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Reducing Depressive Symptoms in Physically Ill Youth

Primary Purpose

Inflammatory Bowel Disease, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Supportive Non-directive Therapy (SNDT)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital-Boston
  • Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Therapy

Supportive Non-Directive Therapy (SNDT)

Arm Description

Primary & Secondary Control Enhancement Training (PASCET)

Supportive Non-Directive Therapy

Outcomes

Primary Outcome Measures

Change from baseline in CDRS at 3 months
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
Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment.

Full Information

First Posted
September 21, 2007
Last Updated
January 3, 2020
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00534911
Brief Title
Reducing Depressive Symptoms in Physically Ill Youth
Official Title
Reducing Depressive Symptoms in Physically Ill Youth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Depression
Keywords
Depression, Physical Illness, Inflammatory Bowel Disease, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Primary & Secondary Control Enhancement Training (PASCET)
Arm Title
Supportive Non-Directive Therapy (SNDT)
Arm Type
Active Comparator
Arm Description
Supportive Non-Directive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Supportive Non-directive Therapy (SNDT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in CDRS at 3 months
Description
Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment.
Time Frame
Month 0, Month 3
Secondary Outcome Measure Information:
Title
Change from baseline in KSADS diagnosis at 3 months
Description
Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment.
Time Frame
Month 0, Month 3
Other Pre-specified Outcome Measures:
Title
Pediatric Crohns Disease Index
Description
Clinician rated instrument of IBD activity which includes symptoms and objective lab results.
Time Frame
Month 0, Month 3
Title
Pediatric Ulcerative Colitis Index
Description
Clinician rated instrument of gastrointestinal symptoms.
Time Frame
Month 0, Month 3
Title
IMPACT 3
Description
Health-related quality life measure. Self report.
Time Frame
Month 0, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Szigethy, MD, PhD
Organizational Affiliation
University of Pittsburgh/ Children's Hospital of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital-Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27035372
Citation
Keerthy D, Youk A, Srinath AI, Malas N, Bujoreanu S, Bousvaros A, Keljo D, DeMaso DR, Szigethy EM. Effect of Psychotherapy on Health Care Utilization in Children With Inflammatory Bowel Disease and Depression. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):658-664. doi: 10.1097/MPG.0000000000001207.
Results Reference
derived
PubMed Identifier
25822010
Citation
Szigethy E, Youk AO, Gonzalez-Heydrich J, Bujoreanu SI, Weisz J, Fairclough D, Ducharme P, Jones N, Lotrich F, Keljo D, Srinath A, Bousvaros A, Kupfer D, DeMaso DR. Effect of 2 psychotherapies on depression and disease activity in pediatric Crohn's disease. Inflamm Bowel Dis. 2015 Jun;21(6):1321-8. doi: 10.1097/MIB.0000000000000358.
Results Reference
derived
PubMed Identifier
25208108
Citation
Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis. 2014 Dec;20(12):2433-49. doi: 10.1097/MIB.0000000000000170.
Results Reference
derived
PubMed Identifier
24954822
Citation
Szigethy E, Bujoreanu SI, Youk AO, Weisz J, Benhayon D, Fairclough D, Ducharme P, Gonzalez-Heydrich J, Keljo D, Srinath A, Bousvaros A, Kirshner M, Newara M, Kupfer D, DeMaso DR. Randomized efficacy trial of two psychotherapies for depression in youth with inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):726-35. doi: 10.1016/j.jaac.2014.04.014. Epub 2014 May 10.
Results Reference
derived

Learn more about this trial

Reducing Depressive Symptoms in Physically Ill Youth

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