Clinical trial NCT02883413: Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa
Official title: An Investigation of Cognitive Remediation Therapy as an Inpatient Intervention for Adolescents With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Adolescents
Cognitive Flexibility
Behavioral Flexibility
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: The Hilda & Preston Davis Foundation
First posted: 2016-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

1. Adolescent is between 12-18 years of age and living at home, parent or primary caregiver willing to participate in condition they are randomized into
2. Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype), or sub threshold AN according to Diagnostic and Statistical Manual-5 criteria
3. Consent of all family members who will be participating in treatment
4. Adolescent is not currently receiving outpatient treatment for the eating disorder

Exclusion Criteria:

1. Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, substance dependence, substance abuse, or bi-polar disorder
2. caregiver or adolescent with diagnosis of mental retardation, pervasive developmental disorder, or autism spectrum disorder
3. Adolescent with a diagnosis of feeding or eating concerns not elsewhere classified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns
4. Adolescent with diagnosis of avoidant/restrictive food intake disorder.
5. Adolescent or caregiver with acute suicide risk.
6. Concurrent psychosocial treatment for another condition
7. Adolescent or parent not fluent in English

Primary outcomes:
measure: Change in adolescent treatment engagement via questionnaire
timeFrame: Baseline to 3 months post baseline
Secondary outcomes:
measure: Change in adolescent cognitive flexibility via questionnaire
timeFrame: Baseline to 6 months post baseline
measure: Change in parental symptom accommodation, via questionnaire
timeFrame: Baseline to 3 months post baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: C. Alix Timko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timko CA, Fitzpatrick KK, Goulazian T, Kirby D, Parks E, Morrow L, Scharko AM, Peebles R. Conducting a Pilot Randomized Controlled Trial on a Medical Inpatient Unit Utilizing Cognitive Remediation Therapy for Adolescents with Restrictive Eating Disorders: Protocol Updates and Reflections on Feasibility. J Clin Psychol Med Settings. 2020 Jun;27(2):226-234. doi: 10.1007/s10880-020-09704-w.
citation: Timko CA, Goulazian TJ, Fitzpatrick KK, Rodriguez D. Cognitive remediation therapy (CRT) as a pretreatment intervention for adolescents with anorexia nervosa during medical hospitalization: a pilot randomized controlled trial protocol. Pilot Feasibility Stud. 2018 Jun 25;4:87. doi: 10.1186/s40814-018-0277-5. eCollection 2018.