The purpose of our study is to test the effect of a computer-based cognitive behavioral intervention (called Cognitive Bias Modification, CBM) on affective symptoms in oncology patients. Here we are collaborating with the Oncology department of theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet-specifieke kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of our study is to measure changes in depressive and
anxiety symptoms from pre to post CBM training.
Secondary outcome
Our secondary aim is to explore patient*s psychological- and cognitive
processes, and course of oncology treatment as factors of our intervention.
Background summary
Patients undergoing treatment for cancer are at risk of experiencing a high
symptom burden that often leads to distress and affective symptoms. While
cognitive behavioral therapy has in principle been proven to be effective in
reducing affective symptoms in cancer patients, this option is not easily
available and sometimes too time- demanding for the patients that are focusing
on their somatic therapy. We need a less burdensome and less verbal treatment
option for these patients.Computer-based cognitive trainings have been proven
to be effective in affective disorders and there are promising results also in
breast cancer patients.
Study objective
The purpose of our study is to test the effect of a computer-based cognitive
behavioral intervention (called Cognitive Bias Modification, CBM) on affective
symptoms in oncology patients. Here we are collaborating with the Oncology
department of the VieCuri Hospital (Venlo).
Study design
Prospective, randomized, single centre study with an intervention and a control
treatment arm. Both treatments are provided besides treatment as usual (TAU)
and do not intervene with TAU.
Intervention
Randomly assigned, half of the patients will receive treatment as usual (TAU)
and perform a weekly session of the active CBM training for 4 weeks. The other
half of the patients will receive a control CBM training concurrent to TAU. The
brief (app. 20 minute) CBM sessions of cognitive training will be done on a
computer. The sessions are planned so that they do not interfere with medical
treatment patients might receive.
Study burden and risks
The routine clinical practice at the day of the intervention will be extended
by a cognitive training that comes with neglectable risks. There is also no
increased risk associated to administering a short battery of questionnaires or
the intervention itself. These assessments are unobtrusive.
Renier Postlaan 10
Nijmegen 6525HB
NL
Renier Postlaan 10
Nijmegen 6525HB
NL
Listed location countries
Age
Inclusion criteria
- Receiving current cancer treatment
- Patients with a score of 8 or higher in the HADS will be considered for participation in the study (HADS; Zigmond & Snaith, 1983). This cut-off shows good sensitivity and specificity in a somatic patient population (Bjelland et al., 2002).
- Signed informed consent form
Exclusion criteria
- Impossibility to obtain a valid informed consent
- Insufficient comprehension of the Dutch language
- IQ estimate < 80 points
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL68493.091.18 |
OMON | NL-OMON29198 |