Inflammatory Bowel DiseaseManaging IBDNCT00679003
Managing Inflammatory Bowel Disease
A study testing SLCBT and ES in people with Inflammatory Bowel Disease and Crohn's Disease, run by University of Washington.
Trial summary
Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- SLCBT and ES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Mar 2014
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child has been diagnosed for at least 3 months
- Child age is 8-17
- Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime
- Child is medically approved to engage in normal daily activities
Who cannot join
- Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy)
- Major surgery in past year unrelated to IBD
- Developmental disabilities that require full-time special education or that impair ability to respond to treatment
About this study
Official title: Psychosocial Intervention for Children With IBD
Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.
Read the detailed description
Inflammatory Bowel Disease (Crohn's and ulcerative colitis; IBD), a serious medical condition that affects children and adolescents, is often associated with high rates of health care utilization and disability, including school absences. While psychosocial factors are not believed to cause IBD, research suggests that they may increase illness-related dysfunction. Prior studies suggest that response to chronic illness is, in part, acquired during childhood through social learning processes and may be modified with psychosocial interventions. This randomized controlled trial will compare a social learning and cognitive behavior therapy (SLCBT) treatment to an education and support condition (ES). 180 children with IBD will be recruited and followed for 12 months. It is hypothesized that SLCBT participants, compared to those in the ES condition, will, at one-year follow-up: 1) exhibit greater decreases in IBD symptoms, medical visits for IBD, and functional disability, and greater increases in quality of life; 2) demonstrate greater use of cognitive coping, relaxation and stress management skills, and their parents will demonstrate greater reductions in maladaptive responses to illness behavior; and 3) exhibit greater reductions in anxiety, depression, and somatization. Results will lead to innovative interventions for IBD and other chronic childhood medical conditions.
- Being tested
- SLCBT, ES
- Keywords
- Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Illness behavior, Cognitive behavioral therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLCBTBehavioural
Social learning and cognitive behavioral therapy
ESBehavioural
Education and support (information about nutrition and gastrointestinal system)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Social learning and cognitive behavioral therapy (SLCBT) Receives: Behavioral: SLCBT |
| 2 | Active comparator | Education and support (ES) Receives: Behavioral: ES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Disability Inventory
Measured: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment
Secondary outcomes (3)
School absences
Measured: Baseline, 3 months, 6 months and 12 months post-treatment
Health care utilization for IBD
Measured: Baseline, 3 months, 6 months and 12 months post-treatment
Pediatric Quality of Life
Measured: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Participant
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Seattle Children's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Rona Levy, University of Washington
- Investigators
- Rona L Levy, MSW, PhD, MPH, Principal investigator, University of WashingtonTasha B Murphy, PhD, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679003
- Sponsor's protocol ID
- CHRMC12395
- Other IDs
- 1R01HD050345-01A2
- Acronym
- Managing IBD
- Status last verified
- Apr 2015
- First submitted
- 14 May 2008
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40243391van Tilburg MAL, Claar RL, Romano JM, Langer SL, Drossman DA, Whitehead WE, Abdullah B, Levy RL. Psychological Factors May Play an Important Role in Pediatric Crohn's Disease Symptoms and Disability. J Pediatr. 2017 May;184:94-100.e1. doi: 10.1016/j.jpeds.2017.01.058. Epub 2017 Feb 24.
PubMed 28238483
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention for Children With IBD
- ClinicalTrials.gov ID
- NCT00679003
- Acronym / sponsor ID
- Managing IBD / CHRMC12395
- Keywords
- Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Illness behavior, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Seattle Children's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 May 2008 (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.
Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.
Detailed description
Inflammatory Bowel Disease (Crohn's and ulcerative colitis; IBD), a serious medical condition that affects children and adolescents, is often associated with high rates of health care utilization and disability, including school absences. While psychosocial factors are not believed to cause IBD, research suggests that they may increase illness-related dysfunction. Prior studies suggest that response to chronic illness is, in part, acquired during childhood through social learning processes and may be modified with psychosocial interventions. This randomized controlled trial will compare a social learning and cognitive behavior therapy (SLCBT) treatment to an education and support condition (ES). 180 children with IBD will be recruited and followed for 12 months. It is hypothesized that SLCBT participants, compared to those in the ES condition, will, at one-year follow-up: 1) exhibit greater decreases in IBD symptoms, medical visits for IBD, and functional disability, and greater increases in quality of life; 2) demonstrate greater use of cognitive coping, relaxation and stress management skills, and their parents will demonstrate greater reductions in maladaptive responses to illness behavior; and 3) exhibit greater reductions in anxiety, depression, and somatization. Results will lead to innovative interventions for IBD and other chronic childhood medical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: SLCBTSocial learning and cognitive behavioral therapy (SLCBT) |
| 2 | Active comparator | Behavioral: ESEducation and support (ES) |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child has been diagnosed for at least 3 months
- Child age is 8-17
- Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime
- Child is medically approved to engage in normal daily activities
Key exclusion criteria (3 listed)
- Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy)
- Major surgery in past year unrelated to IBD
- Developmental disabilities that require full-time special education or that impair ability to respond to treatment
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 |
|---|---|---|
| SLCBTSocial learning and cognitive behavioral therapy | Behavioural | 1 |
| ESEducation and support (information about nutrition and gastrointestinal system) | Behavioural | 2 |
Primary outcome
Functional Disability Inventory
Time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment
3 secondary outcomes
School absences
Time frame: Baseline, 3 months, 6 months and 12 months post-treatment
Health care utilization for IBD
Time frame: Baseline, 3 months, 6 months and 12 months post-treatment
Pediatric Quality of Life
Time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12 months post-treatment
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 15 Apr 2015.
- 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 28238483van Tilburg MAL, Claar RL, Romano JM, Langer SL, Drossman DA, Whitehead WE, Abdullah B, Levy RL. Psychological Factors May Play an Important Role in Pediatric Crohn's Disease Symptoms and Disability. J Pediatr. 2017 May;184:94-100.e1. doi: 10.1016/j.jpeds.2017.01.058. Epub 2017 Feb 24.
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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.
Rona L Levy, MSW, PhD, MPH principal investigator
University of Washington
Tasha B Murphy, PhD study director
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing SLCBT and ES in people with Inflammatory Bowel Disease and Crohn's Disease, run by University of Washington.
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 4 inclusion and 3 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional Disability Inventory (time frame: Baseline (1 week pre-treatment), 1 week post-treatment, 3 months, 6 months and 12-months post-treatment). 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 NCT00679003, which also lists 2 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 15 Apr 2015; AzTrials last refreshed its copy on 27 Oct 2026.