Reducing Depressive Symptoms in Physically Ill Youth



Status:Active, not recruiting
Conditions:Depression, Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology
Healthy:No
Age Range:9 - 17
Updated:12/8/2018
Start Date:September 2007
End Date:December 2019

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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.

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.
Furthermore, the medications used to treat IBR, such as steroids, may induce depression. 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 and depression. This study will also be the first to assess
the effect of CBT on IBD-related factors such as disease severity, medication adherence, and
physical-health related quality of life.

Participants will be carefully evaluated for depression and those who have clinically
significant depression will be randomly assigned to either CBT designed for youth with IBD or
supportive therapy sessions. Youth in the CBT group will learn new ways of thinking and
acting to reduce symptoms of depression focused on the reconstruction of negative or hopeless
physical illness narratives. Parents in the CBT group will participate in three family
sessions designed to improve family understanding and communication about the physical
illness and about risks for developing depression. Children in the supportive therapy
condition will receive social support and information about IBD and depression similar to
what they would likely receive from social workers in their pediatric medical clinic. Because
emotional difficulties such as the experience of depressive symptoms have been linked with
the severity and course of IBD symptoms, this information may enable parents to better help
their child cope with his/her physical illness. In addition, participants in both groups may
experience reduced depression and improved quality of life.

It is predicted that those in the CBT group will benefit by learning effective strategies for
coping with IBD and depression, enhancing their social skills, and improving family
communication skills while those in the supportive therapy group will benefit by receiving
social support and useful information. The proposed study will help determine which
psychosocial approach is of greater benefit for depressed youth with IBD and provide a model
for integrating behavioral treatment to decrease both emotional and IBD-related suffering
into the comprehensive medical care for IBD in the pediatric population.

Aim 1(primary) Are there differences between the two types of therapy in terms of improving
depression.

Aim 2 (secondary) Are there differences between the two types of therapy in terms of
improving IBD activity, quality of life, and medication adherence? Aim 3) (secondary) Are
there differences between the two types of therapy in terms of improving sleep and pain? Aim
4) (exploratory) Are anxiety, steroid use, and gender moderators of treatment outcome.

Inclusion Criteria:

Step 1:

- ages 9 to 17 inclusive

- capable of completing CDI

- meeting diagnostic criteria for CD (the date of diagnosis = date of the first
diagnostic test confirming CD)

- absence of mental retardation by history

- having at least one appointment at the GI clinic (this will include patients followed
in these clinics as well as those seeking consultation)

Step 2:

- CDI or CDI-P greater than or equal to 10 at Step 1.

- ages between 9-17 inclusive

- having CD

Exclusion Criteria:

- history or current episode of bipolar disorder, eating disorder, or psychotic disorder
by DSM-IV criteria

- mental retardation by history

- antidepressant 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 by history within one month of enrollment other than nicotine
dependence

- current treatment with 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 using a manual

- if currently receiving other psychotherapy modalities willingness to suspend treatment
for 12-week acute treatment phase of study
We found this trial at
2
sites
Boston, Massachusetts 02115
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Boston, MA
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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