Reducing Depressive Symptoms in Physically Ill Youth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eva Szigethy, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00534911
First received: September 21, 2007
Last updated: March 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Inflammatory Bowel Disease
Depression
Behavioral: Cognitive Behavioral Therapy
Behavioral: Supportive Non-directive Therapy (SNDT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Depressive Symptoms in Physically Ill Youth

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change from baseline in CDRS at 3 months [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
    Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment.


Secondary Outcome Measures:
  • Change from baseline in KSADS diagnosis at 3 months [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
    Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment.


Other Outcome Measures:
  • Pediatric Crohns Disease Index [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
    Clinician rated instrument of IBD activity which includes symptoms and objective lab results.

  • Pediatric Ulcerative Colitis Index [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
    Clinician rated instrument of gastrointestinal symptoms.

  • IMPACT 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
    Health-related quality life measure. Self report.


Estimated Enrollment: 76
Study Start Date: September 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534911

Locations
United States, Massachusetts
Children's Hospital-Boston
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Eva Szigethy, MD, PhD University of Pittsburgh/ Children's Hospital of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Szigethy, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00534911     History of Changes
Obsolete Identifiers: NCT00596869
Other Study ID Numbers: 0606136
Study First Received: September 21, 2007
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Depression
Physical Illness
Inflammatory Bowel Disease
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Inflammatory Bowel Diseases
Intestinal Diseases
Behavioral Symptoms
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 20, 2014