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

NCT02265588 | Completed

• 1 other identifier: NL49147.078.14
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Reduction in symptoms of anxiety (change from baseline)

  12 weeks and 52 weeks

• General Quality of Life

  12 weeks and 52 weeks

• Social Skills

  12 weeks

• Social competence

  12 weeks

• Disease specific quality of life

  12 weeks and 52 weeks

Other Outcomes (12)

• Disease perception (change from baseline)

  12 weeks

• Cognitive coping styles (change from baseline)

  12 weeks

• Quality of sleep (change from baseline)

  12 weeks

Study Arms (2)

Care as usual

NO INTERVENTION

Care as usual means receiving their regular medical care. This consists of the regular follow up visits at the gastroenterologist every 3 months.

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Interventions

Cognitive behavioral therapy BEHAVIORAL

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.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 10-25 years with diagnosed IBD
• Informed consent or assent by patients and (if necessary) parents

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Reinier de Graaf Groep: collaborator
• Albert Schweitzer Hospital: collaborator
• Maasstad Hospital: collaborator
• Haga Hospital: collaborator
• Amphia Hospital: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, Nederland, 3015CN, Netherlands

Location

Related Publications (6)

• 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.

  PMID: 17885570 BACKGROUND

• 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.

  PMID: 22699797 BACKGROUND

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.

  PMID: 40243391 DERIVED

• 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.

  PMID: 31506853 DERIVED

• 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.

  PMID: 29850915 DERIVED

• 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.

  PMID: 26966551 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Anxiety Disorders; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Johanna C. Escher, PhD, MD

  Erasmus Medical Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. J.C. Escher, PhD, pediatric gastroenterologist

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 16, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: August 24, 2017
• Last Updated: July 28, 2022

Record last verified: 2022-07

Locations

NL (1)