This study aims to test the effectiveness and appreciation of a web-based cognitive behavioural therapy (CBT) program for adult diabetic persons with minor to moderately severe depression in a randomized controlled trial.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
This study aims to test the effectiveness and appreciation of a web-based
cognitive behavioural therapy (CBT) program for adult diabetic persons with
minor to moderately severe depression in a randomized controlled trial.
Study design
We propose a RCT in 180 patients (90/90), with measurements at baseline, 3 and
6 months after completion of the program.
The experimental condition (on-line CBT) is compared to care-as-usual,
supplemented with a patient information booklet on depression.
Intervention
A moderated web-based 12-weeks program 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. The program is offered on an individual basis,
with a weekly moderated group chat (forum).
Study burden and risks
No risks are associated with participation and the burden is minimal.
Participants are asked to fill out a questionnaire via the Internet at three
moments in time and one short interview will take place over the telephone.
There are no risks or burden associated with participating in the
Internetprogramme.
Van der Boechorststraat 7
1081 BT Amsterdam
NL
Van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria: 18 * 75 years of age, type 1 or type 2 diabetes (diagnosed by physician), minor to moderate depression (CES-D>16), and easy access to the Internet.
Exclusion criteria
Exclusion criteria: loss of significant other < previous 6 months, history of suicide attempts, insufficient Dutch language skills, visually too impaired to read, major depressive disorder, currently taking anti-depressant medication, co-morbid organic psychiatric disorder, and alcohol or drug addiction.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN24874457 |
| CCMO | NL14981.029.07 |