Reducing Depressive Symptoms in Physically Ill Youth

NCT00534911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-01-07

No results posted yet for this study

Summary

Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.

Hypothesis

\- Individuals who receive CBT will show more improvement than individuals who receive SNDT.

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy

Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up. Other Name: Primary and secondary coping enhancement training (PASCET)

BEHAVIORAL

Supportive Non-directive Therapy (SNDT)

SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Eva Szigethy, MD, PhD · University of Pittsburgh/ Children's Hospital of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2013-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534911 on ClinicalTrials.gov