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

Depression Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265588
• Other study ID #: NL49147.078.14
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 24, 2017

Study information

• Verified date: July 2022
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 24, 2017
• Est. primary completion date: October 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Depression
• Depressive Disorder
• Inflammatory Bowel Disease (IBD)
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Nederland

Sponsors (7)

Lead Sponsor	Collaborator
Erasmus Medical Center	Albert Schweitzer Hospital, Amphia Hospital, Haga Hospital, Leiden University Medical Center, Maasstad Hospital, Reinier de Graaf Groep

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease perception (change from baseline)	Assesses by the Brief Illness Perceptions Questionnaire (B-IPQ)	12 weeks
Other	Cognitive coping styles (change from baseline)	Assesses by the Cognitive Emotion Regulation Questionnaire (CERQ)	12 weeks
Other	Quality of sleep (change from baseline)	Assesses by the Sleep Self-Report (SSR) (10-20 years) PSQI: Pittsburgh Sleep Quality Index (21-25 year)	12 weeks
Other	Demographic factors	Assesses by the Rotterdam's quality of life interview	12 weeks
Other	Parental anxiety and depression	Assesses by the Depression, Anxiety and Stress Scale (DASS-21)	12 weeks
Other	Life Events	Assesses by the Life events questionnaire from CERQ	12 weeks
Other	Family Functioning (change from baseline)	Assesses by the Family Assessment Device (FAD)	12 weeks
Other	Disease phenotypes	Assessed by the Paris Classification	52 weeks
Other	Treatment Strategy	The treatment strategy, type and dosage of medication will be extracted from the medical file and report of the treating physician.	52 weeks
Other	White blood cell RNA expression profiles (change from baseline)	Assessing immune status is done by analyzing gene expression profiles in peripheral blood leukocytes. This will be performed	12 weeks
Other	Immunological activity in peripheral blood mononuclear cells (PBMC)	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
Other	Irritable bowel syndrome -like symptoms	Assessed by the ROME III diagnostic criteria for IBS in pediatric IBD patients	12 months
Primary	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	Reduction in symptoms of anxiety (change from baseline)	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
Secondary	General Quality of Life	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
Secondary	Social Skills	Assessed by Social Skills Rating System (SSRS) (10-20years) Novotni SSC: Social Skills Checklist (21-25 year)	12 weeks
Secondary	Social competence	Assessed by Youth Self Report (YSR) / Adult Self Report (ASR)	12 weeks
Secondary	Disease specific quality of life	Assessed by the IMPACT-III-NL (10-20years) IBDQ: Inflammatory Bowel Disease Questionnaire (21-25 year)	12 weeks and 52 weeks
Secondary	Disease Activity	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
Secondary	Clinical relapse (number of flares)	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
Secondary	Maintaining remission	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
Secondary	Medication Usage (change from baseline)	Type and dosage of medication	52 weeks
Secondary	Necessity of surgical intervention	Description of type and extent of surgical intervention	52 weeks
Secondary	Adherence to therapy (change from baseline)	Assessed by the Morisky Medical Adherence Scale (MASS-8)	52 weeks
Secondary	Health care utilization (change from baseline)	Assessed by standardized items derived from the questionnaires and Report of the treating physician.	52 weeks
Secondary	Inflammatory markers	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