Condition category
Mental and Behavioural Disorders
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
24/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes