Reducing Depressive Symptoms in Physically Ill Youth
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|ClinicalTrials.gov Identifier: NCT00534911|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : January 7, 2020
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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.
- Individuals who receive CBT will show more improvement than individuals who receive SNDT.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Depression||Behavioral: Cognitive Behavioral Therapy Behavioral: Supportive Non-directive Therapy (SNDT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reducing Depressive Symptoms in Physically Ill Youth|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2019|
Experimental: Cognitive Behavioral Therapy
Primary & Secondary Control Enhancement Training (PASCET)
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)
Active Comparator: Supportive Non-Directive Therapy (SNDT)
Supportive Non-Directive Therapy
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.
- Change from baseline in CDRS at 3 months [ Time Frame: Month 0, Month 3 ]Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment.
- Change from baseline in KSADS diagnosis at 3 months [ Time Frame: Month 0, Month 3 ]Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment.
- Pediatric Crohns Disease Index [ Time Frame: Month 0, Month 3 ]Clinician rated instrument of IBD activity which includes symptoms and objective lab results.
- Pediatric Ulcerative Colitis Index [ Time Frame: Month 0, Month 3 ]Clinician rated instrument of gastrointestinal symptoms.
- IMPACT 3 [ Time Frame: Month 0, Month 3 ]Health-related quality life measure. Self report.
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|Ages Eligible for Study:||9 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- CDI or CDI-P greater than or equal to 10 at Step 1.
- ages between 9-17 inclusive
- having CD
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534911
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Eva Szigethy, MD, PhD||University of Pittsburgh/ Children's Hospital of Pittsburgh|
|Responsible Party:||Eva Szigethy, Principal Investigator, University of Pittsburgh|
|Other Study ID Numbers:||
|First Posted:||September 26, 2007 Key Record Dates|
|Last Update Posted:||January 7, 2020|
|Last Verified:||January 2020|
Inflammatory Bowel Disease
Cognitive Behavioral Therapy
Inflammatory Bowel Diseases
Digestive System Diseases