To evaluate the cost-effectiveness of a nurse-led stepped-care program for depression among primary care patients with type 2 diabetes mellitus and/or coronary heart disease and subtresshold depression in comparison with usual care.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The cumulative incidence of depression after 12 months according to an
independent Mini International Neuropsyciatric Interview (MINI)
Severity of depression symptoms
Quality of life
Secondary outcome
HbA1C
bloodpressure
LDL cholesterol
Background summary
Co-morbid depressive symptoms constitute a significant health problem among
patients with type 2 diabetes mellitus (DM2) and/or coronary heart disease
(CHD). Depressive symptoms increase the risk for major depression and are
associated with poor compliance to treatment, adverse health outcomes and lower
overall quality of life. Prevention of the development of major depression in
high risk patients is expected to reduce the burden of depression for
individuals and society.
Study objective
To evaluate the cost-effectiveness of a nurse-led stepped-care program for
depression among primary care patients with type 2 diabetes mellitus and/or
coronary heart disease and subtresshold depression in comparison with usual
care.
Study design
Economic evaluation alongside a cluster randomnized trial.
Intervention
The stepped-care program with a central role for patients consists of
sequentially watchful waiting, bibliotherapy, problem solving treatment (PST),
medication and referral to secondary care/psychiatrist if necessary.
Study burden and risks
Participating in this study will mean that patients have to fill in web-based
questionnaires at baseline and at 3, 6, 9 and 12 months. Patients in the
experimental condition will be offered a maximum of four sequential evidence
based treatment steps. Patients in the control condition will be offered care
as usual. No treatment will be denied to any participants nor will it be
postponed. There is no additional medical risk present for any participants in
this study. The experimental group will potentially have better treatment
options for their depressive symptoms.
de Boelelaan 1085
Amsterdam 1081 HV
NL
de Boelelaan 1085
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- 18 years and older
- diagnosis of diabetes mellitus type 2 and/or coronary heart disease
- in primary care
- subthreshold depression (scoring 6 points or more on PHQ-9 in combination with the absence of a diagnosis on the Mini International Neuropsychiatric Interviw (MINI)
Exclusion criteria
- bipolar disorder
- cognitive impairment or dementia
- psychotic illnes
- terminal illnes
- currently taking antidepressant medication
- a history of suicide attempts
- insufficient Dutch language skills
- visual impairments or illiteracy
- loss of significant other < previous six months
- pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39261.029.12 |