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| Name | Class |
|---|---|
| Harvard University | OTHER |
| Boston Children's Hospital | OTHER |
| National Institutes of Health (NIH) | NIH |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | CBT enhanced with physical illness narrative, family education, and social skills components. |
|
| Standard of Community Care Treatment | Active Comparator | Standard of Community Care Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | CBT enhanced with physical illness narrative, family education, and social skills components. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in CDI at 14 weeks | Change in Childhood Depression Inventory (CDI) scores from week 0 to study endpoint, week 14 | Week 0, Week 14 |
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Inclusion Criteria:
Step One
Step Two: Assessment
1) CDI and/or CDI-P equal to or more than 9 at Step 1
At Intervention Phase
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Szigethy, MD, PhD | University of Pittsburgh / Children's Hospital of Pittsburgh | Principal Investigator |
| David DeMaso, MD | Harvard University / Children's Hospital Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States | ||
| Children's Hospital of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16601643 | Result | 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. | |
| 15564816 | Result | Szigethy 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. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Standard of Community Care Treatment | Behavioral | Treatment as usual for depression and related symptoms provided within the community. |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 40243391 | Derived | 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. |
| 17885570 | Derived | 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. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |