Effectiveness of Cognitive Behavioral Therapy in Reducing Depressive Symptoms in Physically Ill Youth

• Children's Depression Rating Scale-Revised (CDRS) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS), parent and child versions [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]

• Children's Depression Rating Scale-Revised (CDRS) [ Time Frame: two weeks ] [ Designated as safety issue: No ]
• Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS; Parent and Child) [ Time Frame: current symptoms, as well as lifetime symptom history ] [ Designated as safety issue: No ]

• Perceived Control Scale [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Coping Strategies Inventory [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Therapist Alliance Scale for Adolescents (TASA), therapist and patient forms [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Screen for Child Anxiety Related Emotional Disorders (SCARED), parent and child versions [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• General Information Sheet (GIS) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Medical Information Sheet [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Brief Symptom Inventory (BSI), parent reporting on self [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: Yes ]
• Children's Depression Inventory (CDI), parent and child forms [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Clinical Global Impression Scale-Improvement (CGI-I) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Children's Global Assessment Scale (CGAS) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Impact-III Questionnaire [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Medical Adherence Measure (MAM) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Pediatric Crohn's Disease Activity Index (PCDAI; for Crohn's disease) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Pediatric Ulcerative Colitis Activity Index (PUCAI) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Abdominal Pain Index (API), child and parent forms [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]
• Laboratory measurement for markers of cytokine-induced inflammation [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
• IBD course, as assessed by using a validated classification system of acute, chronic, and chronic intermittent course [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
• Treatment Credibility Scale [ Time Frame: Measured at Months 3, 9, and 15 ] [ Designated as safety issue: No ]

• Perceived Control Scale [ Time Frame: current ] [ Designated as safety issue: No ]
• Coping Strategies Inventory [ Time Frame: current ] [ Designated as safety issue: No ]
• Therapist Alliance Scale for Adolescents (TASA; therapist, and patient forms) [ Time Frame: current ] [ Designated as safety issue: No ]
• Screen for Child Anxiety Related Emotional Disorders (SCARED, parent and child versions) [ Time Frame: two weeks ] [ Designated as safety issue: No ]
• General Information Sheet (GIS) [ Time Frame: current ] [ Designated as safety issue: No ]
• Medical Information Sheet [ Time Frame: lifetime ] [ Designated as safety issue: No ]
• Brief Symptom Inventory (BSI-parent reporting on self) [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
• Children's Depression Inventory (CDI; Parent and Child forms) [ Time Frame: two weeks ] [ Designated as safety issue: No ]
• Clinical Global Impression Scale- Improvement (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Children's Global Assessment Scale (CGAS) [ Time Frame: current ] [ Designated as safety issue: No ]
• Impact-III Questionnaire [ Time Frame: two weeks ] [ Designated as safety issue: No ]
• Medical Adherence Measure (MAM) [ Time Frame: one week ] [ Designated as safety issue: No ]
• Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: current ] [ Designated as safety issue: No ]
• Pediatric Crohn's Disease Activity Index (PCDAI; for Crohn's disease) [ Time Frame: one week ] [ Designated as safety issue: No ]
• Pediatric Ulcerative Colitis Activity Index (PUCAI) [ Time Frame: two days ] [ Designated as safety issue: No ]
• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: one month ] [ Designated as safety issue: No ]
• Abdominal Pain Index (API; child and parent forms) [ Time Frame: two week ] [ Designated as safety issue: No ]
• Laboratory Measurement for markers of cytokine-induced inflammation [ Time Frame: current ] [ 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: current ] [ Designated as safety issue: No ]
• Treatment Credibility Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

This study will compare the effectiveness of cognitive behavioral therapy with supportive nondirective therapy in reducing emotional distress and improving functioning in youth with inflammatory bowel disease and depression.

Depression is a highly comorbid disorder: people with chronic physical illnesses are more than twice as likely as healthy people to develop symptoms of depression. Specifically, children and adolescents with inflammatory bowel disease (IBD) have higher rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBD, such as steroids, may cause depression. Depression can add to the distress already caused by IBD and can inhibit affected individuals from seeking proper health care for their condition, making treatment of any depressive symptoms in youth with IBD particularly important. Cognitive behavioral therapy (CBT), a form of psychotherapy that teaches more effective ways to think and act in order to cope with illness, may improve both emotional and physical outcomes in youth with IBD. This study will compare the effectiveness of CBT with supportive nondirective therapy (SNDT) in reducing emotional distress and improving functioning in youth with IBD and depression.

Study participation through follow-up will last 15 months. All participants will undergo initial assessments that will include an interview and questionnaires about their psychological and physical functioning and a blood test to assess current IBD severity. Eligible participants will then be assigned randomly to receive 12 weeks of CBT designed for youth with IBD or SNDT. Both groups will attend 12 weekly 45- to 60-minute sessions of their assigned treatments. Participants in the CBT group will learn new skills to cope better with emotions, physical illness, and pain. Specific topics will include problem solving skills, education about depression, goal setting, mood monitoring, increasing enjoyable activities, relaxation methods, and ways to change negative thinking into positive thinking. Participants in the SNDT group will receive social support and quality information about the warning signs and risk factors of depression. Both groups will have three parent sessions provided at the beginning, middle, and end of treatment to improve family understanding and communication about the physical illness and about risks for developing depression. Both groups of youth will also have booster sessions every 6 months during follow-up. Outcomes of emotional and health-related factors will be assessed at Months 1, 2, 3, 9, 15 and 18.

• Depression
• Ulcerative Colitis

• Behavioral: Cognitive behavioral therapy (CBT) for youth with inflammatory bowel disease (IBD)
  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 nondirective 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: CBT
  Participants will receive cognitive behavioral therapy designed for youth with inflammatory bowel disease (IBD).
  Intervention: Behavioral: Cognitive behavioral therapy (CBT) for youth with inflammatory bowel disease (IBD)
• Active Comparator: SNDT
  Participants will receive supportive nondirective therapy.
  Intervention: Behavioral: Supportive nondirective therapy (SNDT)

Inclusion Criteria:

• Children's Depression Inventory (CDI) or Children's Depression Inventory-Parent Version (CDI-P) greater than or equal to 10
• Meets diagnostic criteria for Crohn's disease or ulcerative colitis
• Absence of mental retardation by history
• Has at least one appointment at the gastrointestinal clinic (includes patients followed in these clinics as well as those seeking consultation)

Exclusion Criteria:

• History or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria
• Taking antidepressant medications within 1 month of study entry
• Suicidality with severity of intent requiring immediate psychiatric hospitalization or significant act involving intentional self-harm (e.g., cutting or overdose, resulting in medical attention)
• Unacceptable risk of harm to others, as indicated by homicidal or other violent ideation, intent, or action OR use of illegal weapons
• Pregnant
• Substance abuse other than nicotine dependence within 1 month of study entry
• Current treatment with CBT or failure of previous CBT trial of 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, willing to suspend treatment for 12-week acute treatment phase of study