Condition category
Mental and Behavioural Disorders
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
24/04/2007
Prospective/Retrospective
Retrospectively 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

Ms G Franx

ORCID ID

Contact details

Trimbos Institute
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 295 9437
gfranx@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Implementation of innovations in mental health care needs multifaceted strategies in order to improve care with better outcomes for patients. The hypothesis in this study is: teams of health care professionals participating in a Breakthrough Depression Project implement national guidelines to a higher degree with better outcomes for patients than a control group of health care professionals and their patients receiving care as usual.

Ethics approval

Approval received from the local ethics board (METIGG-ZUID [South]) on the 18th April 2007 (ref: 6.115).

Study design

The design is a quasi-experimental trial, consisting of a systematic measurement of patient outcomes (depression symptoms and functional status) and care provided by practitioners (antidepressant prescription, monitoring) of the new Depression Collaborative

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Implementation, depression, guidelines

Intervention

The intervention group receives depression care according to guidelines, the control group receives care as usual.

Depression care according to guidelines concerns a series of effective interventions, in a specific order. According to this stepped care principle patients start at the lowest level of treatment from which an effect can be expected in order to step up to a more intense level of treatment, when the first step has not generated the expected effect within a number of weeks. The levels of treatment consist of one of more of the following interventions:
1. Information
2. Psycho-education
3. Individual or group self-help course
4. Running therapy
5. Problem solving treatment or brief psychotherapeutic interventions
6. Antidepressants
7. Psychotherapy (cognitive therapy, cognitive behavioural therapy, interpersonal psychotherapy)

Stepped care assumes that depression symptoms are being monitored. In the intervention group a Beck Depression Inventory will be administered every six weeks until the score is under ten.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Outcomes are on the professional, organisational and on the patient level.
1. The primary outcome measure of professional performance is:
a. a reduction of antidepressants prescription for patients with non-severe depression (reduction of overtreatment)
2. The primary outcome measure of organisational performance is:
a. a reduction of the waiting time to specialised depression treatment for patients with severe or long term depression (reduction of under-treatment)
3. The primary outcome measures on the patient level are:
a. a reduction in depressive symptoms and an improvement in disability status (effectiveness)

Secondary outcome measures

Secondary measures are:
1. Professional performance: satisfaction with collaboration, patient education delivered
2. Organisational level: monitoring system in use
3. Patient level outcomes: care consumption, satisfaction with care

Overall trial start date

01/09/2006

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 to 65
2. Sufficient Dutch language skills

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

585

Participant exclusion criteria

1. Aged younger than 18 and older than 65
2. Insufficient Dutch langauage skills

Recruitment start date

01/09/2006

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos Institute
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos-institute - Netherlands Institute of Mental Health and Addiction (The Netherlands)

Sponsor details

P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 297 1100
info@trimbos.nl

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

Reserve Voormalige Vrijwillige Ziekenfondsen (RVVZ) (The Netherlands) - a governmental non profit health organisation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Publication citations

Additional files

Editorial Notes