Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Reinier de Graaf Groep | OTHER |
| Albert Schweitzer Hospital | OTHER |
| Maasstad Hospital | OTHER |
| Haga Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The presented study aims to reduce symptoms of depression and anxiety in adolescents with inflammatory bowel disease and increased symptoms of anxiety and depression by using the disease specific CBT program (PASCET-PI)in order to improve quality of life and to improve the clinical course of disease.
For patients in the CBT group, 13 sessions (6 outpatient sessions, 7 by phone) and three parental sessions will take place in a hospital close to their home. Our study population consists of adolescents and young adults with IBD, as this is a specific group with high reported symptoms of depression and anxiety, therefore they will most likely benefit from the intervention. The risks associated with participation can be considered negligible and the burden minimal. For the time investment of completing the questionnaires participants will receive an incentive of 25 euro after the final assessment, which will be communicated at the start.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care as usual | No Intervention | Care as usual means receiving their regular medical care. This consists of the regular follow up visits at the gastroenterologist every 3 months. | |
| Cognitive Behavioral Therapy | Experimental | The intervention group receives regular medical care (care as usual) AND a cognitive behavioral therapy program called PASCET-PI. The therapy sessions will be performed by trained psychologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy | Behavioral | A disease specific cognitive behavioral therapy program called PASCET-PI: The PASCET-PI model focuses on behavioral activation, cognitive restructuring and problem solving skills to change maladaptive behaviors, cognitions and coping strategies specific for IBD. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in symptoms of depression (change from baseline) | Measured by the Child Depression Inventory (CDI (10-17 years), Beck Depression Inventory (BDI; 18-25 years) and severity rating (interview): the Children's Depression Rating Scale (CDRS;10-12 years) and Adolescent Depression Rating Scale(ADRS;13-20 years), HAM-D: Hamilton Depression Rating Scale (21-25 year) | 12 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in symptoms of anxiety (change from baseline) | Measured by SCARED-NL: Screen for Anxiety Related Emotional Disorders (10-20 years), Hospital Anxiety and Depression Scale (HADS; 21-25 year) and severity rating by Pediatrix Anxiety Rating Scale (PARS) (10-20 years) ,Hamilton Anxiety Rating (HAM-A)(21-25 year) | 12 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease perception (change from baseline) | Assesses by the Brief Illness Perceptions Questionnaire (B-IPQ) | 12 weeks |
| Cognitive coping styles (change from baseline) | Assesses by the Cognitive Emotion Regulation Questionnaire (CERQ) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johanna C. Escher, PhD, MD | Erasmus Medical Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | Nederland | 3015CN | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17885570 | Background | Szigethy E, Kenney E, Carpenter J, Hardy DM, Fairclough D, Bousvaros A, Keljo D, Weisz J, Beardslee WR, Noll R, DeMASO DR. Cognitive-behavioral therapy for adolescents with inflammatory bowel disease and subsyndromal depression. J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1290-1298. doi: 10.1097/chi.0b013e3180f6341f. | |
| 22699797 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
| OTHER |
| Amphia Hospital | OTHER |
| Leiden University Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| General Quality of Life |
Assessed by the Child Health Related Quality of Life (TACQOL) (10-15 years) Adult Health Related Quality of Life (TAAQOL, 16-25 years) |
| 12 weeks and 52 weeks |
| Social Skills | Assessed by Social Skills Rating System (SSRS) (10-20years) Novotni SSC: Social Skills Checklist (21-25 year) | 12 weeks |
| Social competence | Assessed by Youth Self Report (YSR) / Adult Self Report (ASR) | 12 weeks |
| Disease specific quality of life | Assessed by the IMPACT-III-NL (10-20years) IBDQ: Inflammatory Bowel Disease Questionnaire (21-25 year) | 12 weeks and 52 weeks |
