Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). (HAPPY-IBD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02265588|
Recruitment Status : Unknown
Verified March 2017 by J.C. Escher, M.D., Ph.D, Erasmus Medical Center.
Recruitment status was: Active, not recruiting
First Posted : October 16, 2014
Last Update Posted : March 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease (IBD) Ulcerative Colitis Crohn's Disease Anxiety Depression||Behavioral: Cognitive behavioral therapy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 1, 2016|
|Estimated Study Completion Date :||September 2017|
No Intervention: Care as usual
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
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
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.
- Reduction in symptoms of depression (change from baseline) [ Time Frame: 12 weeks and 52 weeks ]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)
- Reduction in symptoms of anxiety (change from baseline) [ Time Frame: 12 weeks and 52 weeks ]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)
- Quality of Life [ Time Frame: 12 weeks and 52 weeks ]Assessed by the Child Health Related Quality of Life (TACQOL) (10-15 years) Adult Health Related Quality of Life (TAAQOL, 16-25 years)
- Social Skills [ Time Frame: 12 weeks ]Assessed by Social Skills Rating System (SSRS) (10-20years) Novotni SSC: Social Skills Checklist (21-25 year)
- Social competence [ Time Frame: 12 weeks ]Assessed by Youth Self Report (YSR) / Adult Self Report (ASR)
- Disease specific quality of life [ Time Frame: 12 weeks and 52 weeks ]Assessed by the IMPACT-III-NL (10-20years) IBDQ: Inflammatory Bowel Disease Questionnaire (21-25 year)
- Disease Activity [ Time Frame: 52 weeks ]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)
- Clinical relapse (number of flares) [ Time Frame: 52 weeks ]
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
- Maintaining remission [ Time Frame: 52 weeks ]Remission is defined as PCDAI < 10 for CD and PUCAI < 10 for UC. CDAI < 150 and Mayo score ≤2 with no individual subscore > 1
- Medication Usage (change from baseline) [ Time Frame: 52 weeks ]Type and dosage of medication
- Necessity of surgical intervention [ Time Frame: 52 weeks ]Description of type and extent of surgical intervention
- Adherence to therapy (change from baseline) [ Time Frame: 52 weeks ]Assessed by the Morisky Medical Adherence Scale (MASS-8)
- Health care utilization (change from baseline) [ Time Frame: 52 weeks ]Assessed by standardized items derived from the questionnaires and Report of the treating physician.
- Inflammatory markers [ Time Frame: baseline and 12, 24 and 52 weeks ]Inflammatory markers will be measured at all time points (baseline and after 3,6,12 months) Inflammatory markers like BSE, CRP, faecal calprotectin
- Disease perception (change from baseline) [ Time Frame: 12 weeks ]Assesses by the Brief Illness Perceptions Questionnaire (B-IPQ)
- Cognitive coping styles (change from baseline) [ Time Frame: 12 weeks ]Assesses by the Cognitive Emotion Regulation Questionnaire (CERQ)
- Quality of sleep (change from baseline) [ Time Frame: 12 weeks ]Assesses by the Sleep Self-Report (SSR) (10-20 years) PSQI: Pittsburgh Sleep Quality Index (21-25 year)
- Demographic factors [ Time Frame: 12 weeks ]Assesses by the Rotterdam's quality of life interview
- Parental anxiety and depression [ Time Frame: 12 weeks ]Assesses by the Depression, Anxiety and Stress Scale (DASS-21)
- Life Events [ Time Frame: 12 weeks ]Assesses by the Life events questionnaire from CERQ
- Family Functioning (change from baseline) [ Time Frame: 12 weeks ]Assesses by the Family Assessment Device (FAD)
- Disease phenotypes [ Time Frame: 52 weeks ]Assessed by the Paris Classification
- Treatment Strategy [ Time Frame: 52 weeks ]The treatment strategy, type and dosage of medication will be extracted from the medical file and report of the treating physician.
- White blood cell RNA expression profiles (change from baseline) [ Time Frame: 12 weeks ]Assessing immune status is done by analyzing gene expression profiles in peripheral blood leukocytes. This will be performed
- Immunological activity in peripheral blood mononuclear cells (PBMC) [ Time Frame: 12 weeks ]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
- Irritable bowel syndrome -like symptoms [ Time Frame: 12 months ]Assessed by the ROME III diagnostic criteria for IBS in pediatric IBD patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265588
|Erasmus Medical Center|
|Rotterdam, Nederland, Netherlands, 3015CN|
|Study Chair:||Johanna C. Escher, PhD, MD||Erasmus Medical Centre|