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: Design of a randomised controlled trial
Publikation: Beiträge in Zeitschriften › Zeitschriftenaufsätze › Forschung › begutachtet
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in: BMC Psychiatry, Jahrgang 13, 306, 15.11.2013.
Publikation: Beiträge in Zeitschriften › Zeitschriftenaufsätze › Forschung › begutachtet
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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 -