Cognitive remediation therapy (CRT) as a pretreatment intervention for adolescents with anorexia nervosa during medical hospitalization: a pilot randomized controlled trial protocol

C Alix Timko, Tiffanie J Goulazian, Kathleen Kara Fitzpatrick, Daniel Rodriguez, C Alix Timko, Tiffanie J Goulazian, Kathleen Kara Fitzpatrick, Daniel Rodriguez

Abstract

Background: Anorexia 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/design: This 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.

Discussion: This 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 registration: ClinicalTrials.gov Identifier NCT02883413.

Keywords: Adolescents; Anorexia nervosa; Cognitive remediation therapy; Mixed methods modeling; RCT.

Conflict of interest statement

The Institutional Review Board (IRB) of Children’s Hospital of Philadelphia reviewed and approved all study materials, consent forms, and protocols (IRB: 15-012624).The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flowchart/timetable for data collection

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