Online Depression in Diabetes Study: Web-based cognitive behavioural therapy for diabetic adults with depression
| ISRCTN | ISRCTN24874457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24874457 |
| Secondary identifying numbers | NTR793 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 24/01/2012
- 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
Dr K M P van Bastelaar
Scientific
Scientific
VU University Medical Centre
Department of Medical Psychology
Diabetes Psychology Research Group
Van der Boechorststraat 7
MF A-312
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8352 |
|---|---|
| k.vanbastelaar@vumc.nl |
Study information
| Study design | Randomised, controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | On-line: web-based cognitive behavioural therapy for diabetic adults with co-morbid depression: a randomised controlled trial |
| Study acronym | ODDS |
| Study objectives | The on-line intervention will prove to be significantly more effective in improving mood and reducing diabetes-related distress in diabetes patients with minor to moderately severe depression compared to the control condition (care as usual [CAU], supplemented with information on depression) both at three and six month follow-up. |
| Ethics approval(s) | Added 06/02/2009: Ethical Review Committee of the VU University Medical Centre gave approval on the 6th June 2007 |
| Health condition(s) or problem(s) studied | Minor to moderate depression |
| Intervention | A moderated web-based 12-weeks program to adults with minor to moderately severe depression. The program is based on the successful program Coping with Depression (In de put, uit de put), that will be tailored to the needs of persons living with diabetes. |
| Intervention type | Other |
| Primary outcome measure | Primary outcomes are depressive symptoms and diabetes-related distress. |
| Secondary outcome measures | 1. Satisfaction with the program 2. Perceived health status 3. Self-care 4. Glycaemic control 5. Days in bed/absence from work 6. Mental health care consumption |
| Overall study start date | 01/10/2006 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. 18 to 75 years of age, either sex 2. Type one or type two diabetes (diagnosed by physician) 3. Minor to moderate depression (Center for Epidemiological Studies Depression Scale [CES-D] more than 16) 4. Easy acces to the Internet |
| Key exclusion criteria | 1. Loss of significant other within the previous six months 2. History of suicide attempts 3. Insufficient Dutch language skills 4. Visually too impaired to read 5. Major depressive disorder 6. Currently taking anti-depressant medication 7. Co-morbid organic psychiatric disorder 8. Alcohol or drug addiction |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
Dutch Diabetes Research Foundation (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Diabetes Research Foundation
- Location
- Netherlands
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 | study protocol | 19/02/2008 | Yes | No | |
| Results article | results | 05/01/2012 | Yes | No |
