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

September 21, 2007
March 4, 2014
September 2007
December 2013   (final data collection date for primary outcome measure)
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.
  • Medical Adherence Measure (MAM)
  • Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS; Parent and Child)
  • Children's Depression Inventory (CDI; Parent and Child forms)
  • Children's Depression Rating Scale-Revised (CDRS)
  • Clinical Global Impression Scale- Improvement (CGI-I)
  • Children's Global Assessment Scale (CGAS)
  • Impact-III Questionnaire
  • Brief Illness Perception Questionnaire (BIPQ)
  • Pediatric Crohn's Disease Activity Index (PCDAI; for Crohn's disease)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Abdominal Pain Index (API; child and parent forms)
  • Laboratory Measurement for markers of cytokine-induced inflammation
  • IBD Course will be assessed using a validated classification system of acute, chronic and chronic intermittent course (Greene et al., 1994)
Complete list of historical versions of study NCT00534911 on ClinicalTrials.gov Archive Site
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.
  • Perceived Control Scale
  • Coping Strategies Inventory
  • Therapist Alliance Scale for Adolescents (TASA; therapist, and patient forms)
  • Screen for Child Anxiety Related Emotional Disorders (SCARED, parent and child versions)
  • Child and Adolescent Services Assessment (CASA)
  • General Information Sheet (GIS)
  • Medical history information
  • Treatment Credibility Scale
  • Therapy Procedure Checklist
  • 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.
Not Provided
 
Reducing Depressive Symptoms in Physically Ill Youth
Reducing Depressive Symptoms in Physically Ill Youth

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Inflammatory Bowel Disease
  • Depression
  • 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)

  • 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.
  • Experimental: Cognitive Behavioral Therapy
    Primary & Secondary Control Enhancement Training (PASCET)
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Active Comparator: Supportive Non-Directive Therapy (SNDT)
    Supportive Non-Directive Therapy
    Intervention: Behavioral: Supportive Non-directive Therapy (SNDT)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
9 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00534911
0606136
Yes
Eva Szigethy, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Eva Szigethy, MD, PhD University of Pittsburgh/ Children's Hospital of Pittsburgh
University of Pittsburgh
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP