Welcome
Support Centre
21 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Online Depression in Diabetes Study: Web-based cognitive behavioural therapy for diabetic adults with depression
ISRCTN ISRCTN24874457
DOI 10.1186/ISRCTN24874457
ClinicalTrials.gov identifier
EudraCT number
Public title Online Depression in Diabetes Study: Web-based cognitive behavioural therapy for diabetic adults with depression
Scientific title On-line: web-based cognitive behavioural therapy for diabetic adults with co-morbid depression: a randomised controlled trial
Acronym ODDS
Serial number at source NTR793
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 (care as usual [CAU], supplemented with information on depression) both at three and six month follow-up.
Lay summary Not provided at time of registration
Ethics approval Added 06/02/2009: Ethical Review Committee of the VU University Medical Centre gave approval on the 6th June 2007
Study design Randomised, controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Minor to moderate depression
Participants - 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
Participants - 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
Anticipated start date 01/10/2006
Anticipated end date 01/10/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
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 successful program Coping with Depression (‘In de put, uit de put’), that will be tailored to the needs of persons living with diabetes.
Primary outcome measure(s) Primary outcomes are depressive symptoms and diabetes-related distress.
Secondary outcome measure(s) 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
Sources of funding Dutch Diabetes Research Foundation (Netherlands)
Trial website
Publications 1. 2008 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/18284670
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22262728
Contact name Dr  K M P  van Bastelaar
  Address VU University Medical Centre
Department of Medical Psychology
Diabetes Psychology Research Group
Van der Boechorststraat 7
MF A-312
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Tel +31 (0)20 444 8352
  Email k.vanbastelaar@vumc.nl
Sponsor Vrije University Medical Centre (VUMC) (Netherlands)
  Address Van der Boechorststraat 7
  City/town Amsterdam
  Zip/Postcode 1081 BT
  Country Netherlands
  Sponsor website: http://www.vumc.nl/
Date applied 28/12/2006
Last edited 24/01/2012
Date ISRCTN assigned 28/12/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.