| - candidate number | 2285 |
| - NTR Number | NTR793 |
| - ISRCTN | ISRCTN24874457 |
| - Date ISRCTN created | 28-dec-2006 |
| - date ISRCTN requested | 18-dec-2006 |
| - Date Registered NTR | 16-okt-2006 |
| - Secondary IDs | 2007/047 MEC |
| - Public Title | On-line: Web-based Cognitive Behavioural Therapy (CBT) for Diabetic Adults with Minor to Moderately Severe Depression. A Randomised Controlled Trial. |
| - Scientific Title | On-line: Web-based Cognitive Behavioural Therapy (CBT) for Diabetic Adults with Minor to Moderately Severe Depression. A Randomised Controlled Trial. |
| - ACRONYM | ODDS (Online Depression in Diabetes Study) |
| - hypothesis | 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 (CAU, supplementend with information on depression) both at 3 and 6 month follow-up. |
| - Healt Condition(s) or Problem(s) studied | Depression, Diabetes Mellitus type 2 (DM type II), Diabetes Mellitus Type 1 (DM type I) |
| - Inclusion criteria | 1. 18 – 75 years of age; 2. Type 1 or type 2 diabetes (diagnosed by physician); 3. Minor to moderate depression (CES-D>16); 4. Easy acces to the Internet. |
| - Exclusion criteria | 1. Loss of significant other < previous 6 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 1-okt-2006 |
| - planned closingdate | 1-okt-2010 |
| - Target number of participants | 200 |
| - Interventions | A moderated web-based 12-weeks program to adults with minor to moderately severe depression. The program is based on the succesful program Coping with Depression (‘In de put, uit de put’), that will be tailored to the needs of persons living with diabetes. |
| - Primary outcome | Primary outcomes are depressive symptoms and diabetes-related distress. |
| - Secondary outcome | Secondary outcomes are satisfaction with the program, perceived health status, self-care, glycaemic control, days in bed/absence from work, and mental health care consumption. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | MA K.M.P. Bastelaar, van |
| - CONTACT for SCIENTIFIC QUERIES | MA K.M.P. Bastelaar, van |
| - Sponsor/Initiator | VU University Medical Center |
| - Funding (Source(s) of Monetary or Material Support) | Dutch Diabetes Research Foundation |
| - Publications | N/A |
| - Brief summary | Depression is common among people with diabetes, negatively affecting quality of life, treatment adherence and diabetes outcomes. For diabetes patients access to mental health services is limited and internet counseling is a potentailly effective way to provide psychosocial care to large groups of patients at low costs. In this study we aim to deliver a moderated web-based 12-weeks program to adults with minor to moderately severe depression, and test its efficacy and appreciation. The program is based on the succesful program Coping with Depression (‘In de put, uit de put’), that will be tailored to the needs of persons living with diabetes. The program is offered on an individual basis, with a weekly moderated group chat (forum). We propose a RCT in 180 patients (90/90), with measurements at baseline, 3 and 6 months after completion of the program. Primary outcomes are depressive symptoms and diabetes-related distress. Secondary outcomes are satisfaction with the program, perceived health status, self-care, glycaemic control, days in bed/absence from work, and mental health care consumption. Questionnaires are administered via the internet. Patients in the control condition receive care-as-usual, supplemented with minimal depression education. We hypothesize that 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, both at 3 and 6 month follow-up. |
| - Main changes (audit trail) | |
| - RECORD | 16-okt-2006 - 25-jan-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl