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

July 26, 2022 updated by: J.C. Escher, M.D., Ph.D, Erasmus Medical Center

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.

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.

Study Overview

Detailed Description

  1. 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.
  2. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nederland
      • Rotterdam, Nederland, Netherlands, 3015CN
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks and 52 weeks
General 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)
12 weeks and 52 weeks
Social Skills
Time Frame: 12 weeks
Assessed by Social Skills Rating System (SSRS) (10-20years) Novotni SSC: Social Skills Checklist (21-25 year)
12 weeks
Social competence
Time Frame: 12 weeks
Assessed by Youth Self Report (YSR) / Adult Self Report (ASR)
12 weeks
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)
12 weeks and 52 weeks
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)
52 weeks
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

52 weeks
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
52 weeks
Medication Usage (change from baseline)
Time Frame: 52 weeks
Type and dosage of medication
52 weeks
Necessity of surgical intervention
Time Frame: 52 weeks
Description of type and extent of surgical intervention
52 weeks
Adherence to therapy (change from baseline)
Time Frame: 52 weeks
Assessed by the Morisky Medical Adherence Scale (MASS-8)
52 weeks
Health care utilization (change from baseline)
Time Frame: 52 weeks
Assessed by standardized items derived from the questionnaires and Report of the treating physician.
52 weeks
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
baseline and 12, 24 and 52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease perception (change from baseline)
Time Frame: 12 weeks
Assesses by the Brief Illness Perceptions Questionnaire (B-IPQ)
12 weeks
Cognitive coping styles (change from baseline)
Time Frame: 12 weeks
Assesses by the Cognitive Emotion Regulation Questionnaire (CERQ)
12 weeks
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)
12 weeks
Demographic factors
Time Frame: 12 weeks
Assesses by the Rotterdam's quality of life interview
12 weeks
Parental anxiety and depression
Time Frame: 12 weeks
Assesses by the Depression, Anxiety and Stress Scale (DASS-21)
12 weeks
Life Events
Time Frame: 12 weeks
Assesses by the Life events questionnaire from CERQ
12 weeks
Family Functioning (change from baseline)
Time Frame: 12 weeks
Assesses by the Family Assessment Device (FAD)
12 weeks
Disease phenotypes
Time Frame: 52 weeks
Assessed by the Paris Classification
52 weeks
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.
52 weeks
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
12 weeks
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
12 weeks
Irritable bowel syndrome -like symptoms
Time Frame: 12 months
Assessed by the ROME III diagnostic criteria for IBS in pediatric IBD patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Johanna C. Escher, PhD, MD, Erasmus Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

August 24, 2017

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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