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
Protocol serial number	N/A
Sponsor	Trimbos-institute - Netherlands Institute of Mental Health and Addiction (The Netherlands)
Funders	Reserve Voormalige Vrijwillige Ziekenfondsen (RVVZ) (The Netherlands) - a governmental non profit health organisation, The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Primary study design	Interventional
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
Secondary study design	Single-centre
Scientific title	Effectiveness of a breakthrough collaborative aimed at the implementation of depression guidelines in primary and secondary care
Study objectives	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(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) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	585
Total final enrolment	536
Key inclusion criteria	1. Aged 18 to 65 2. Sufficient Dutch language skills
Key exclusion criteria	1. Aged younger than 18 and older than 65 2. Insufficient Dutch langauage skills
Date of first enrolment	01/09/2006
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Trimbos Institute

Utrecht
3500 AS
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.