An interventional study of Internet-delivered Cognitive behavior therapy in Functional Abdominal Pain Disorders, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.
338 studies on the registry are indexed under Abdominal Pain; 55 are open to participants now.
This study's enrollment of 91 is above the median of 72 across 250 interventional studies indexed under Abdominal Pain.
Browse Abdominal Pain studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform.
Behavioral: Internet-delivered Cognitive behavior therapy
This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments.
The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale
Change in pain intensity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9).
Faces Pain Rating Scale rated by parents
Change in child's pain intensity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Faces Pain Rating Scale rated by parents
Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9).
PedsQL Gastro rated by parents
Change in child gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
PedsQL Gastro rated by parents
Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.
Time frame: Weekly during treatment (treatment week 1-9).
Pediatric quality of life inventory (PedsQL QOL)
Change in quality of life measured measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pediatric quality of life inventory (PedsQL QOL) rated by parents
Change in child quality of life measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Change in pain free days measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days
Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
Painfree days rated by parents
Change in child's pain free days measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Painfree days rated by parents
Change in child's pain free days measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ)
Change in childs behavioral responses to abdominal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
IBS-Behavioral responses questionnaire (IBS-BRQ)
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
Spence Children Anxiety Scale - short version (SCAS-S)
Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Spence Children Anxiety Scale - short version (SCAS-S) rated by parents
Change in child's anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Child Depression Inventory - short version (CDI-S)
Change in child's depressive symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Change in visceral sensitivity measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Visceral Sensitivity Index
Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
Client Satisfactory Questionnaire (CSQ)
Client satisfaction rated measured with a self-rating scale
Time frame: At week 10
Client Satisfactory Questionnaire (CSQ) rated by parents
Client satisfaction rated measured with a self-rating scale
Time frame: At week 10
Subjective Assessment Questionnaire (SAQ)
Subjective change in symptoms measured with a self-rating scale
Time frame: At week 10
Subjective Assessment Questionnaire (SAQ) rated by parents
Subjective change in the child's symptoms measured with a self-rating scale by the parents.
Time frame: At week 10
Rome-IV questionnaire
Change in diagnostic status of functional abdominal pain disorder measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Kidscreen
Change in quality of life for use in economic evaluation measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Change in child's school absenteeism measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
School absenteeism rated by parents
Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
Pain Catastrophizing Scale, parental version (PCS-P)
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Pain Catastrophizing Scale, parental version (PCS-P)
Change in parental catastrophizing of the child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
Children´s Somatization Inventory (CSI 24) rated by parents
Change in child's somatization symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adverse events (AE)
Adverse events during treatment measured with a self-rating scale by the parents.
Time frame: At week 10
Working Alliance Inventory (WAI) short version
Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.
Time frame: At week 4
The treatment credibility scale rated by parents.
Treatment credibility measured with a self-rating scale by the parents.
Time frame: At week 2
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents
Costs associated with the disorder measured with a self-rating scale by the parents.
Time frame: Baseline, at weeks 3, 7, 10 and at 9 months
General health questionnaire (GHQ-12) rated by parents
Change in general health measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Generalised anxiety disorder assessment (GAD 7) rated by parents
Change in parental anxiety symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Change in parental responses to child's symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.
Time frame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Adult responses to children's symptoms (ARCS) rated by parents
Change in parental responses to child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9)
PedsQL Gastro
Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.
Time frame: Weekly during treatment (treatment week 1-9).
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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