Condition category
Digestive System
Date applied
15/09/2009
Date assigned
03/11/2009
Last edited
16/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uni-potsdam.de/

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

Publication citations

Additional files

Editorial Notes