Contact information
Type
Scientific
Primary contact
Dr K M P van Bastelaar
ORCID ID
Contact details
VU University Medical Centre
Department of Medical Psychology
Diabetes Psychology Research Group
Van der Boechorststraat 7
MF A-312
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8352
k.vanbastelaar@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR793
Study information
Scientific title
On-line: web-based cognitive behavioural therapy for diabetic adults with co-morbid depression: a randomised controlled trial
Acronym
ODDS
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/10/2006
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Dutch Diabetes Research Foundation (Netherlands)
Alternative name(s)
Dutch Diabetes Research Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
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. 2008 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/18284670
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22262728
Publication citations
-
Results
van Bastelaar KM, Pouwer F, Cuijpers P, Riper H, Twisk JW, Snoek FJ, Is a severe clinical profile an effect modifier in a Web-based depression treatment for adults with type 1 or type 2 diabetes? Secondary analyses from a randomized controlled trial., J. Med. Internet Res., 2012, 14, 1, e2, doi: 10.2196/jmir.1657.
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van Bastelaar KM, Pouwer F, Cuijpers P, Twisk JW, Snoek FJ, Web-based cognitive behavioural therapy (W-CBT) for diabetes patients with co-morbid depression: design of a randomised controlled trial., BMC Psychiatry, 2008, 8, 9, doi: 10.1186/1471-244X-8-9.