| Disease Activity | Assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) (10-20 years) Pediatric Crohn's Disease Activity Index (PCDAI) (10-20 years) CDAI: Crohn's Disease Activity Index (21-25 years) Partial Mayo Score (21-25 years) Physician Global Assessment (PGA) | 52 weeks |
| Clinical relapse (number of flares) | 10-20 Years: Relapse for CD is defined as PCDAI>30 or an increase of>15 points and intensification of medical treatment. Relapse for UC is defined as PUCAI > 34 or an increase of ≥20 points for UC and intensification of medical treatment. 21-25 years: Partial Mayo score of 3 or higher with intensification of medical treatment Or CDAI≥ 150 and an increase in baseline CDAI score of ≥ 70 points and intensification of medical treatment | 52 weeks |
| Maintaining remission | Remission is defined as PCDAI < 10 for CD and PUCAI < 10 for UC. CDAI < 150 and Mayo score ≤2 with no individual subscore > 1 | 52 weeks |
| Medication Usage (change from baseline) | Type and dosage of medication | 52 weeks |
| Necessity of surgical intervention | Description of type and extent of surgical intervention | 52 weeks |
| Adherence to therapy (change from baseline) | Assessed by the Morisky Medical Adherence Scale (MASS-8) | 52 weeks |
| Health care utilization (change from baseline) | Assessed by standardized items derived from the questionnaires and Report of the treating physician. | 52 weeks |
| Inflammatory markers | Inflammatory markers will be measured at all time points (baseline and after 3,6,12 months) Inflammatory markers like BSE, CRP, faecal calprotectin | baseline and 12, 24 and 52 weeks |
| 12 weeks |
| Quality of sleep (change from baseline) | Assesses by the Sleep Self-Report (SSR) (10-20 years) PSQI: Pittsburgh Sleep Quality Index (21-25 year) | 12 weeks |
| Demographic factors | Assesses by the Rotterdam's quality of life interview | 12 weeks |
| Parental anxiety and depression | Assesses by the Depression, Anxiety and Stress Scale (DASS-21) | 12 weeks |
| Life Events | Assesses by the Life events questionnaire from CERQ | 12 weeks |
| Family Functioning (change from baseline) | Assesses by the Family Assessment Device (FAD) | 12 weeks |
| Disease phenotypes | Assessed by the Paris Classification | 52 weeks |
| Treatment Strategy | The treatment strategy, type and dosage of medication will be extracted from the medical file and report of the treating physician. | 52 weeks |
| White blood cell RNA expression profiles (change from baseline) | Assessing immune status is done by analyzing gene expression profiles in peripheral blood leukocytes. This will be performed | 12 weeks |
| Immunological activity in peripheral blood mononuclear cells (PBMC) | A blood sample will be taken in all patients included within the Erasmus MC for determination of responsiveness of peripheral blood lymphocytes before and directly after the intervention | 12 weeks |
| Irritable bowel syndrome -like symptoms | Assessed by the ROME III diagnostic criteria for IBS in pediatric IBD patients | 12 months |
| Thompson RD, Craig A, Crawford EA, Fairclough D, Gonzalez-Heydrich J, Bousvaros A, Noll RB, DeMaso DR, Szigethy E. Longitudinal results of cognitive behavioral treatment for youths with inflammatory bowel disease and depressive symptoms. J Clin Psychol Med Settings. 2012 Sep;19(3):329-37. doi: 10.1007/s10880-012-9301-8. |
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
| 31506853 | Derived | Stapersma L, van den Brink G, van der Ende J, Szigethy EM, Groeneweg M, de Bruijne FH, Hillegers MHJ, Escher JC, Utens EMWJ. Psychological Outcomes of a Cognitive Behavioral Therapy for Youth with Inflammatory Bowel Disease: Results of the HAPPY-IBD Randomized Controlled Trial at 6- and 12-Month Follow-Up. J Clin Psychol Med Settings. 2020 Sep;27(3):490-506. doi: 10.1007/s10880-019-09649-9. |
| 29850915 | Derived | Stapersma L, van den Brink G, van der Ende J, Szigethy EM, Beukers R, Korpershoek TA, Theuns-Valks SDM, Hillegers MHJ, Escher JC, Utens EMWJ. Effectiveness of Disease-Specific Cognitive Behavioral Therapy on Anxiety, Depression, and Quality of Life in Youth With Inflammatory Bowel Disease: A Randomized Controlled Trial. J Pediatr Psychol. 2018 Oct 1;43(9):967-980. doi: 10.1093/jpepsy/jsy029. |
| 26966551 | Derived | van den Brink G, Stapersma L, El Marroun H, Henrichs J, Szigethy EM, Utens EM, Escher JC. Effectiveness of disease-specific cognitive-behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD). BMJ Open Gastroenterol. 2016 Mar 2;3(1):e000071. doi: 10.1136/bmjgast-2015-000071. eCollection 2016. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |