Condition category
Mental and Behavioural Disorders
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
22/03/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr G M van der Weele

ORCID ID

Contact details

Leiden University Medical Center (LUMC)
Department of Public Health and Primary Care
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 8444
G.M.van_der_Weele@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PROMODE

Study hypothesis

A screening and stepped care treatment program for elderly with depressive symptoms in general practice will lead to significant reduction of depressive symptoms and costs in comparison to Care As Usual (CAU).

Ethics approval

Approval received from the Medical Ethics Committee of the Leiden University Medical Centre (Commissie medische ethiek van het Leids Universitair Medisch Centrum [LUMC]) on the 27th February 2007. We also received a letter of approval from the Raad van Bestuur (Board of Directors) of the LUMC.

Study design

Pragmatic cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

Depressive symptoms

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.

In the control practices elderly will receive care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Difference in severity of depressive symptoms (Montgomery Asberg Depression Rating Scale [MADRS] baseline - six months).

Secondary outcome measures

Differences (at six and 12 months) in:
1. Percentage responders to treatment
2. Quality of life (Short Form health survey [SF-36], EuroQol questionnaire [EQ-5D])
3. Mortality
4. Use of (in)formal help or home care
5. Medical consumption
6. Cost-effectiveness
7. Costs per Quality Adjusted Life Year (QALY)

Overall trial start date

01/03/2007

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Inclusion criteria for screening: elderly aged 75 years and over enlisted in general practices
2. Inclusion criteria for treatment-offer: screen positive for depression (Geriatric Depression Scale [GDS-15] more than four)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

4000

Participant exclusion criteria

1. Exclusion criteria for screening: terminal illness, current treatment for depression, loss of partner/important relative within previous three months
2. Exclusion criteria for treatment-offer: severe cognitive impairment (Mini Mental State Examination [MMSE] less than 19)

Recruitment start date

01/03/2007

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (Netherlands)

Sponsor details

Department of Public Health and Primary Care
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20665554
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22427507

Publication citations

  1. Results

    van der Weele GM, de Waal MW, van den Hout WB, van der Mast RC, de Craen AJ, Assendelft WJ, Gussekloo J, Yield and costs of direct and stepped screening for depressive symptoms in subjects aged 75 years and over in general practice., Int J Geriatr Psychiatry, 2011, 26, 3, 229-238, doi: 10.1002/gps.2518.

  2. Results

    van der Weele GM, de Waal MW, van den Hout WB, de Craen AJ, Spinhoven P, Stijnen T, Assendelft WJ, van der Mast RC, Gussekloo J, Effects of a stepped-care intervention programme among older subjects who screened positive for depressive symptoms in general practice: the PROMODE randomised controlled trial., Age Ageing, 2012, 41, 4, 482-488, doi: 10.1093/ageing/afs027.

Additional files

Editorial Notes