Abstract
BackgroundAnorexia nervosa (AN) is a severe psychiatric condition characterized by low body weight, fear of weight gain/becoming fat and/or behavior that interferes with weight gain, and body disturbance. Though there have been recent advances in the treatment of AN, there continues to be an urgent need to increase treatment options. Cognitive remediation therapy (CRT) has been successfully used as an adjunctive treatment for individuals with AN. In this study, we pilot the use of CRT plus an innovative parent involvement component as a pre-treatment intervention on a medical unit. We hypothesize that adding CRT with parent involvement to a standard hospital stay is feasible, acceptable by patients and staff, and may improve treatment outcomes post-hospitalization.Methods/designThis is a pilot randomized controlled trial with three arms. Participants are adolescents aged 12–18 with AN; 60 participants will be included. They are randomized into one of three groups: treatment as usual (TAU, standard care at Children’s Hospital of Philadelphia), CRT + contact control (known as “Family Fun Time”), and CRT + Teach the Parent. Intervention will occur on an inpatient basis. Follow-up will be outpatient and will continue until 6 months post-discharge. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study, and group differences will be evaluated at 4 weeks, 3 months, and 6 months post-discharge. The study will take place at The Children’s Hospital of Philadelphia.DiscussionThis pilot randomized controlled trial will inform feasibility of the integration of a pre-treatment intervention into a medical hospital stay for AN. We will assess recruitment procedures, treatment administration, and participant retention. Finally, a comprehensive assessment battery will be evaluated. Secondary goals are to conduct a preliminary evaluation of whether or not CRT with parent involvement increases rate of weight gain and treatment engagement and decreases parental accommodation of symptoms post-discharge. If successful, this pilot study will inform a larger controlled trial fully powered to examine the secondary goals.Trial registrationClinicalTrials.gov Identifier NCT02883413
Highlights
Introduction to Cognitive remediation therapy (CRT) and to eitherFamily 1 Fun Time or Teach the ParentsReview of the purpose of CRT and informing family of which condition they have been randomized to
Cognitive remediation therapy and contact control (Family Fun Time, FFT) In order to assess for any non-specific effects of spending non-eating disorder driven time with family, adolescents in the CRT + contact control condition will be asked to spend 3–4 sessions with their parents engaging in fun activities
The current study is a pilot and feasibility study that examines the implementation of CRT on a medical unit in a large children’s hospital
Summary
The current study is a pilot and feasibility study that examines the implementation of CRT on a medical unit in a large children’s hospital The description of this protocol followed SPIRIT guidelines [53, 54]. CRT + TTP is compared to treatment as usual and a CRT + contact control group (CRT + FFT) As this is a pilot and feasibility study, we have specified the outcomes we would use in a larger, randomized clinical trial. Not of primary interest, we are collecting additional data on cognitive flexibility and will track changes that occur in participants’ level of flexibility over time This pilot study will inform a larger trial that will significantly add to the literature on the use of CRT with adolescents with AN. Author details 1Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA. 2Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children’s Hospital of Philadelphia, Philadelphia, PA 19104, USA. 3Psychiatry and Behavioral Sciences, Stanford Children’s Hospital, Stanford, CA, USA. 4Department of Urban Public Health and Nutrition, La Salle University, Philadelphia, PA 19141, USA
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