Plain English Summary

Not provided at time of registration

Trial website

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

http://www.trimbos.nl/default37.html

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

  1. 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.

  2. 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.

Editorial Notes