Treatment of Depressed Adolescents With Physical Illness

Depression Clinical Trial

Official title:

Treatment of Depressed Adolescents With Physical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446238
• Other study ID #: 1K23MH064604-01A1
• Status: Completed
• Phase: N/A
• First received: March 8, 2007
• Last updated: May 19, 2014
• Start date: September 2002
• Est. completion date: August 2007

Study information

• Verified date: May 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pittsburgh	Children's Hospital Boston, Children's Hospital of Pittsburgh, Harvard University, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No