Contact information
Type
Scientific
Primary contact
Ms Marjoliek Ijff
ORCID ID
Contact details
Trimbos-instituut/Netherlands institute of Mental Health and Addiction
Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 2971185
mijff@trimbos.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CC:DIP
Study hypothesis
The 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
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.
Study design
Randomised controlled parallel armed trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Depressive disorders
Intervention
The 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome measure is response.
Secondary outcome measures
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).
Overall trial start date
01/12/2006
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
The 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).
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
240
Participant exclusion criteria
1. 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
Recruitment start date
01/12/2006
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Trimbos-instituut/Netherlands institute of Mental Health and Addiction
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 2971100
info@trimbos.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Foundation Reserves Voormalige Vrijwillige Ziekenfondsverzekering (RVVZ) (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
2013 secondary data analysis in: http://www.ncbi.nlm.nih.gov/pubmed/23438706
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23068021
Publication citations
-
Secondary data analysis
Huijbregts KM, de Jong FJ, van Marwijk HW, Beekman AT, Adèr HJ, van der Feltz-Cornelis CM, A high physical symptom count reduces the effectiveness of treatment for depression, independently of chronic medical conditions., J Psychosom Res, 2013, 74, 3, 179-185, doi: 10.1016/j.jpsychores.2013.01.004.
-
Results
Huijbregts KM, de Jong FJ, van Marwijk HW, Beekman AT, Adèr HJ, Hakkaart-van Roijen L, Unützer J, van der Feltz-Cornelis CM, A target-driven collaborative care model for Major Depressive Disorder is effective in primary care in the Netherlands. A randomized clinical trial from the depression initiative., J Affect Disord, 2013, 146, 3, 328-337, doi: 10.1016/j.jad.2012.09.015.