ISRCTN ISRCTN15266438
DOI https://doi.org/10.1186/ISRCTN15266438
Protocol serial number N/A
Sponsor Trimbos-institute/Netherlands Institute of Mental Health and Addiction (The Netherlands)
Funder Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (The Netherlands)
Submission date
01/12/2006
Registration date
01/12/2006
Last edited
27/08/2013
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 Marjoliek Ijff
Scientific

Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands

Phone +31 (0)30 2971185
Email mijff@trimbos.nl

Study information

Primary study designInterventional
Study designRandomised controlled parallel armed trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymCC:DIP
Study objectivesThe aim of the current Randomised Clinical Trial (RCT) is a cost-effectiveness analyses of a collaborative care approach compared to Care As Usual (CAU). The collaborative care approach is expected to be more effective and cost-effective than CAU.
Ethics approval(s)Study approved by the Medical Ethical Board of the Free University Medical Centre, Amsterdam, the Netherlands (reference number: protocol 06.158). Full approval of study design received on the 11th December 2006.
Health condition(s) or problem(s) studiedDepressive disorders
InterventionThe collaborative care approach includes care management, contracting, adherence improving strategies, manual guided self help and lifestyle interventions, Problem Solving Treatment (PST), and an antidepressant treatment algorithm; the treatment plan is set based on patient preferences.
Intervention typeOther
Primary outcome measure(s)

The primary outcome measure is response.

Key secondary outcome measure(s)

1. Remission as measured by the Patient Health Questionnaire (PHQ-9) and Inventory of Depressive Symptomatology (Self-Reported) (IDS-SR).
2. Effect of chronic physical illness as an effect modifier.
3. Cost-effectiveness as measured with the Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P), EuroQoL (EQ-5D) questionnaire and the Short Form health survey (SF-36).

Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target sample size at registration240
Key inclusion criteriaThe aim is to include patients who are diagnosed with major depressive disorder and who dysfunction due to the depressive disorder (i.e. loss of role in daily life).
Key exclusion criteria1. Suicidal, psychotic or suffering from dementia
2. Have insufficient knowledge of Dutch to fill in the questionnaires
3. Are addicted to drugs or alcohol
4. Already receive psychiatric treatment
5. Less than 18 years old
Date of first enrolment01/12/2006
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Utrecht
3500 AS
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 25/04/2013 Yes No
Other publications secondary data analysis 01/03/2013 Yes No