Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Depressed Adolescents With Physical Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00446238
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : May 20, 2014
Sponsor:
Collaborators:
Harvard University
Boston Children’s Hospital
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eva Szigethy, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 8, 2007
First Posted Date  ICMJE March 12, 2007
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE September 2002
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2007)
  • 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)
Change History Complete list of historical versions of study NCT00446238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Depressed Adolescents With Physical Illness
Official Title  ICMJE Treatment of Depressed Adolescents With Physical Illness
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.

Hypotheses

  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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammatory Bowel Disease
  • Depression
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy
    CBT enhanced with physical illness narrative, family education, and social skills components.
  • Behavioral: Standard of Community Care Treatment
    Treatment as usual for depression and related symptoms provided within the community.
Study Arms  ICMJE
  • Experimental: Cognitive Behavioral Therapy
    CBT enhanced with physical illness narrative, family education, and social skills components.
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Active Comparator: Standard of Community Care Treatment
    Standard of Community Care Treatment
    Intervention: Behavioral: Standard of Community Care Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2007)
41
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00446238
Other Study ID Numbers  ICMJE 1K23MH064604-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eva Szigethy, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • Harvard University
  • Boston Children’s Hospital
  • National Institutes of Health (NIH)
Investigators  ICMJE
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
PRS Account University of Pittsburgh
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP