Inflammatory Bowel DiseaseNCT00534911
Reducing Depressive Symptoms in Physically Ill Youth
A study testing Cognitive Behavioral Therapy and Supportive Non-directive Therapy (SNDT) in people with Inflammatory Bowel Disease and Depression, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease, Depression
- What is being tested?
- Cognitive Behavioral Therapy and Supportive Non-directive Therapy (SNDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Dec 2019
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Step 1:
- ages 9 to 17 inclusive
- capable of completing CDI
- meeting diagnostic criteria for CD (the date of diagnosis = date of the first diagnostic test confirming CD)
- absence of mental retardation by history
- having at least one appointment at the GI clinic (this will include patients followed in these clinics as well as those seeking consultation)
Show all 10Show fewer
- Step 2:
- CDI or CDI-P greater than or equal to 10 at Step 1.
- ages between 9-17 inclusive
- having CD
Who cannot join
- history or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria
- mental retardation by history
- antidepressant medications within one month of assessment
- suicidality with plan or of severity requiring immediate psychiatric hospitalization or significant act involving intentional self-harm (e.g., cutting or overdose, resulting in medical attention)
- unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons
- current pregnancy by history
Show all 9Show fewer
- substance abuse by history within one month of enrollment other than nicotine dependence
- current treatment with CBT or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider using a manual
- if currently receiving other psychotherapy modalities willingness to suspend treatment for 12-week acute treatment phase of study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital-Boston
Boston, Massachusetts, 02115
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.
Hypothesis
- Individuals who receive CBT will show more improvement than individuals who receive SNDT.
Read the detailed description
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBR, such as steroids, may induce depression. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease and depression. This study will also be the first to assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.
Participants will be carefully evaluated for depression and those who have clinically significant depression will be randomly assigned to either CBT designed for youth with IBD or supportive therapy sessions. Youth in the CBT group will learn new ways of thinking and acting to reduce symptoms of depression focused on the reconstruction of negative or hopeless physical illness narratives. Parents in the CBT group will participate in three family sessions designed to improve family understanding and communication about the physical illness and about risks for developing depression. Children in the supportive therapy condition will receive social support and information about IBD and depression similar to what they would likely receive from social workers in their pediatric medical clinic. Because emotional difficulties such as the experience of depressive symptoms have been linked with the severity and course of IBD symptoms, this information may enable parents to better help their child cope with his/her physical illness. In addition, participants in both groups may experience reduced depression and improved quality of life.
It is predicted that those in the CBT group will benefit by learning effective strategies for coping with IBD and depression, enhancing their social skills, and improving family communication skills while those in the supportive therapy group will benefit by receiving social support and useful information. The proposed study will help determine which psychosocial approach is of greater benefit for depressed youth with IBD and provide a model for integrating behavioral treatment to decrease both emotional and IBD-related suffering into the comprehensive medical care for IBD in the pediatric population.
Aim 1(primary) Are there differences between the two types of therapy in terms of improving depression.
Aim 2 (secondary) Are there differences between the two types of therapy in terms of improving IBD activity, quality of life, and medication adherence? Aim 3) (secondary) Are there differences between the two types of therapy in terms of improving sleep and pain? Aim 4) (exploratory) Are anxiety, steroid use, and gender moderators of treatment outcome.
- Conditions
- Inflammatory Bowel Disease, Depression
- Being tested
- Cognitive Behavioral Therapy, Supportive Non-directive Therapy (SNDT)
- Keywords
- Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.
Other Name: Primary and secondary coping enhancement training (PASCET)
Supportive Non-directive Therapy (SNDT)Behavioural
SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Primary \& Secondary Control Enhancement Training (PASCET) Receives: Behavioral: Cognitive Behavioral Therapy |
| Supportive Non-Directive Therapy (SNDT) | Active comparator | Supportive Non-Directive Therapy Receives: Behavioral: Supportive Non-directive Therapy (SNDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CDRS at 3 months
Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment.
Measured: Month 0, Month 3
Secondary outcomes (1)
Change from baseline in KSADS diagnosis at 3 months
Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment.
Measured: Month 0, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2013
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 PittsburghThe 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Szigethy, University of Pittsburgh
- Investigators
- Eva Szigethy, MD, PhD, Principal investigator, University of Pittsburgh/ Children's Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534911
- Sponsor's protocol ID
- 0606136
- Status last verified
- Jan 2020
- First submitted
- 21 Sep 2007
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 40243391Keerthy D, Youk A, Srinath AI, Malas N, Bujoreanu S, Bousvaros A, Keljo D, DeMaso DR, Szigethy EM. Effect of Psychotherapy on Health Care Utilization in Children With Inflammatory Bowel Disease and Depression. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):658-664. doi: 10.1097/MPG.0000000000001207.
PubMed 27035372Szigethy E, Youk AO, Gonzalez-Heydrich J, Bujoreanu SI, Weisz J, Fairclough D, Ducharme P, Jones N, Lotrich F, Keljo D, Srinath A, Bousvaros A, Kupfer D, DeMaso DR. Effect of 2 psychotherapies on depression and disease activity in pediatric Crohn's disease. Inflamm Bowel Dis. 2015 Jun;21(6):1321-8. doi: 10.1097/MIB.0000000000000358.
PubMed 25822010Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis. 2014 Dec;20(12):2433-49. doi: 10.1097/MIB.0000000000000170.
PubMed 25208108Szigethy E, Bujoreanu SI, Youk AO, Weisz J, Benhayon D, Fairclough D, Ducharme P, Gonzalez-Heydrich J, Keljo D, Srinath A, Bousvaros A, Kirshner M, Newara M, Kupfer D, DeMaso DR. Randomized efficacy trial of two psychotherapies for depression in youth with inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):726-35. doi: 10.1016/j.jaac.2014.04.014. Epub 2014 May 10.
