Inflammatory Bowel Disease (IBD)HAPPY-IBDNCT02265588
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
A study testing Cognitive behavioral therapy in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to 24 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between 10-25 years with diagnosed IBD
- Informed consent or assent by patients and (if necessary) parents
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed description
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- Conditions
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's Disease, Anxiety, Depression
- Being tested
- Cognitive behavioral therapy
- Keywords
- Inflammatory bowel disease (IBD), Ulcerative colitis, Crohn's disease, Children, Adolescents, Anxiety, Depression, Cognitive behavioral therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks and 52 weeks
Secondary outcomes (13)
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)
Measured: 12 weeks and 52 weeks
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)
Measured: 12 weeks and 52 weeks
Social Skills
Assessed by Social Skills Rating System (SSRS) (10-20years) Novotni SSC: Social Skills Checklist (21-25 year)
Measured: 12 weeks
Social competence
Assessed by Youth Self Report (YSR) / Adult Self Report (ASR)
Measured: 12 weeks
Disease specific quality of life
Assessed by the IMPACT-III-NL (10-20years) IBDQ: Inflammatory Bowel Disease Questionnaire (21-25 year)
Measured: 12 weeks and 52 weeks
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)
Measured: 52 weeks
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
Measured: 52 weeks
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
Measured: 52 weeks
Medication Usage (change from baseline)
Type and dosage of medication
Measured: 52 weeks
Necessity of surgical intervention
Description of type and extent of surgical intervention
Measured: 52 weeks
Adherence to therapy (change from baseline)
Assessed by the Morisky Medical Adherence Scale (MASS-8)
Measured: 52 weeks
Health care utilization (change from baseline)
Assessed by standardized items derived from the questionnaires and Report of the treating physician.
Measured: 52 weeks
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
Measured: baseline and 12, 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion1 Oct 2016
- Study completion24 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Reinier de Graaf Groep, Albert Schweitzer Hospital, Maasstad Hospital, Haga Hospital, Amphia Hospital, Leiden University Medical Center
- Responsible party
- Principal investigator, J.C. Escher, M.D., Ph.D, Erasmus Medical Center
- Investigators
- Johanna C. Escher, PhD, MD, Study chair, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265588
- Sponsor's protocol ID
- NL49147.078.14
- Acronym
- HAPPY-IBD
- Status last verified
- Jul 2022
- First submitted
- 10 Oct 2014
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17885570Thompson 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.
PubMed 22699797Tiles-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.
PubMed 40243391Stapersma 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.
PubMed 31506853Stapersma 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.
PubMed 29850915van 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.
PubMed 26966551
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02265588
- Acronym / sponsor ID
- HAPPY-IBD / NL49147.078.14
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Reinier de Graaf Groep, Albert Schweitzer Hospital, Maasstad Hospital, Haga Hospital, Amphia Hospital, Leiden University Medical Center
- Study start
- Sep 2014 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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).
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Cognitive behavioral therapyThe 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. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients between 10-25 years with diagnosed IBD
- Informed consent or assent by patients and (if necessary) parents
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyA 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. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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)
13 secondary outcomes
Reduction in symptoms of anxiety (change from baseline)
Time frame: 12 weeks and 52 weeks
General Quality of Life
Time frame: 12 weeks and 52 weeks
Social Skills
Time frame: 12 weeks
Social competence
Time frame: 12 weeks
Disease specific quality of life
Time frame: 12 weeks and 52 weeks
Disease Activity
Time frame: 52 weeks
Clinical relapse (number of flares)
Time frame: 52 weeks
Maintaining remission
Time frame: 52 weeks
Medication Usage (change from baseline)
Time frame: 52 weeks
Necessity of surgical intervention
Time frame: 52 weeks
Adherence to therapy (change from baseline)
Time frame: 52 weeks
Health care utilization (change from baseline)
Time frame: 52 weeks
Inflammatory markers
Time frame: baseline and 12, 24 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 17885570Szigethy 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.
- Background: PubMed 22699797Thompson 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.
- Derived from this study: PubMed 40243391Tiles-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.
- Derived from this study: PubMed 31506853Stapersma 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.
- Derived from this study: PubMed 29850915Stapersma 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.
- Derived from this study: PubMed 26966551van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna C. Escher, PhD, MD study chair
Erasmus Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Inflammatory Bowel Disease (IBD) and Ulcerative Colitis, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in symptoms of depression (change from baseline) (time frame: 12 weeks and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265588, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.