To study the effects and costs of a screening and treatment program for elderly with depressive symptoms in general practice.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference in severity of depressive symptoms as
measured with the Montgomery-Asberg Depression Rating Scale (MADRS) between 0
and 6 months in patients in the intervention arm versus usual care patients.
Secondary outcome
Secondary outcome measures (at 6 and 12 months) are differences in percentage
of responders, quality of life, use of (in)formal home care, medical
consumption, mortality and costs per quality adjusted life years (QALYs).
Background summary
Although depressive symptoms in the elderly have serious negative influences
and effective treatment is available, elderly with depressive symptoms are
often untreated. Under-recognition is an important reason; depressive symptoms
seem to be accepted as an unavoidable part of 'normal' aging. In general,
combined screening and treatment programs are advocated to treat depressive
symptoms more adequately. However, the effects and costs of such programs in
elder elderly in general practice are unknown.
Study objective
To study the effects and costs of a screening and treatment program for elderly
with depressive symptoms in general practice.
Study design
Pragmatic cluster randomised controlled trial with the general practice as the
unit of randomisation. Elderly aged 75 years and over enlisted in general
practices will be screened at baseline for depressive symptoms, measured by
Geriatric Depression Scale (GDS-15). If GDS-15 score is > 4 points intervention
or usual care will be offered according to the allocated treatment to their
general practice.
Intervention
In the intervention practices elderly with depressive symptoms will be offered
a stepped care treatment program, including 1) individual counselling by a
community psychiatric nurse 2) psycho-education by a Coping with Depression
group course or a similar therapy on individual basis, and 3) pharmacological
treatment and/or referral for patients with persistence of depressive symptoms
after step 1 and 2.
Study burden and risks
After agreement to participate in the study, the first part of baseline
measurement will take approximately 50 minutes, to administer the screening
questionnaires by a research nurse. In elderly who screen positive for
depression (GDS-15 > 4) and have no severe cognitive impairment an extension of
the baseline measurement is needed, mainly for measurement of severity of
depressive symptoms by the MADRS; this part will take approximately another 50
minutes. In those elderly who screen positive for depression and a sample of
elderly who screen negative for depression, outcome measurements will be
repeated at 6 months and 12 months.
Patients with severe depressive symptoms at baseline (MADRS >30 points) and/or
suicidal risk (according to the MADRS) will be referred to the GP, both in the
intervention and the control group, to discuss and provide appropriate
treatment.
Postbus 2088
2301CB Leiden
Nederland
Postbus 2088
2301CB Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria for screening: elderly aged 75 years and over enlisted in general practices. Inclusion criteria for treatment-offer: screen positive for depression (GDS-15 > 4).
Exclusion criteria
Exclusion criteria for screening: terminal illness (life expectancy < 3 months), current treatment for depression, loss of partner/important relative < 3 months ago and MMSE < 19 (confirmed in secondary care).
Exclusion criteria for treatment-offer: severe cognitive impairment (MMSE < 19).
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 |
---|---|
Other | kandidaatnummer NTR (Nederlands Trial Register): 2363 |
CCMO | NL15665.058.06 |