Effectiveness of a breakthrough collaborative aimed at the implementation of depression guidelines in primary and secondary care

ISRCTN ISRCTN99634826
DOI https://doi.org/10.1186/ISRCTN99634826
Secondary identifying numbers N/A
Submission date
26/02/2007
Registration date
26/02/2007
Last edited
09/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms G Franx
Scientific

Trimbos Institute
P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone +31 (0)30 295 9437
Email gfranx@trimbos.nl

Study information

Study designThe 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 designInterventional
Secondary study designSingle-centre
Study setting(s)Not specified
Study typeNot Specified
Scientific titleEffectiveness of a breakthrough collaborative aimed at the implementation of depression guidelines in primary and secondary care
Study objectivesImplementation 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(s)Approval received from the local ethics board (METIGG-ZUID [South]) on the 18th April 2007 (ref: 6.115).
Health condition(s) or problem(s) studiedImplementation, depression, guidelines
InterventionThe 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 typeOther
Primary outcome measureOutcomes 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 measuresSecondary 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 study start date01/09/2006
Completion date01/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants585
Total final enrolment536
Key inclusion criteria1. Aged 18 to 65
2. Sufficient Dutch language skills
Key exclusion criteria1. Aged younger than 18 and older than 65
2. Insufficient Dutch langauage skills
Date of first enrolment01/09/2006
Date of final enrolment01/03/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Trimbos Institute
Utrecht
3500 AS
Netherlands

Sponsor information

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

P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone +31 (0)30 297 1100
Email info@trimbos.nl
ROR logo "ROR" https://ror.org/02amggm23

Funders

Funder type

Government

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/06/2009 09/05/2019 Yes No

Editorial Notes

09/05/2019: Publication reference and total final enrolment added.