Online Depression in Diabetes Study: Web-based cognitive behavioural therapy for diabetic adults with depression

ISRCTN	ISRCTN24874457
DOI	https://doi.org/10.1186/ISRCTN24874457
Protocol serial number	NTR793
Sponsor	Vrije University Medical Centre (VUMC) (Netherlands)
Funder	Dutch Diabetes Research Foundation (Netherlands)

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

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
Email	k.vanbastelaar@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, controlled, parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Primary outcomes are depressive symptoms and diabetes-related distress.
Key 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
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/01/2012		Yes	No
Protocol article	study protocol	19/02/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes