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Treatment of Depressed Adolescents With Physical Illness

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ClinicalTrials.gov Identifier: NCT00446238
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.


  1. This preliminary randomized trial will demonstrate the feasibility of a large-scale research initiative.
  2. 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 or disease Intervention/treatment
Inflammatory Bowel Disease Depression Behavioral: Cognitive Behavioral Therapy Behavioral: Standard of Community Care Treatment

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Depressed Adolescents With Physical Illness
Study Start Date : September 2002
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
CBT enhanced with physical illness narrative, family education, and social skills components.
Behavioral: Cognitive Behavioral Therapy
CBT enhanced with physical illness narrative, family education, and social skills components.
Active Comparator: Standard of Community Care Treatment
Standard of Community Care Treatment
Behavioral: Standard of Community Care Treatment
Treatment as usual for depression and related symptoms provided within the community.

Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Current major depression or dysthymia by Diagnostic and Statistical Manual (DSM)-IV criteria
  2. History or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria.
  3. Mental retardation by history
  4. Antidepressant or stimulant medications within one month of assessment
  5. 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.
  6. Unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons.
  7. Current pregnancy by history.
  8. Substance abuse within one month of enrollment other than nicotine dependence.
  9. 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446238

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
Harvard University
Boston Children’s Hospital
National Institutes of Health (NIH)
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Szigethy, Associate Professor of Psychiatry, Pediatrics, and Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00446238     History of Changes
Other Study ID Numbers: 1K23MH064604-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by Eva Szigethy, University of Pittsburgh:
Physical Illness
Inflammatory Bowel Disease
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Behavioral Symptoms
Gastrointestinal Diseases
Digestive System Diseases