Treatment of Depressed Adolescents With Physical Illness - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Children's Hospital of Pittsburgh Harvard University Children's Hospital Boston National Institutes of Health (NIH)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00446238

Purpose

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.

Condition	Intervention
Inflammatory Bowel Disease Subsyndromal Depression	Behavioral: PASCET - a manual-based Cognitive Behavorial Therapy

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Depressed Adolescents With Physical Illness

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Schedule for Affective Disorders and Schizophrenia for School-Age Children
(K-SADS; parent and child)
Children's Depression Inventory (CDI)
Children's Depression Inventory—Parent(CDI-P)
Children's Depression Rating Scale-Revised (CDRS)
Children's Attributional Style Questionnaire-Revised (CASQ)
Perceived Control Scale (PCS)
Child Health Questionnaire (CHQ; parent and child)
Children's Global Assessment Scale (CGAS)
Pediatric Crohn's Disease Activity Index (PCDAI; for Crohn's disease)
Clinical Score of Kozarek (CSK; for ulcerative colitis)

Estimated Enrollment:	41
Study Start Date:	September 2002
Study Completion Date:	August 2007

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.

Eligibility

Ages Eligible for Study:	11 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Step One
1. Ages 11 to 17 inclusive.
2. Capable of completing CDI
3. English-speaking.
4. Meeting diagnostic criteria for IBD (The date of diagnosis = date of the first diagnostic test confirming IBD)
5. Absence of mental retardation by history
6. 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
1. CDI score equal to or more than 9 AND/OR CDI-P score equal to or more than 9 at T0.
2. Absence of recent suicide attempt (within one month of study enrollment) or depression severity requiring acute psychiatric hospitalization),
3. Age 11-17 years inclusive,
4. Presence of at least one biological parent.

Exclusion Criteria:

Current major depression or dysthymia by 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.
Current pregnancy by history.
Substance abuse 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446238

Locations

United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Children's Hospital of Pittsburgh

Harvard University

Children's Hospital Boston

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Eva Szigethy, MD, PhD	University of Pittsburgh / Children's Hospital of Pittsburgh
Principal Investigator:	David DeMaso, MD	Harvard University / Children's Hospital Boston

More Information

Publications of Results:

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.

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.

Publications indexed to this study:

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):1290-8.

Study ID Numbers:	1 K23 MH64604-01A1
Study First Received:	March 8, 2007
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00446238
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Depression
Physical Illness
Inflammatory Bowel Disease
Cognitive Behavioral Therapy

Study placed in the following topic categories:

Digestive System Diseases
Depression
Gastrointestinal Diseases
Mental Disorders
Mood Disorders

Inflammatory Bowel Diseases
Gastroenteritis
Depressive Disorder
Intestinal Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009