Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
Condition: Inflammatory Bowel Disease (IBD); Ulcerative Colitis; Crohn's Disease; Anxiety; Depression
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammatory bowel disease (IBD); Ulcerative colitis; Crohn's disease; Children; Adolescents; Anxiety; Depression; Cognitive behavioral therapy