Contact information
Type
Scientific
Primary contact
Ms Martina Gross
ORCID ID
Contact details
Karl-Liebknecht-Str. 24-25
Potsdam
14476
Germany
+49 (0)331 977 2892
martina.gross@uni-potsdam.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of a cognitive behavioural treatment programme for children with chronic abdominal pain: a ranomised controlled trial
Acronym
STOPCAP
Study hypothesis
The main goal of the study is to investigate if the cognitive behavioural treatment ('Stop the Pain') is able to decrease the frequency and intensity of pain symptoms as well as to increase the quality of life as compared to 'wait-list-controls' (control group [CG]). The main hypothesis is that the treatment group (EG) will experience an improvement in pain-related coping skills and pain-related cognitions in comparison to the CG.
Publication on the pilot study (in German): Warschburger, P. & Gross, M. (2008). "Stopp den Schmerz" ein kognitiv-behaviorales Behandlungsprogramm für Kinder mit Bauchschmerzen. Erste Ergebnisse einer Pilotstudie. Verhaltenstherapie, 18, 162-167.
Ethics approval
Ethics Committee of the University of Potsdam, 11/06/2008
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic abdominal pain
Intervention
The developed and pilot-tested cognitive-behavioural treatment programme includes the following:
For children:
1. Guided relaxation
2. Information on CAP
3. Coping strategies
4. Altering negative cognitions
Children attend at least 6 weekly sessions (90 minutes each). The courses will be taught by psychologists.
For adults:
1. Information on the etiology and maintenance of CAP
2. How to support their child in pain-related coping
Adults attend one 2-hour training session. The course will be taught by psychologists and nutritionists.
The control group will receive only usual care during the interventions. They will have the opportunity to receive the same interventions once the trial has been completed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Abdominal pain (frequency and intensity). Intensity of pain is measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain).
2. Qualitty of life:
2.1. Quality of Life Inventory™ (PedsQL™)
2.2. Generic children's health-related quality of life (KINDL-R)
All primary and secondary outcomes will be measured at baseline, post-interventions and 3-month follow-up.
Secondary outcome measures
1. Coping with pain, assessed by PedsQL™ Pediatric Pain Coping Inventory (PedsQL™-PPCI)
2. Stress vulnerability (scale of SSKJ 3-8, Fragebogen zur Erhebung von Stress und Stressbewältigung im Kindes- und Jugendalter)
All primary and secondary outcomes will be measured at baseline, post-interventions and 3-month follow-up.
Overall trial start date
01/08/2008
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: 8-12 years, either sex
2. Informed consent (parent and children) to participate in the study
3. Children must have suffered from abdominal pain for at least three months
4. Pain occurs frequently (once a week), episodes of pain are severe enough to affect the child's activities
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
28
Participant exclusion criteria
1. Previous participation in a similar intervention for chronic abdominal pain (CAP)
2. CAP as a consequence of psychiatric disorders (e.g. depression, anxiety disorder)
Recruitment start date
01/08/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Karl-Liebknecht-Str. 24-25
Potsdam
14476
Germany
Sponsor information
Organisation
University of Potsdam (Germany)
Sponsor details
Potsdam Graduate School
Am Neuen Palais 10
Haus 2
Potsdam
14469
Germany
+49 331 977 1855
pogs@uni-potsdam.de
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Science, Research and Culture of the State of Brandenburg (Germany) - scholarship
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary