The purpose of our exploratory study is to test the effect of a computer-based cognitive behavioural intervention (called Cognitive Bias Modification, CBM) on affective symptoms in patients with AML during their stay at the hospital.
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are change in affective (i.e., depression and anxiety)
and distress symptoms as measured by the HADS and the DASS 21. All primary
measures are sampled before and directly after as well as 1 week after the
intervention.
Secondary outcome
earlier life stress, psychological and cognitive aspects, and coping abilities
may modulate the vulnerability. Impact of these variables on the primary
outcome will be a secondary endpoint as well as individual clinical progression
of each individual patient after three- four weeks of treatment.
Background summary
Patients with a new diagnosis of acute myeloid leukemia (AML) are at risk of
experiencing a high symptom burden due to the disease and its treatment, which
includes a long period of hospitalization. While cognitive behavioral therapy
has been proven to be effective in reducing affective symptoms in cancer
patients, patients with AML are often too ill to undergo the full treatment
protocol which is highly dependent on verbal interaction. This imposes a
problem, especially because affective symptoms are frequent in this severely
diseased subgroup of somatic patients. We need a less burdensome and less
verbal treatment option for these patients.
Study objective
The purpose of our exploratory study is to test the effect of a computer-based
cognitive behavioural intervention (called Cognitive Bias Modification, CBM) on
affective symptoms in patients with AML during their stay at the hospital.
Study design
Half of the patients will receive treatment as usual (TAU) and perform 4
sessions of the active CBM training within one week (7 days) time. The other
half of the patients will receive a control CBM training concurrent to TAU.
Data on anxiety and depressive symptoms will be collected on these 20 patients
agreeing to participate in CBM. We will also use the clinical data of 10
patients treated during the same time for comparison against TAU. The brief
(app. 20 minute) CBM sessions of cognitive training will be done on a computer
brought to the patient*s ward. The sessions are planned so that they do not
interfere with medical treatment patients might receive.
Intervention
Patients will do 4 sessions of real or sham CBM ( half/half randomly assigned)
within one week (7 days) time.
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.
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Subjected to the ward of the department of hematology-oncology for treatment of a AML
- Hightened level of distress as measured with the *Distress Thermometer*. A *Distress Thermometer* score of 5 or higher was originally recommended as denoting significant distress necessitating psychosocial referral (National Comprehensive Cancer Network, 2005). 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 IRB-approved informed consent form
Exclusion criteria
- Impossibility to obtain a valid informed consent
- Severe depression or other psychiatric disorders that interfere with the ability to receive a cognitive intervention of 20 minutes per day
- Insufficient comprehension of the Dutch language
- IQ estimate < 80 points
- Acuteness of symptoms that prevent patient from attentively doing the task 20 min
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 |
|---|---|
| CCMO | NL61624.091.17 |