Condition category
Mental and Behavioural Disorders
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
01/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J Th M van Eijk

ORCID ID

Contact details

Universiteit Maastricht
Faculty of Health Sciences
Department of Health Care Studies
Section Medical Sociology
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882283
j.vaneijk@zw.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZONMW registration number: 945-03-047; NTR70

Study information

Scientific title

Acronym

DELTA (Depression in Elderly with Long-Term Afflictions)

Study hypothesis

Minimal psychological intervention (MPI) will reduce levels of depression and will increase their quality of life, while reducing health care-related costs in chronically ill elderly people with a depressed mood.

Ethics approval

Not provided at time of registration

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression

Intervention

Minimal psychological intervention (MPI) versus care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Beck Depression Inventory (BDI) assessed at baseline and at 3, 6 and 12 months after inclusion
2. Cost-effectiveness and cost-utility assessed using cost-diaries
3. EuroQol at baseline and at 3, 6, 9 and 12 months after inclusion

Secondary outcome measures

1. Quality of life (SF-36) assessed at baseline and at 3, 6 and 12 months after inclusion
2. Daily functioning
3. Self-efficacy
4. Autonomy
5. Participation

Overall trial start date

15/07/2003

Overall trial end date

15/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Established diagnosis of Diabetes Mellitus Type II or chronic obstructive pulmonary disease (COPD)
2. Age 60 years and over
3. Community dwelling
4. Minor depression or mild and moderate categories of major depression according to MINI and Hamilton-criteria (DSM-IV)
5. Completed informed consent.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

360

Participant exclusion criteria

1. Treatment with antidepressants
2. Major depression
3. Major psychiatric problems
4. Current psychosocial/psychiatric treatment
5. Serious cognitive problems (demential syndrome)
6. On waiting list for nursing home
7. Bedridden
8. Recent loss of spouse (<3 months)
9. Non Dutch-speaking

Recruitment start date

15/07/2003

Recruitment end date

15/11/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Universiteit Maastricht
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (The Netherlands)

Sponsor details

CAPHRI Research Institute
PO Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

http://www.caphri.nl/

Funders

Funder type

Government

Funder name

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

1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16790039
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19845979
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21368342
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21914242

Publication citations

  1. Protocol

    Lamers F, Jonkers CC, Bosma H, Diederiks JP, van Eijk JT, Effectiveness and cost-effectiveness of a minimal psychological intervention to reduce non-severe depression in chronically ill elderly patients: the design of a randomised controlled trial [ISRCTN92331982]., BMC Public Health, 2006, 6, 161, doi: 10.1186/1471-2458-6-161.

  2. Results

    Jonkers CC, Lamers F, Evers SM, Bosma H, Metsemakers JF, Van Eijk JT, Economic evaluation of a minimal psychological intervention in chronically ill elderly patients with minor or mild to moderate depression: a randomized trial (the DELTA-study)., Int J Technol Assess Health Care, 2009, 25, 4, 497-504, doi: 10.1017/S026646230999050X.

  3. Results

    Jonkers CC, Lamers F, Evers SM, Bosma H, Van Eijk JT, Cost-utility estimates in depression: does the valuation method matter?, J Ment Health Policy Econ, 2010, 13, 4, 189-197.

  4. Results

    Jonkers CC, Lamers F, Bosma H, Metsemakers JF, van Eijk JT, The effectiveness of a minimal psychological intervention on self-management beliefs and behaviors in depressed chronically ill elderly persons: a randomized trial., Int Psychogeriatr, 2012, 24, 2, 288-297, doi: 10.1017/S1041610211001748.

Additional files

Editorial Notes