co morbide angst en depressie abdominal pain functional abdominal pain
Conditions
Interventions
Every patient, control and investigational treatment, receives standard medical
care (SMC). On top of SMC 50% of the patients are randomized to receive
cognitive behavorial therapy.
SMC:
In line
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: The enrolment criteria are in line with the Rome II criteria. • Abdominal pain that waxes and wanes • Occurs for three or more periodes over a 3-months period or longer • No red-flag signals • No abnormalities in the standard work-up • Severe enough to affect daily activities • Non-attendance at school 10% or more
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Organic cause abdominal pain • Major surgery • Previous major medical illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable is reduction in abdominal pain measured by the Abdominal Pain Index (API)*. Standard medical therapy (SMC) yields a mean outcome API score of around 20 (Robins et all., 2005). A clinically significant result of CBT is conceived as an extra improvement of 4 points or more in the API. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are anxiety and depression measured with The Anxiety Disorders Interview Schedule (ADIS-C/P; Silverman 1988, Siebelink 1995) and for symptoms using the Revised Child Anxiety and Depression Scale (RCADS; Chorpita 2000, Muris 2002). Other somatic symptoms measured by the Children*s Somatization Inventory (CSI; Walker 1992, Ghys 1993) | — |
Countries
Netherlands
Outcome results
None listed