TY - JOUR

T1 - Efficacy and cost-effectiveness of a web-based intervention with mobile phone support to treat depressive symptoms in adults with diabetes mellitus type 1 and type 2

T2 - Design of a randomised controlled trial

AU - Nobis, Stephanie

AU - Lehr, Dirk

AU - Ebert, David Daniel

AU - Berking, Matthias

AU - Heber, Elena

AU - Baumeister, Harald

AU - Becker, Annette

AU - Snoek, Frank

AU - Riper, Heleen

N1 - Funding Information: We would like to acknowledge the European Union for funding this project (EFRE: CCI 2007DE161PR001) and the BARMER GEK for supporting the recruitment of this study.

PY - 2013/11/15

Y1 - 2013/11/15

N2 - Background: A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms.Methods/Design: A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective.Discussion: If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes.Trial registration: German Clinical Trial Register (DRKS): DRKS00004748.

AB - Background: A diagnosis of diabetes mellitus types 1 or 2 doubles the odds of a comorbid depressive disorder. The combined diseases have a wide range of adverse outcomes, such as a lower quality of life, poorer diabetes outcomes and increased healthcare utilisation. Diabetes patients with depression can be treated effectively with psychotherapy, but access to psychological care is limited. In this study we will examine the efficacy and cost-effectiveness of a newly developed web-based intervention (GET.ON Mood Enhancer Diabetes) for people with diabetes and comorbid depressive symptoms.Methods/Design: A two-arm randomised controlled trial will be conducted. Adults with diabetes (type 1 or type 2) with increased depression scores (> 22 on the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) will be included. Eligible participants will be recruited through advertisement in diabetes patient journals and via a large-scale German health insurance company. The participants will be randomly assigned to either a 6-week minimally guided web-based self-help program or an online psychoeducation program on depression. The study will include 260 participants, which will enable us to detect a statistically significant difference with a group effect size of d = 0.35 at a power of 80% and a significance level of p = 0.05. The primary outcome measure will be the level of depression as assessed by the CES-D. The secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention. Online self-assessments will be collected at baseline and after a 2 months period, with additional follow-up measurements 6 and 12 months after randomisation. The data will be analysed on an intention-to-treat basis and per protocol. In addition, we will conduct an economic evaluation from a societal perspective.Discussion: If this intervention is shown to be cost-effective, it has considerable potential for implementing psychological care for large numbers of people with diabetes and comorbid depression in routine practice and improve health outcomes.Trial registration: German Clinical Trial Register (DRKS): DRKS00004748.

KW - Health sciences

KW - Diabetes mellitus

KW - Cost-effectiveness

KW - Depression

KW - Diabetes

KW - Efficacy

KW - Guided web-based self-help

KW - Internet

KW - Randomised controlled trial

KW - Psychology

KW - depressive Symptome

KW - internetbasierte Therapie

KW - web-basierte Intervention

UR - http://www.scopus.com/inward/record.url?scp=84887544960&partnerID=8YFLogxK

UR - https://www.mendeley.com/catalogue/2652a7de-63a0-3524-9011-f9aa8b6caad5/

U2 - 10.1186/1471-244X-13-306

DO - 10.1186/1471-244X-13-306

M3 - Journal articles

C2 - 24238346

VL - 13

JO - BMC Psychiatry

JF - BMC Psychiatry

SN - 1471-244X

M1 - 306

ER -