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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.

Nobis S, Lehr D, Ebert DD, Berking M, Heber E, Baumeister H, Becker A, Snoek F, Riper H - BMC Psychiatry (2013)

Bottom Line: 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 secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention.The data will be analysed on an intention-to-treat basis and per protocol.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Online Health Training, Innovation Incubator, Leuphana University Lüneburg, Lüneburg, Germany. nobis@inkubator.leuphana.de.

ABSTRACT

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.

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Related in: MedlinePlus

Study flow.
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Related In: Results  -  Collection

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Figure 1: Study flow.

Mentions: Measurement points are scheduled equally for both groups, at baseline and 8 weeks after randomisation. In addition, there will be follow-up measurements 6 and 12 months after randomisation (Figure 1).


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.

Nobis S, Lehr D, Ebert DD, Berking M, Heber E, Baumeister H, Becker A, Snoek F, Riper H - BMC Psychiatry (2013)

Study flow.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4225701&req=5

Figure 1: Study flow.
Mentions: Measurement points are scheduled equally for both groups, at baseline and 8 weeks after randomisation. In addition, there will be follow-up measurements 6 and 12 months after randomisation (Figure 1).

Bottom Line: 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 secondary outcome measures will be: diabetes-specific emotional distress, glycaemic control, self-management behaviour and the participants' satisfaction with the intervention.The data will be analysed on an intention-to-treat basis and per protocol.

View Article: PubMed Central - HTML - PubMed

Affiliation: Division of Online Health Training, Innovation Incubator, Leuphana University Lüneburg, Lüneburg, Germany. nobis@inkubator.leuphana.de.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus