Feasibility and potential efficacy of a guided internet- and mobile-based CBT for adolescents and young adults with chronic medical conditions and comorbid depression or anxiety symptoms (youthCOACHCD): a randomized controlled pilot trial

Abstract

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).

Internet-based and mobile-based cognitive behavioral therapy for chronic diseases: a systematic review and meta-analysis

“…Age range was compiled based on retrievable information from n = 24 (54.55%) studies (the remaining n = 20 studies did not provide such information). For “Intervention delivery format”, 1 article offered intervention through a mix of web-based (main) and mobile-app (complementary) platforms 40 . “Guidance” was defined as: “Guided” refers to therapists’ therapeutic input, including active provision of intervention, feedback, and/or support; “Unguided” refers to technical/adherence or other non-specified assistance only 12 .…”

“…Twelve studies were conducted in North America (US, Canada) 22 , 29 , 34 , 36 , 38 , 51 , 52 , 54 , 56 , 60 , 63 , 64 , 20 in Europe (Netherlands, Sweden, UK, Ireland, Germany, Norway) 21 , 24 – 27 , 31 , 35 , 37 , 39 , 40 , 43 – 45 , 47 , 53 , 55 , 58 , 59 , 61 , 62 , 10 in Australia 23 , 28 , 30 , 32 , 33 , 41 , 46 , 48 – 50 , and 2 in Asia (Japan, Korea) 42 , 57 . Three (6.82%), 24 (54.55%), and 17 (38.64%) studies were assessed to have low, some, and high risks of overall bias, respectively (Supplementary Table 6 ).…”

“…The effects on decreased PTSD symptoms 23 , 39 , 40 and combined depressive and anxiety symptoms 21 , 35 , 39 , 40 were significant at follow-up(s) only: at first follow-up (PTSD symptoms, g = 0.867, 95% CI [0.453, 1.282], p < 0.001; combined depressive and anxiety symptoms, g = 0.241, 95% CI [0.020, 0.461], p = 0.032), and last-follow-up (PTSD symptoms, g = 0.576, 95% CI [0.024, 1.128], p = 0.041).…”

“…IM-CBT related to decreased psychiatric symptoms among patients diagnosed with chronic pain ( g = 0.391, p < 0.001) 24 – 27 , 29 , 32 , 33 , 35 , 38 , 39 , 47 , 51 – 53 , 57 – 59 , 62 , 63 , cancer ( g = 0.495, p = 0.014) 21 , 23 , 28 , 36 , 42 , 43 , 48 , arthritis ( g = 0.402, p = 0.010) 37 , 45 , 50 , 54 , 56 , 60 , cardiovascular disease ( g = 0.504, p < 0.001) 41 , 44 , 55 , 61 , and different chronic diseases ( g = 0.566, p = 0.001) 34 , 40 , 46 , 64 , but not those with diabetes, multiple sclerosis, or HIV ( p s ≥ 0.154). Decreased symptoms were reported by patients who were not on concurrent psychotherapies for psychiatric condition(s) ( g = 0.396, p < 0.001) 21 – 29 , 31 – 47 , 50 – 64 but not those receiving psychotherapies ( p = 0.136).…”

“…IM-CBT effects were observed independent of patients’ gender and presence of comorbidity ( p s ≥ 0.287). Age as a potential moderator was not analyzed because most studies were conducted among people with a wide range of age (11–91 years, information retrievable from n = 24 studies) 23 , 27 , 29 , 31 – 35 , 37 – 40 , 42 , 44 – 47 , 50 – 53 , 57 , 58 , 62 while only mean age ( SD ) was available for all included studies.…”