Reducing Depressive Symptoms in Physically Ill Youth
Condition: Inflammatory Bowel Disease; Depression
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Depression
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Therapy; Supportive Non-directive Therapy (SNDT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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); 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Physical Illness; Inflammatory Bowel Disease; Cognitive Behavioral Therapy