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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00596869 |
This study will compare the effectiveness of cognitive behavioral therapy with supportive nondirective therapy in reducing emotional distress and improving functioning in youth with inflammatory bowel disease and depression.
Condition | Intervention |
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Depression Ulcerative Colitis |
Behavioral: Cognitive behavioral therapy (CBT) for youth with inflammatory bowel disease (IBD) Behavioral: Supportive nondirective therapy (SNDT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Reducing Depressive Symptoms in Physically Ill Youth |
Estimated Enrollment: | 475 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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CBT: Experimental
Participants will receive cognitive behavioral therapy designed for youth with inflammatory bowel disease (IBD).
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Behavioral: Cognitive behavioral therapy (CBT) for youth with inflammatory bowel disease (IBD)
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.
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SNDT: Active Comparator
Participants will receive supportive nondirective therapy.
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Behavioral: Supportive nondirective 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.
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Depression is a highly comorbid disorder: people with chronic physical illnesses are more than twice as likely as healthy people to develop symptoms of depression. Specifically, children and adolescents with inflammatory bowel disease (IBD) have higher rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBD, such as steroids, may cause depression. Depression can add to the distress already caused by IBD and can inhibit affected individuals from seeking proper health care for their condition, making treatment of any depressive symptoms in youth with IBD particularly important. Cognitive behavioral therapy (CBT), a form of psychotherapy that teaches more effective ways to think and act in order to cope with illness, may improve both emotional and physical outcomes in youth with IBD. This study will compare the effectiveness of CBT with supportive nondirective therapy (SNDT) in reducing emotional distress and improving functioning in youth with IBD and depression.
Study participation through follow-up will last 15 months. All participants will undergo initial assessments that will include an interview and questionnaires about their psychological and physical functioning and a blood test to assess current IBD severity. Eligible participants will then be assigned randomly to receive 12 weeks of CBT designed for youth with IBD or SNDT. Both groups will attend 12 weekly 45- to 60-minute sessions of their assigned treatments. Participants in the CBT group will learn new skills to cope better with emotions, physical illness, and pain. Specific topics will include problem solving skills, education about depression, goal setting, mood monitoring, increasing enjoyable activities, relaxation methods, and ways to change negative thinking into positive thinking. Participants in the SNDT group will receive social support and quality information about the warning signs and risk factors of depression. Both groups will have three parent sessions provided at the beginning, middle, and end of treatment to improve family understanding and communication about the physical illness and about risks for developing depression. Both groups of youth will also have booster sessions every 6 months during follow-up. Outcomes of emotional and health-related factors will be assessed at Months 1, 2, 3, 9, 15 and 18.
Ages Eligible for Study: | 9 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eva M. Szigethy, MD, PhD | 412-692-8147 | szigethye@upmc.edu |
United States, Massachusetts | |
Children's Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: David DeMaso, MD 617-355-6724 David.demaso@childrens.harvard.edu | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Eva M. Szigethy, MD, PhD 412-692-8147 szigethye@upmc.edu |
Principal Investigator: | Eva M. Szigethy, MD, PhD | University of Pittsburgh |
Principal Investigator: | David Demaso, MD | Children's Hospital Boston |
Responsible Party: | University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh ( Dr. Eva M. Szigethy ) |
Study ID Numbers: | R01 MH077770, DAHBR 96-BHC, PRO07070128 |
Study First Received: | January 8, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00596869 |
Health Authority: | United States: Federal Government |
Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease |
Depression Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases |
Depressive Disorder Behavioral Symptoms Digestive System Diseases Crohn Disease Gastroenteritis Colitis |
Pathologic Processes |