PubMed 24954822
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Depressive Symptoms in Physically Ill Youth
- ClinicalTrials.gov ID
- NCT00534911
- Acronym / sponsor ID
- 0606136
- Conditions
- Inflammatory Bowel Disease, Depression
- Keywords
- Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Sep 2007 (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.
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.
Hypothesis
- Individuals who receive CBT will show more improvement than individuals who receive SNDT.
Detailed description
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBR, such as steroids, may induce depression. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease and depression. This study will also be the first to assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.
Participants will be carefully evaluated for depression and those who have clinically significant depression will be randomly assigned to either CBT designed for youth with IBD or supportive therapy sessions. Youth in the CBT group will learn new ways of thinking and acting to reduce symptoms of depression focused on the reconstruction of negative or hopeless physical illness narratives. Parents in the CBT group will participate in three family sessions designed to improve family understanding and communication about the physical illness and about risks for developing depression. Children in the supportive therapy condition will receive social support and information about IBD and depression similar to what they would likely receive from social workers in their pediatric medical clinic. Because emotional difficulties such as the experience of depressive symptoms have been linked with the severity and course of IBD symptoms, this information may enable parents to better help their child cope with his/her physical illness. In addition, participants in both groups may experience reduced depression and improved quality of life.
It is predicted that those in the CBT group will benefit by learning effective strategies for coping with IBD and depression, enhancing their social skills, and improving family communication skills while those in the supportive therapy group will benefit by receiving social support and useful information. The proposed study will help determine which psychosocial approach is of greater benefit for depressed youth with IBD and provide a model for integrating behavioral treatment to decrease both emotional and IBD-related suffering into the comprehensive medical care for IBD in the pediatric population.
Aim 1(primary) Are there differences between the two types of therapy in terms of improving depression.
Aim 2 (secondary) Are there differences between the two types of therapy in terms of improving IBD activity, quality of life, and medication adherence? Aim 3) (secondary) Are there differences between the two types of therapy in terms of improving sleep and pain? Aim 4) (exploratory) Are anxiety, steroid use, and gender moderators of treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyPrimary \& Secondary Control Enhancement Training (PASCET) |
| Supportive Non-Directive Therapy (SNDT) | Active comparator | Behavioral: Supportive Non-directive Therapy (SNDT)Supportive Non-Directive Therapy |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- ages 9 to 17 inclusive
- capable of completing CDI
- meeting diagnostic criteria for CD (the date of diagnosis = date of the first diagnostic test confirming CD)
- absence of mental retardation by history
- having at least one appointment at the GI clinic (this will include patients followed in these clinics as well as those seeking consultation)
Key exclusion criteria (9 listed)
- history or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria
- mental retardation by history
- antidepressant medications within one month of assessment
- suicidality with plan or of severity requiring immediate psychiatric hospitalization or significant act involving intentional self-harm (e.g., cutting or overdose, resulting in medical attention)
- unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons
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 TherapyParticipants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up. Other Name: Primary and secondary coping enhancement training (PASCET) | Behavioural | Cognitive Behavioral Therapy |
| Supportive Non-directive Therapy (SNDT)SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up. | Behavioural | Supportive Non-Directive Therapy (SNDT) |
Primary outcome
Change from baseline in CDRS at 3 months
Time frame: Month 0, Month 3
Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment.
1 secondary outcome
Change from baseline in KSADS diagnosis at 3 months
Time frame: Month 0, Month 3
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 7 Jan 2020.
- 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 27035372Keerthy D, Youk A, Srinath AI, Malas N, Bujoreanu S, Bousvaros A, Keljo D, DeMaso DR, Szigethy EM. Effect of Psychotherapy on Health Care Utilization in Children With Inflammatory Bowel Disease and Depression. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):658-664. doi: 10.1097/MPG.0000000000001207.
- Derived from this study: PubMed 25822010Szigethy E, Youk AO, Gonzalez-Heydrich J, Bujoreanu SI, Weisz J, Fairclough D, Ducharme P, Jones N, Lotrich F, Keljo D, Srinath A, Bousvaros A, Kupfer D, DeMaso DR. Effect of 2 psychotherapies on depression and disease activity in pediatric Crohn's disease. Inflamm Bowel Dis. 2015 Jun;21(6):1321-8. doi: 10.1097/MIB.0000000000000358.
- Derived from this study: PubMed 25208108Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis. 2014 Dec;20(12):2433-49. doi: 10.1097/MIB.0000000000000170.
- Derived from this study: PubMed 24954822Szigethy E, Bujoreanu SI, Youk AO, Weisz J, Benhayon D, Fairclough D, Ducharme P, Gonzalez-Heydrich J, Keljo D, Srinath A, Bousvaros A, Kirshner M, Newara M, Kupfer D, DeMaso DR. Randomized efficacy trial of two psychotherapies for depression in youth with inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):726-35. doi: 10.1016/j.jaac.2014.04.014. Epub 2014 May 10.
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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.
Eva Szigethy, MD, PhD principal investigator
University of Pittsburgh/ Children's Hospital of Pittsburgh
2 sites 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 and Supportive Non-directive Therapy (SNDT) in people with Inflammatory Bowel Disease and Depression, run by University of Pittsburgh at 2 sites in United States.
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 10 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Change from baseline in CDRS at 3 months (time frame: Month 0, Month 3). 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 NCT00534911, which also lists 5 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 7 Jan 2020.