Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).

Study Overview
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Brief Summary
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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.

Detailed Description
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Objective: The primary objective is to determine the efficacy of a disease specific cognitive behavioral therapy program in adolescents with IBD and increased symptoms of depression or anxiety on reducing symptoms of depression. Secondary objectives are to assess the effect of the CBT program on a) the clinical course of disease b) reducing symptoms of anxiety, and c) improving quality of life. We also aim to identify psychosocial and medical factors that predict or moderate the treatment response to CBT in adolescent with IBD. Study design: The presented study is a multicenter randomized controlled trial (RCT), involving CBT versus care as usual (CAU), in young IBD patients with increased symptoms of self-reported depression or anxiety. There will be three follow-up moments, after 3 months or after the intervention and after 6 and 12 months. Study population: Patients with IBD between 10-25 years and increased symptoms of depression or anxiety. We aim to include 100 patients, from which 50 patients will be randomized to the treatment condition (CBT and CAU) and 50 to the control group (CAU). Intervention: A disease specific CBT program called PASCET-PI. The control group (CAU),will receive routine medical treatment (thus no additional psychosocial intervention) and will maintain their regular follow up visits at the gastroenterologist every 3 months. Main study endpoints: Main outcome is reduction in symptoms of depression. Important secondary outcomes are the presence of clinical relapse and reduction of symptoms of anxiety. Other secondary outcomes, amongst others, are IBD activity scores, quality of life, psychosocial functioning, and adherence to medical treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: At first, patients with IBD 10 -25 years of age will be screened for symptoms of depression and anxiety at T1. Patients with increased symptoms of self-reported depression or anxiety (scoring above an age and gender specific cut-off score for increased depressive or anxiety symptoms) are asked to participate in the RCT. For all included patients, 4 study visits will take place, these will be combined with regular checkup visits at the gastroenterologist. Questionnaires will need to be filled in online, taking approximately 1.5 hour per assessment for patients and approximately 1 hour per assessment for parents. At baseline a psychiatric assessment interview will be executed by an independent research clinical psychologist by phone (20 minutes). The same research clinical psychologist will conduct a short psychiatric assessment interview at the follow up visits 10minutes). At baseline and after 3 months blood samples (when patients undergo routine venous punctures) will be drawn. 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.

Official Title
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Reducing Symptoms of Depression and Anxiety in Adolescents With Inflammatory Bowel Disease in Order to Improve Quality of Life and the Clinical Course of Disease.

Conditions
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Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's Disease, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 10-25 years with diagnosed IBD Informed consent or assent by patients and (if necessary) parents Exclusion Criteria: IBD patients with parental report of mental retardation IBD patients receiving psychopharmacological treatment (antidepressants or benzodiazepines) for depression or anxiety No mastery of the Dutch language IBD patients with diagnosed: Bipolar disorder, Schizophrenia/psychotic disorder, Autism spectrum disorders, Obsessive-compulsive disorder, Posttraumatic stress disorder/Acute stress disorder, or Substance use disorder Physician reported substance abuse (alcohol, drugs) in the past month Clinician reported Selective mutism IBD patients already participating in an (psychological of psychopharmacological) intervention study IBD patients who received 8 sessions of manualized cognitive behavioral therapy last year current psychological treatment

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Care as usual<br>Care as usual means receiving their regular medical care. This consists of the regular follow up visits at the gastroenterologist every 3 months. | |
| Experimental: Cognitive Behavioral Therapy<br>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. | Behavioral: Cognitive behavioral therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioral therapy, Inflammatory bowel disease (IBD), Ulcerative colitis, Crohn's disease, Children, Adolescents, Anxiety, Depression