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Cognitive Bias Modification: Exploring the effects of a computer-based cognitive bias training in patients with acute myeloid leukemia at risk for depression and anxiety symptoms -(HemaCogTrain)

Cognitive Bias Modification: Exploring the effects of a computer-based cognitive bias training in patients with acute myeloid leukemia at risk for depression and anxiety symptoms -(HemaCogTrain) - Cognitive bias modification in leukaemia patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46134
Enrollment
20
Registered
2017-09-26
Start date
2017-10-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukaemia blood cancer

Interventions

Patients will do 4 sessions of real or sham CBM ( half/half randomly assigned) within one week (7 days) time.
acute myeloid leukaemia
anxiety
depression
distress

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)