Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The purpose of the current study is to investigate the role of Cognitive Remediation Therapy
      (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia
      Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment
      engagement post-discharge, increased rate of weight gain post-discharge, reduction in symptom
      accommodation, and increased behavioral flexibility in adolescents and parents.
    

Detailed description: 
      Anorexia Nervosa (AN) is a severe psychiatric condition; the hallmark features are low body
      weight and difficulties gaining weight. We are in need of new methods to jump start
      treatment, while targeting relevant processes in individuals with AN.

      Study Design:

      This is a randomized controlled trial looking to address these concerns, with a focus on
      three distinct aims:

        1. To evaluate the feasibility and acceptability (by patients and staff) of CRT in a
           medical hospitalization setting.

        2. Compare the impact of CRT to CRT + Teach the Parent on adolescent treatment engagement
           post-discharge, rate of weight gain post-discharge, and reduction of symptom
           accommodation.

        3. To evaluate cognitive and behavioral flexibility 6 months post-discharge.

      Setting/Participants:

      Participants will be 60 adolescents with AN or subclinical AN (and their parents).
      Adolescents will be hospitalized for treatment of AN and intervention will occur on an
      inpatient basis. Follow-up will be outpatient.

      Study Interventions and Measures:

      The current study will investigate the impact of intensive CRT (one sessions/day) delivered
      during in hospital for medical stabilization. Shortly after admission to hospital,
      adolescents will be randomly assigned to one of the following conditions: Treatment as usual
      (TAU), CRT+Contact Control (known as "Family Fun Time" or FFT) and CRT + Teach the Parent.
      Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study.
      Follow-up will continue for 6 months post-discharge.

      Description of Investigational Intervention:

      CRT is an adjunctive intervention focusing on the development of meta-cognition: Teaching
      individuals to think about how they think. It involves presenting individuals with a variety
      of tasks requiring increasingly complex mental abilities. These include sorting tasks where
      rules change, geometric figures, illusions, reversing sequences of numbers and letters, and
      finding various routes on a map.

      CRT's focus is mainly on process, instead outcome, and has three main goals:

        1. Improve brain function by exercising and increasing connections in the brain

        2. Encourage individuals to think about their thinking style

        3. Encourage individuals and families to spend time away from thinking about the eating
           disorder
    

Intervention name(s): CRT + Teach the Parent; CRT + Contact Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CRT sessions will occur for 45-60 minutes every day (excluding weekends) for 6-8 days while adolescents are in hospital. Adolescents will be given homework and asked to practice tasks each day.; Adolescents will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). Adolescents will be able to choose 2 tasks from a list and be asked to engage in those tasks with their parents.
Other intervention name(s): CRT+ TtP; CRT + Family Fun Time, or CRT + FFT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Cognitive Flexibility; Behavioral Flexibility