Depression in chronically ill elderly
| ISRCTN | ISRCTN92331982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92331982 |
| Secondary identifying numbers | ZONMW registration number: 945-03-047; NTR70 |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 01/05/2012
- 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
Prof J Th M van Eijk
Scientific
Scientific
Universiteit Maastricht
Faculty of Health Sciences
Department of Health Care Studies
Section Medical Sociology
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882283 |
|---|---|
| j.vaneijk@zw.unimaas.nl |
Study information
| Study design | Randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | DELTA (Depression in Elderly with Long-Term Afflictions) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Depression |
| Intervention | Minimal psychological intervention (MPI) versus care as usual. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 15/07/2003 |
| Completion date | 15/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 360 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/07/2003 |
| Date of final enrolment | 15/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Universiteit Maastricht
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
University Maastricht (The Netherlands)
University/education
University/education
CAPHRI Research Institute
PO Box 616
Maastricht
6200 MD
Netherlands
| Website | http://www.caphri.nl/ |
|---|---|
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Government
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/06/2006 | Yes | No | |
| Results article | results | 01/10/2009 | Yes | No | |
| Results article | results | 01/12/2010 | Yes | No | |
| Results article | results | 01/02/2012 | Yes | No |
