Inflammatory Bowel DiseaseNCT00446238
Treatment of Depressed Adolescents With Physical Illness
A study testing Cognitive Behavioral Therapy and Standard of Community Care Treatment in people with Inflammatory Bowel Disease and Depression, run by University of Pittsburgh at 2 sites in United States.
Trial summary
The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI) for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time of randomization into the study. Hypotheses 1. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease, Depression
- What is being tested?
- Cognitive Behavioral Therapy and Standard of Community Care Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2002to Aug 2007
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Step One
- Ages 11 to 17 inclusive.
- Capable of completing CDI
- English-speaking.
- Meeting diagnostic criteria for IBD (The date of diagnosis = date of the first diagnostic test confirming IBD)
- Absence of mental retardation by history
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- Having at least one appointment at the gastroenterology clinic at CHP.
- Step Two: Assessment
- 1) CDI and/or CDI-P equal to or more than 9 at Step 1
- At Intervention Phase
- CDI score equal to or more than 9 AND/OR CDI-P score equal to or more than 9 at T0.
- Absence of recent suicide attempt (within one month of study enrollment) or depression severity requiring acute psychiatric hospitalization),
- Age 11-17 years inclusive,
- Presence of at least one biological parent.
Who cannot join
- Current major depression or dysthymia by Diagnostic and Statistical Manual (DSM)-IV criteria
- History or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria.
- Mental retardation by history
- Antidepressant or stimulant 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.
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- Current pregnancy by history.
- Substance abuse within one month of enrollment other than nicotine dependence.
- Current treatment with cognitive behavioral therapy (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.
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
The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI) for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time of randomization into the study.
Hypotheses
- This preliminary randomized trial will demonstrate the feasibility of a large-scale research initiative.
- Subjects will experience no adverse events, and the CBI group will demonstrate improved negative cognitions, depressive symptomatology, and functioning at the post-intervention and 6- through 12-month follow-ups.
Read the detailed description
This study is a pilot study, which will serve to determine the feasibility of a larger research initiative. The broader research is aimed at the prevention of depressive disorders in adolescents with inflammatory bowel disease (IBD) who have risk factors for depression, using a psychotherapeutic intervention. The intervention is based on a cognitive-behavioral approach to treating depression, the Primary and Secondary Control Enhancement Training (PASCET), that has been modified and enhanced with physical illness narrative, social skills, and family components (PASCET-Physical Illness), to make it more appropriate for physically ill adolescents at risk for major depression. The cognitive-behavioral intervention (CBI) draws on an etiological hypothesis that depression in adolescents with chronic physical illness results from cumulative risk factors such as distorted cognitive processes, negative physical illness experience, poor social functioning, and ineffective family interactions. Thus, the development of depression may be prevented by teaching adolescents effective strategies to 1) cope using cognitive-behavioral skills, 2) enhance social functioning, 3) develop a more cohesive illness narrative, and 4) improve family communication skills.
The study is a randomized trial of the CBI for adolescents with IBD and depressive symptoms, using the provision of psychoeducational materials as the attention control group. This study is a pilot study designed to show feasibility of assessing and treating youth with sub-syndromal depressive symptoms and IBD using a randomized clinical design at Children's Hospital Pittsburgh (CHP) as a preliminary step for designing a two-site randomized trial Children's Hospital of Pittsburgh and Children's Hospital Boston powered to test preventive effects of this CBI in this medically co-morbid population.
In this study, eligible adolescents who are at risk for developing depression due to having a chronic physical illness (IBD) as well as having subsyndromal depressive symptoms but who do not currently meet diagnostic criteria for major depressive disorder according to a diagnostic interview will be randomly assigned either to receive CBI or psychoeducation.
- Conditions
- Inflammatory Bowel Disease, Depression
- Being tested
- Cognitive Behavioral Therapy, Standard of Community Care Treatment
- 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
CBT enhanced with physical illness narrative, family education, and social skills components.
Standard of Community Care TreatmentBehavioural
Treatment as usual for depression and related symptoms provided within the community.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | CBT enhanced with physical illness narrative, family education, and social skills components. Receives: Behavioral: Cognitive Behavioral Therapy |
| Standard of Community Care Treatment | Active comparator | Standard of Community Care Treatment Receives: Behavioral: Standard of Community Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in CDI at 14 weeks
Change in Childhood Depression Inventory (CDI) scores from week 0 to study endpoint, week 14
Measured: Week 0, Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startSep 2002
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Boston Children's Hospital, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Eva Szigethy, University of Pittsburgh
- Investigators
- Eva Szigethy, MD, PhD, Principal investigator, University of Pittsburgh / Children's Hospital of PittsburghDavid DeMaso, MD, Principal investigator, Harvard University / Children's Hospital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446238
- Sponsor's protocol ID
- 1K23MH064604-01A1
- Status last verified
- May 2014
- First submitted
- 8 Mar 2007
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szigethy E, Carpenter J, Baum E, Kenney E, Baptista-Neto L, Beardslee WR, Demaso DR. Case study: longitudinal treatment of adolescents with depression and inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):396-400. doi: 10.1097/01.chi.0000198591.45949.a4.
