Clinical trial NCT02265588: Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Ulcerative Colitis
Crohn's Disease
Anxiety
Depression
Keywords: Inflammatory bowel disease (IBD)
Ulcerative colitis
Crohn's disease
Children
Adolescents
Anxiety
Depression
Cognitive behavioral therapy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Reinier de Graaf Groep
name: Albert Schweitzer Hospital
name: Maasstad Hospital
name: Haga Hospital
name: Amphia Hospital
name: Leiden University Medical Center
First posted: 2014-10-16
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in symptoms of depression (change from baseline)
timeFrame: 12 weeks and 52 weeks
Secondary outcomes:
measure: Reduction in symptoms of anxiety (change from baseline)
timeFrame: 12 weeks and 52 weeks
measure: General Quality of Life
timeFrame: 12 weeks and 52 weeks
measure: Social Skills
timeFrame: 12 weeks
measure: Social competence
timeFrame: 12 weeks
measure: Disease specific quality of life
timeFrame: 12 weeks and 52 weeks
measure: Disease Activity
timeFrame: 52 weeks
measure: Clinical relapse (number of flares)
timeFrame: 52 weeks
measure: Maintaining remission
timeFrame: 52 weeks
measure: Medication Usage (change from baseline)
timeFrame: 52 weeks
measure: Necessity of surgical intervention
timeFrame: 52 weeks
measure: Adherence to therapy (change from baseline)
timeFrame: 52 weeks
measure: Health care utilization (change from baseline)
timeFrame: 52 weeks
measure: Inflammatory markers
timeFrame: baseline and 12, 24 and 52 weeks
Other outcomes:
measure: Disease perception (change from baseline)
timeFrame: 12 weeks
measure: Cognitive coping styles (change from baseline)
timeFrame: 12 weeks
measure: Quality of sleep (change from baseline)
timeFrame: 12 weeks
measure: Demographic factors
timeFrame: 12 weeks
measure: Parental anxiety and depression
timeFrame: 12 weeks
measure: Life Events
timeFrame: 12 weeks
measure: Family Functioning (change from baseline)
timeFrame: 12 weeks
measure: Disease phenotypes
timeFrame: 52 weeks
measure: Treatment Strategy
timeFrame: 52 weeks
measure: White blood cell RNA expression profiles (change from baseline)
timeFrame: 12 weeks
measure: Immunological activity in peripheral blood mononuclear cells (PBMC)
timeFrame: 12 weeks
measure: Irritable bowel syndrome -like symptoms
timeFrame: 12 months
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Nederland
Study officials:
affiliation: Erasmus Medical Centre
name: Johanna C. Escher, PhD, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.