Abstract and Introduction
Abstract
Objective: To evaluate the effectiveness of a disease-specific cognitive behavioral therapy (CBT) protocol on anxiety and depressive symptoms and health-related quality of life (HRQOL) in adolescents and young adults with inflammatory bowel disease (IBD).
Method: A parallel group randomized controlled trial was conducted in 6 centers of (pediatric) gastroenterology. Included were 70 patients and young adults (10–25 years) with IBD and subclinical anxiety and/or depressive symptoms. Patients were randomized into 2 groups, stratified by center: (a) standard medical care (care-as-usual [CAU]) plus disease-specific manualized CBT (Primary and Secondary Control Enhancement Training for Physical Illness; PASCET-PI), with 10 weekly sessions, 3 parent sessions, and 3 booster sessions (n = 37), or (b) CAU only (n = 33). Primary analysis concerned the reliable change in anxiety and depressive symptoms after 3 months (immediate posttreatment assessment). Exploratory analyses concerned (1) the course of anxiety and depressive symptoms and HRQOL in subgroups based on age, and (2) the influence of age, gender, and disease type on the effect of the PASCET-PI.
Results: Overall, all participants improved significantly in their anxiety and depressive symptoms and HRQOL, regardless of group, age, gender, and disease type. Primary chi-square tests and exploratory linear mixed models showed no difference in outcomes between the PASCET-PI (n = 35) and the CAU group (n = 33).
Conclusions: In youth with IBD and subclinical anxiety and/or depressive symptoms, preliminary results of immediate post-treatment assessment indicated that a disease-specific CBT added to standard medical care did not perform better than standard medical care in improving psychological symptoms or HRQOL. ClinicalTrials.gov: NCT02265588.
Introduction
Crohn's disease (CD) and ulcerative colitis (UC) are two types of inflammatory bowel disease (IBD). IBD is a chronic disease, that is characterized by episodes of exacerbation (with increased clinical symptoms) and clinical remission. Symptoms are abdominal pain, (bloody) diarrhea, fatigue, fever, and weight loss (Griffiths, 2004). In pediatric IBD (especially CD), malnutrition, resulting in delay of growth and puberty, is common (Sauer & Kugathasan, 2009). Adolescents and young adults (also referred to as youth) with IBD have a high risk for anxiety and/or depression (Mackner, Crandall, & Szigethy, 2006), possibly related to the unpredictable disease course and embarrassing symptoms (Greenley et al., 2010). Moreover, the inflammation-depression(-/anxiety) hypothesis is thought to explain the bidirectional association between inflammation in IBD and anxiety and/or depression. This hypothesis states that inflammation increases vulnerability for emotional symptoms and that treating these symptoms can decrease inflammation and thus improve the disease course (Bonaz & Bernstein, 2013).
In general, prevalence studies show elevated levels of anxiety and depressive symptoms in, respectively, 39%–50% (Kilroy, Nolan, & Sarma, 2011; Reigada et al., 2015) and 38%–55% (Clark et al., 2014; Szigethy et al., 2014) of adolescents with IBD. Only, a few studies report lower prevalence rates (Herzog et al. 2013). Furthermore, a meta-analysis showed higher rates of depressive and internalizing disorders in IBD youth, compared with other chronic conditions (Greenley et al., 2010).
At present, cognitive behavioral therapy (CBT) is the most effective evidence-based psychological treatment for anxiety and depression in youth (Compton et al., 2004). Until now, only a few studies evaluated CBT for youth with IBD. In a randomized controlled trial (RCT), Szigethy et al. (2007) found promising results of a disease-specific CBT in reducing depressive symptoms in 41 adolescents with IBD and subclinical depression. Furthermore, in a later study (N = 178), the same disease-specific CBT was effective in reducing depressive symptoms and improving health-related quality of life (HRQOL). However, supportive nondirective therapy had equally favorable outcomes (Szigethy et al., 2014). Reigada et al. (2013) found improvement in anxiety, pain, and disease activity in nine adolescents with anxiety disorders receiving CBT. In addition, a large recent trial in pediatric patients with IBD (N = 185), not selected on the presence of either somatic or psychological symptoms at baseline, examined the effect of a social learning and cognitive behavioral therapy (SLCBT) of only three sessions versus educational support. Although SLCBT outperformed educational support in improving IBD-related quality of life and school attendance, the authors found no difference between the two groups on anxiety and depression. The authors proposed low levels of disease activity and the short duration of the psychological treatment as possible explanations (Levy et al., 2016).
Taken together, CBT for youth with IBD seems beneficial. The mixed findings described earlier may be due to differences in the included patients, as some studies focused on either anxiety or depression separately (Reigada et al., 2013; Szigethy et al., 2014; Szigethy et al., 2007) or included all IBD patients rather than those selected on anxiety or depression (Levy et al., 2016). However, anxiety can precede depression, and anxiety and depression often occur together (Axelson & Birmaher, 2001; Garber & Weersing, 2010), so investigating both is important. Moreover, for CBT to be effective for anxiety/depression, patients have to experience at least elevated levels of anxiety and/or depressive symptoms, so selecting patients at baseline may be necessary (Mikocka-Walus, Andrews, & Bampton, 2016). Therefore, the present multicenter RCT aims to test the effectiveness of a disease-specific CBT on symptoms of both anxiety and depression as well as on HRQOL in adolescents and young adults with IBD (age = 10–25 years). This age range was chosen to cover the clinically relevant phases of adolescence and young adulthood, when IBD is often diagnosed (Sauer & Kugathasan, 2009) and can affect the many psychosocial changes that take place (e.g., becoming independent and identity formation).
The primary research question was as follows: Compared with standard medical care only, what is the effect of a disease-specific CBT added to standard medical care, on the level of anxiety and depressive symptoms, from pre- to post assessment, in adolescents and young adults with IBD aged 10–25 years?
Additional research questions were as follows: (1) What is the course of anxiety and depressive symptoms and HRQOL in subgroups based on age, regarding the effect of CBT? (2) What is the influence of age, gender, and disease type on the course of anxiety and depressive symptoms and HRQOL, regarding the effect of CBT? By these questions, we aim to examine which patients may benefit most from the disease-specific CBT. We hypothesized that patients in the disease-specific CBT group would improve more on anxiety and/or depressive symptoms and HRQOL compared with patients who received only standard medical care. In addition, we expected to find more effect of CBT in young adult patients (as they already face more life challenges, and could benefit more from the CBT skills than children), in women (as they often experience more anxiety and/or depressive symptoms than men), and in patients with CD (as the systemic symptoms in CD increase the burden of disease). We also investigated how patients (and parents) evaluate the disease-specific CBT (i.e., what is the social validity of the disease-specific CBT).
J Pediatr Psychol. 2018;43(9):967-980. © 2018 Oxford University Press
Copyright 2007 Society of Pediatric Psychology. Published by Oxford University Press. All rights reserved.
