Functional abdominal pain (FAP) within the context of internalizing disorders in childhood; A randomized controlled cognitive-behavioural family intervention.

Abdominal pain (AP) in children is ranked in the top five of visits to the
general practitioner and cross-sectional functional AP (FAP) is reported to
occur in 7-25% of the school age population. In these children significantly
higher scores for internalizing emotional symptoms (depression and anxiety) are
observed and studies suggest that *little bellyachers* grow up to suffer from
psychiatric ailments as adults.

We hypothesize that cognitive behavioural family intervention will be more
effective compared to standard treatment in regard to the perception of FAP and
resolution of co morbid internalizing psychopathology.

To study this we will enrol 100 patients (2x50/30 months) with moderate to
severe FAP, including children with co morbid anxiety and/or depression that
have significant non-attendance at school and examine the effect on the
severity of FAP and changes in disability, anxiety and depressive symptoms. The
duration of the study will be 48 months: 6 months preparation and pre-testing,
30 month enrolment followed by analysis and writing of papers

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 with the current practice of pediatricians in treating children with
FAP: supportive physician-patient relationship and empathy for the family with
reassurance that no serious disease is present. Dietray advice will be offered
(f.i. fiber intake). If necessary pharmacological agents can be prescribed
(laxative medication, spasmolytic drugs, H2 blockers or PP-inhibitors)

CBT:
Six treatment sessions with the patient and at least one with the parents that
will contain:
• information about the treatment model (influence of cognitions and behaviour
on the pain experience)
• learning pain management techniques (relaxation, breathing, imagery, physical
exercises)
• discussing dysfunctional cognitions (learning helping thoughts in stead of
catastrophizing thoughts)
• changing parent*s dysfunctional behaviour.
The content of the modules are described in detail in a protocol *CBT for FAP*.

Despite the fact that FAP shows a lot of resemblance to functional disorders in
adults, such as IBS and dyspepsia, FAP is a diagnosis specific for children. At
present no standard therapy is recommended for children with FAP. The current
practice of pediatricians in treating children with FAP varies but show some
aspects in common: supportive physician-patient relationship, empathy for the
family with reassurance that no serious disease is present, dietray advices,
and if necessary pharmacological agents such as laxative medication,
spasmolytic drugs, H2 blockers or PP-inhibitors.
A recent systematic review of RCT*s of FAP treatment modalities found only ten
articles that fulfilled preset criteria (Weydert 2003). Only CBT seemed to have
general positive effect on children with FAP independent of their Rome II
classification (Sanders 1989, Sanders 1994). However, in both (Australian)
studies a very limited number of patients was enrolled. Recently, a third
(American) RCT was published showing that CBT on top off standard medical
treatment (SMT) was more effective in the reduction of AP and school absence
compared to SMT only (Robins 2005). This study suffers a lot of methodological
limitations (inadequate randomization procedure, significant differences at
baseline, small sample size, loss of participants). Interestingly, a survey of
practicing pediatricians found that pediatricians rarely consulted mental
health professionals in the management of FAP (Edwards 1994). The primary
reasons cited for the lack of referrals were concerns about cost, family
resistance, and personal beliefs about the natural course of the disorder.
Another reason might be that the CBT studies were published in psychological
journals and likely were not read by practicing pediatricians as a means to
expand their repertoire of treatments for FAP. There is evidence in the adult
literature that management of functional disorders by the physician in
collaboration with a mental health professional may reduce health care costs
(Smith 1986).
Since three years a multidisciplinary Psy-Med Unit is functioning in our centre
incorporating mental health evaluations and treatment in the management of
children with severe FAP. The aim of our integrated approach is to facilitate
symptom resolution by integrating the coping and self-management skills with
other interventions, such as dietary and pharmaceutical (laxatives,
spasmolytics etc.) therapies within the context of the family. In a pilot
study children (7-18 yrs) with severe FAP (2nd or 3rd opinion, > 50% school
absenteeism, high level of self reported AP) showed dramatic improvement in
pain perception, school absenteeism and medical consumption following CBT. The
burden of CBT is minimal, in fact all children were happy with the CBT
treatment, and risks of CBT have not been described in the literature.
We hypothesize that cognitive behavioural family intervention is considered
especially promising in the reduction of AP, disability, resolution of co
morbid internalizing psychopathology and is economically feasible.