PubMed 16601643Szigethy E, Whitton SW, Levy-Warren A, DeMaso DR, Weisz J, Beardslee WR. Cognitive-behavioral therapy for depression in adolescents with inflammatory bowel disease: a pilot study. J Am Acad Child Adolesc Psychiatry. 2004 Dec;43(12):1469-77. doi: 10.1097/01.chi.0000142284.10574.1f.
PubMed 15564816Tiles-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 40243391Szigethy 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 17885570
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Depressed Adolescents With Physical Illness
- ClinicalTrials.gov ID
- NCT00446238
- Acronym / sponsor ID
- 1K23MH064604-01A1
- Conditions
- Inflammatory Bowel Disease, Depression
- Keywords
- Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Harvard University, Boston Children's Hospital, National Institutes of Health (NIH)
- Study start
- Sep 2002
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 12 Mar 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.
The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI) for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time of randomization into the study.
Hypotheses
- This preliminary randomized trial will demonstrate the feasibility of a large-scale research initiative.
- Subjects will experience no adverse events, and the CBI group will demonstrate improved negative cognitions, depressive symptomatology, and functioning at the post-intervention and 6- through 12-month follow-ups.
Detailed description
This study is a pilot study, which will serve to determine the feasibility of a larger research initiative. The broader research is aimed at the prevention of depressive disorders in adolescents with inflammatory bowel disease (IBD) who have risk factors for depression, using a psychotherapeutic intervention. The intervention is based on a cognitive-behavioral approach to treating depression, the Primary and Secondary Control Enhancement Training (PASCET), that has been modified and enhanced with physical illness narrative, social skills, and family components (PASCET-Physical Illness), to make it more appropriate for physically ill adolescents at risk for major depression. The cognitive-behavioral intervention (CBI) draws on an etiological hypothesis that depression in adolescents with chronic physical illness results from cumulative risk factors such as distorted cognitive processes, negative physical illness experience, poor social functioning, and ineffective family interactions. Thus, the development of depression may be prevented by teaching adolescents effective strategies to 1) cope using cognitive-behavioral skills, 2) enhance social functioning, 3) develop a more cohesive illness narrative, and 4) improve family communication skills.
The study is a randomized trial of the CBI for adolescents with IBD and depressive symptoms, using the provision of psychoeducational materials as the attention control group. This study is a pilot study designed to show feasibility of assessing and treating youth with sub-syndromal depressive symptoms and IBD using a randomized clinical design at Children's Hospital Pittsburgh (CHP) as a preliminary step for designing a two-site randomized trial Children's Hospital of Pittsburgh and Children's Hospital Boston powered to test preventive effects of this CBI in this medically co-morbid population.
In this study, eligible adolescents who are at risk for developing depression due to having a chronic physical illness (IBD) as well as having subsyndromal depressive symptoms but who do not currently meet diagnostic criteria for major depressive disorder according to a diagnostic interview will be randomly assigned either to receive CBI or psychoeducation.
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 TherapyCBT enhanced with physical illness narrative, family education, and social skills components. |
| Standard of Community Care Treatment | Active comparator | Behavioral: Standard of Community Care TreatmentStandard of Community Care Treatment |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Step One
- Step Two: Assessment
- 1) CDI and/or CDI-P equal to or more than 9 at Step 1
- At Intervention Phase
Key exclusion criteria (9 listed)
- Current major depression or dysthymia by Diagnostic and Statistical Manual (DSM)-IV criteria
- History or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria.
- Mental retardation by history
- Antidepressant or stimulant 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.
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 TherapyCBT enhanced with physical illness narrative, family education, and social skills components. | Behavioural | Cognitive Behavioral Therapy |
| Standard of Community Care TreatmentTreatment as usual for depression and related symptoms provided within the community. | Behavioural | Standard of Community Care Treatment |
Primary outcome
Change from Baseline in CDI at 14 weeks
Time frame: Week 0, Week 14
Change in Childhood Depression Inventory (CDI) scores from week 0 to study endpoint, week 14
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 20 May 2014.
- Results publication: PubMed 16601643Szigethy E, Carpenter J, Baum E, Kenney E, Baptista-Neto L, Beardslee WR, Demaso DR. Case study: longitudinal treatment of adolescents with depression and inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2006 Apr;45(4):396-400. doi: 10.1097/01.chi.0000198591.45949.a4.
- Results publication: PubMed 15564816Szigethy E, Whitton SW, Levy-Warren A, DeMaso DR, Weisz J, Beardslee WR. Cognitive-behavioral therapy for depression in adolescents with inflammatory bowel disease: a pilot study. J Am Acad Child Adolesc Psychiatry. 2004 Dec;43(12):1469-77. doi: 10.1097/01.chi.0000142284.10574.1f.
- 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 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.
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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
David DeMaso, MD principal investigator
Harvard University / Children's Hospital Boston
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 Standard of Community Care Treatment 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 14 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 20 May 2014. 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 CDI at 14 weeks (time frame: Week 0, Week 14). 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 NCT00446238, which also lists 4 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 20 May 2014.