Treatment of Depressed Adolescents With Physical Illness
Condition: Inflammatory Bowel Disease; Depression
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Depression
Study type: Interventional

Summary: 
      The purpose of this study is a randomized trial of cognitive-behavioral intervention (CBI)
      for eligible adolescents who have Inflammatory Bowel Disease and subsyndromal depressive
      symptoms, but who did not meet diagnostic criteria for major depressive disorder at the time
      of randomization into the study.

      Hypotheses

        1. This preliminary randomized trial will demonstrate the feasibility of a large-scale
           research initiative.

        2. Subjects will experience no adverse events, and the CBI group will demonstrate improved
           negative cognitions, depressive symptomatology, and functioning at the post-intervention
           and 6- through 12-month follow-ups.
    

Detailed description: 
      This study is a pilot study, which will serve to determine the feasibility of a larger
      research initiative. The broader research is aimed at the prevention of depressive disorders
      in adolescents with inflammatory bowel disease (IBD) who have risk factors for depression,
      using a psychotherapeutic intervention. The intervention is based on a cognitive-behavioral
      approach to treating depression, the Primary and Secondary Control Enhancement Training
      (PASCET), that has been modified and enhanced with physical illness narrative, social skills,
      and family components (PASCET-Physical Illness), to make it more appropriate for physically
      ill adolescents at risk for major depression. The cognitive-behavioral intervention (CBI)
      draws on an etiological hypothesis that depression in adolescents with chronic physical
      illness results from cumulative risk factors such as distorted cognitive processes, negative
      physical illness experience, poor social functioning, and ineffective family interactions.
      Thus, the development of depression may be prevented by teaching adolescents effective
      strategies to 1) cope using cognitive-behavioral skills, 2) enhance social functioning, 3)
      develop a more cohesive illness narrative, and 4) improve family communication skills.

      The study is a randomized trial of the CBI for adolescents with IBD and depressive symptoms,
      using the provision of psychoeducational materials as the attention control group. This study
      is a pilot study designed to show feasibility of assessing and treating youth with
      sub-syndromal depressive symptoms and IBD using a randomized clinical design at Children's
      Hospital Pittsburgh (CHP) as a preliminary step for designing a two-site randomized trial
      Children's Hospital of Pittsburgh and Children's Hospital Boston powered to test preventive
      effects of this CBI in this medically co-morbid population.

      In this study, eligible adolescents who are at risk for developing depression due to having a
      chronic physical illness (IBD) as well as having subsyndromal depressive symptoms but who do
      not currently meet diagnostic criteria for major depressive disorder according to a
      diagnostic interview will be randomly assigned either to receive CBI or psychoeducation.
    

Intervention name(s): Cognitive Behavioral Therapy; Standard of Community Care Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT enhanced with physical illness narrative, family education, and social skills components.; Treatment as usual for depression and related symptoms provided within the community.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Physical Illness; Inflammatory Bowel Disease; Cognitive Behavioral Therapy