavioral therapy program (iCBT) for adolescents and young adults (AYA) with chronic medical conditions and comorbid symptoms of anxiety or depression. We aimed to identify challenges and coping strategies of the intended target group, as well as their needs and preferred intervention characteristics for an iCBT program. Methods Twenty AYA (aged 14–20, 60% females) with either type 1 diabetes (55%), juvenile idiopathic arthritis (25%) or cystic fibrosis (20%) were interviewed in condition-specific focus groups (4–11 participants per group) either via videoconferencing or face-to-face. Transcript verbatim data was analyzed using content analysis. Results Frequently reported disease-specific burdens were among others fear of disease progression, non-acceptance of disease and stressful incidents related to and aversions against medical therapy. Most frequently reported coping strategies included, seeking social support and accepting the disease. Recommendations for the content of an iCBT for comorbid symptoms of anxiety and depression comprised: dealing with disease-related fears and getting advice on health-promoting lifestyles. iCBT characteristics considered preferable by participants were: providing individual feedback by a real-person; implementation of a feature to monitor treatment progress; youthful and varied content presentation; time per session not exceeding 1 h; non-involvement of parents. A mobile-based reminder feature was considered useful, and individual tailoring and self-determination of iCBT content was considered desirable. Conclusions The findings highlight important patient perspectives and age-specific recommendations which can help design more optimal iCBT interventions for AYA with chronic medical conditions.

Mental comorbidities in patients with type 1 diabetes mellitus (T1D) are common, and can have a negative impact on acute blood glucose levels and long-term metabolic control. Information on the association of T1D and comorbid posttraumatic stress disorder (PTSD) with diabetes-related outcomes is limited. The aim was to examine the associations between a clinical diagnosis of PTSD and diabetes-related outcomes in patients with T1D. Patients with T1D and comorbid documented PTSD from the DPV database (n = 179) were compared to a group with T1D without PTSD (n = 895), and compared to a group with T1D without comorbid mental disorder (n = 895) by matching demographics (age, gender, duration of diabetes, therapy and migration background) 1:5. Clinical diabetes-related outcomes {body mass index (BMI), hemoglobin A1c (hbA1c), daily insulin dose, diabetic ketoacidosis (DKA), hypoglycemia, number of hospital admissions, number of hospital days} were analyzed, stratified by age groups (≤ 25 years vs. > 25 years). Patients with comorbid PTSD aged ≤ 25 years compared with patients without PTSD or patients without mental disorders had significantly higher HbA1c (8.71 vs. 8.30 or 8.24%), higher number of hospital admissions (0.94 vs. 0.44 or 0.32 per year) and higher rates of DKA (0.10 vs. 0.02 or 0.01 events/year). Patients with comorbid PTSD aged ≤ 25 years compared with patients without PTSD had significantly higher BMI (0.85 vs. 0.59) and longer hospital stays (15.89 vs.11.58 days) than patients without PTSD. Patients with PTSD > 25 years compared with patients without PTSD or without any mental comorbidities had significantly fewer hospital admissions (0.49 vs. 0.77 or 0.69), but a longer hospital length of stay (20.35 vs. 11.58 or 1.09 days). We found that PTSD in younger patients with T1D is significantly related to diabetes outcome. In adult patients with T1D, comorbid PTSD is associated with fewer, but longer hospitalizations. Awareness of PTSD in the care of patients with T1D should be raised and psychological intervention should be provided when necessary.

IntroductionComprehensive evidence on prevalence and incidence of post-traumatic stress disorder (PTSD) and symptoms (PTSS) in people with chronic somatic diseases (CD) is lacking.ObjectiveTo systematically and meta-analytically examine prevalence and incidence of PTSD and PTSS in people with CD compared with people without CD.MethodsMEDLINE, Embase, and PsycINFO were searched from inception (1946) to June 2020. Studies reporting point, 12-month, lifetime prevalence, or 12-month incidence of PTSD and PTSS in people with CD were selected and reviewed in accordance with PRISMA guidelines by two independent reviewers. Risk of bias was assessed by a combination of the Newcastle-Ottawa Scale and recommendations of the Cochrane Collaboration for non-comparative studies. Pooled estimates were calculated using random effects meta-analyses. Between-study heterogeneity was assessed using the I2 statistic.ResultsData were extracted from studies reporting on point prevalence (k = 60; n = 21,213), 12-month prevalence (k = 3; n = 913), and lifetime prevalence (k = 6; n = 826). 12-month incidence estimates were not available. The pooled estimate for the point prevalence of PTSD (k = 41) across CD was 12.7% (95% CI, 8.6 to 18.4%) and 19.6% regarding PTSS (13.2 to 28.1%; k = 24). Individuals with cerebrovascular disorder (k = 4) showed the highest pooled point prevalence for PTSD (23.6%, 95% CI, 16.8 to 32.0%), those with cardiovascular diseases the lowest (6.6%, 1.9 to 20.9%; k = 5). The pooled 12-month prevalence of PTSD (k = 3) was 8.8% (95% CI, 5.5 to 13.5%) and the lifetime prevalence (k = 6) was 12.1% (7.6 to 18.5%). Pooled estimates of PTSD prevalence in people with compared to those without CD showed an odds ratio of 9.96 (95% CI, 2.55 to 38.94; k = 5).ConclusionPost-traumatic stress disorder and PTSS are common and substantially higher in people with compared to those without CD. Earlier detection and treatment of this comorbidity might improve mental and physical health, reduce the incidence of further diseases, and reduce mortality.Clinical trial registrationhttps://osf.io/9xvgz, identifier 9xvgz.