Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial.

INTRODUCTION: There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. OBJECTIVE: The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. METHODS: This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. RESULTS: Between October 2015 and July 2017, we randomly assigned 210 participants (IG, n = 105; CG, n = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (ß = -0.19, 95% CI -0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (p < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. CONCLUSION: The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

Effectiveness and cost-effectiveness of a guided internet- and mobile-based depression intervention for individuals with chronic back pain: protocol of a multi-centre randomised controlled trial.

INTRODUCTION: Depression often co-occurs with chronic back pain (CBP). Internet and mobile-based interventions (IMIs) might be a promising approach for effectively treating depression in this patient group. In the present study, we will evaluate the effectiveness and cost-effectiveness of a guided depression IMI for individuals with CBP (eSano BackCare-D) integrated into orthopaedic healthcare. METHODS AND ANALYSIS: In this multicentre randomised controlled trial of parallel design, the groups eSano BackCare-D versus treatment as usual will be compared. 210 participants with CBP and diagnosed depression will be recruited subsequent to orthopaedic rehabilitation care. Assessments will be conducted prior to randomisation and 9 weeks (post-treatment) and 6 months after randomisation. The primary outcome is depression severity (Hamilton Rating Scale for Depression-17). Secondary outcomes are depression remission and response, health-related quality of life, pain intensity, pain-related disability, self-efficacy and work capacity. Demographic and medical variables as well as internet affinity, intervention adherence, intervention satisfaction and negative effects will also be assessed. Data will be analysed on an intention-to-treat basis with additional per-protocol analyses. Moreover, a cost-effectiveness and cost-utility analysis will be conducted from a societal perspective after 6 months. ETHICS AND DISSEMINATION: All procedures are approved by the ethics committee of the Albert-Ludwigs-University of Freiburg and the data security committee of the German Pension Insurance (Deutsche Rentenversicherung). The results will be published in peer-reviewed journals and presented on international conferences. TRIAL REGISTRATION NUMBER: DRKS00009272; Pre-results.

Health related quality of life of a tertiary referral center population with urinary incontinence using the DCGM-10 questionnaire.

PURPOSE: We evaluated health related quality of life of pediatric patients with nonneurogenic urinary incontinence and determined potential influencing factors. Also, health related quality of life results in our sample were compared to those of other chronic childhood health conditions. MATERIALS AND METHODS: This cross-sectional study was done at 3 tertiary referral centers for childhood urinary incontinence. From July 2007 to April 2008 we consecutively evaluated 65 boys and 38 girls with a mean +/- SD age of 9.3 +/- 2.2 years (range 6 to 18) and their parents. Of the patients 12 had monosymptomatic enuresis, 79 had nonmonosymptomatic enuresis and 12 had isolated daytime incontinence. To evaluate participants we used the self-reported and proxy versions of the 10-item DISABKIDS chronic generic measure, short version, a health related quality of life questionnaire with cross-cultural validity. RESULTS: Mean questionnaire total scores were 43.2 and 42.8 for the self-reported and proxy versions, respectively, which showed significant correlation (r = 0.628). Age, sex, urinary incontinence type and severity, fecal incontinence and constipation had no significant association with questionnaire total scores (each p >0.05). Compared to questionnaire results in a reference sample of children with chronic health conditions average scores in our sample did not differ significantly from those in pediatric patients with asthma, arthritis, atopic dermatitis, cystic fibrosis, diabetes or epilepsy on the self-reported version, and asthma, atopic dermatitis, cystic fibrosis or epilepsy in the proxy version. CONCLUSIONS: Health related quality of life of children and adolescents with urinary incontinence appears to be comparable to that in pediatric patients with other chronic conditions, eg asthma or epilepsy.