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Treatment of Depressed Adolescents With Physical Illness

Primary Purpose

Inflammatory Bowel Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Standard of Community Care Treatment
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital Boston
  • Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy

Standard of Community Care Treatment

Arm Description

CBT enhanced with physical illness narrative, family education, and social skills components.

Standard of Community Care Treatment

Outcomes

Primary Outcome Measures

Change from Baseline in CDI at 14 weeks
Change in Childhood Depression Inventory (CDI) scores from week 0 to study endpoint, week 14

Secondary Outcome Measures

Full Information

First Posted
March 8, 2007
Last Updated
May 19, 2014
Sponsor
University of Pittsburgh
Collaborators
Harvard University, Boston Children's Hospital, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00446238
Brief Title
Treatment of Depressed Adolescents With Physical Illness
Official Title
Treatment of Depressed Adolescents With Physical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Harvard University, Boston Children's Hospital, National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Depression
Keywords
Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
CBT enhanced with physical illness narrative, family education, and social skills components.
Arm Title
Standard of Community Care Treatment
Arm Type
Active Comparator
Arm Description
Standard of Community Care Treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
CBT enhanced with physical illness narrative, family education, and social skills components.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Community Care Treatment
Intervention Description
Treatment as usual for depression and related symptoms provided within the community.
Primary Outcome Measure Information:
Title
Change from Baseline in CDI at 14 weeks
Description
Change in Childhood Depression Inventory (CDI) scores from week 0 to study endpoint, week 14
Time Frame
Week 0, Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Szigethy, MD, PhD
Organizational Affiliation
University of Pittsburgh / Children's Hospital of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David DeMaso, MD
Organizational Affiliation
Harvard University / Children's Hospital Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16601643
Citation
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.
Results Reference
result
PubMed Identifier
15564816
Citation
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.
Results Reference
result
PubMed Identifier
17885570
Citation
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.
Results Reference
derived

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Treatment of Depressed Adolescents With Physical Illness

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