Reducing Depressive Symptoms in Physically Ill Youth

• Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS; Parent and Child) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Children's Depression Inventory (CDI; Parent and Child forms) [ Time Frame: MOb, M1, M2, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Children's Depression Rating Scale-Revised (CDRS) [ Time Frame: M0b, M3, M9, M15, M18 ] [ Designated as safety issue: No ]
• Clinical Global Impression Scale- Improvement (CGI-I) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Children's Global Assessment Scale (CGAS) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Impact-III Questionnaire [ Time Frame: MOb, M1, M2, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Medical Adherence Measure (MAM) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Pediatric Crohn's Disease Activity Index (PCDAI; for Crohn's disease) [ Time Frame: MOa, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Abdominal Pain Index (API; child and parent forms) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Laboratory Measurement for markers of cytokine-induced inflammation [ Time Frame: MOa, M3, M9, M15, M18 ] [ Designated as safety issue: No ]
• IBD Course will be assessed using a validated classification system of acute, chronic and chronic intermittent course (Greene et al., 1994) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]

• 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
• Medical Adherence Measure (MAM)
• 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)

• Perceived Control Scale [ Time Frame: MOb, M1, M2, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Coping Strategies Inventory [ Time Frame: MOb, M1, M2, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Therapist Alliance Scale for Adolescents (TASA; therapist, and patient forms) [ Time Frame: M3 ] [ Designated as safety issue: No ]
• Screen for Child Anxiety Related Emotional Disorders (SCARED, parent and child versions) [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Child and Adolescent Services Assessment (CASA) [ Time Frame: M3, M6, M9, M15 ] [ Designated as safety issue: No ]
• General Information Form (GIF) [ Time Frame: M0a ] [ Designated as safety issue: No ]
• Medical history information [ Time Frame: MOb, M3, M6, M9, M15, M18 ] [ Designated as safety issue: No ]
• Treatment Credibility Scale [ Time Frame: M3 ] [ Designated as safety issue: No ]
• Therapy Procedure Checklist [ Time Frame: M3 ] [ Designated as safety issue: No ]

• 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

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.

Hypotheses

• Individuals who receive CBT will have significantly decreased severity of symptoms of depression, improved functioning more generally, improved medication adherence, illness perception and health-related quality of life compared to the SNDT group
• The CBT group will have significantly decreased negative cognitive processing and improved coping strategies compared to the SNDT group
• (Exploratory) Changes in depressive severity will be mediated by changes in cognitive processes and coping strategies on the CBT group
• (Exploratory) Corticosteroid treatment, older age, lower SES, degree of psychiatric comorbidity, and male gender will be moderators of the effect of the intervention on depressive symptoms

• Inflammatory Bowel Disease
• Subsyndromal Depression

• Behavioral: Primary and Secondary Coping Enhancement Training (PASCET)
  a manual-based cognitive-behavioral therapy
• Behavioral: Supportive Non-directive Therapy (SNDT)
  A non-directive, process-oriented talking therapy

• Active Comparator: 1
  PASCET
  Intervention: Behavioral: Primary and Secondary Coping Enhancement Training (PASCET)
• Placebo Comparator: 2
  SNDT
  Intervention: Behavioral: Supportive Non-directive Therapy (SNDT)

Inclusion Criteria:

Step 1:

• age 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