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Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status

Completed

Conditions

Anorexia Nervosa

Treatments

Behavioral: Cognitive Remediation Therapy
Behavioral: Family Based Treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05017831
21-019079
5R61MH119262-02 (U.S. NIH Grant/Contract)
R33MH119262 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Anorexia Nervosa is a serious life-threatening illness with a typical age of onset in adolescence; if not effectively treated, it has the potential to significantly impact adolescent development and quality of life. Research on executive functioning in anorexia nervosa indicates that it may be a viable target for intervention that could improve outcome. The current project focuses on determining whether or not the investigators can improve set-shifting in affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.

Full description

This is the second phase (R33) of a two-phased project exploring the effect of adding Cognitive Remediation Therapy (CRT) to traditional Family Based Treatment (FBT) for adolescents with Anorexia Nervosa (AN) and their families. This phase (R33) follows a prior 2-year study (R61) which examined the impact of CRT on set-shifting abilities (a type of executive functioning often referred to as cognitive flexibility). This second phase aims to replicate findings from the first study as well as examine whether the addition of CRT to traditional FBT will impact treatment outcomes (e.g., eating disorder symptoms, weight outcomes). CRT is an adjunctive treatment approach where adolescents learn different ways of thinking and problem solving to become more flexible thinkers. The investigators will recruit and randomly assign 96 families of youth with AN to either an FBT group or FBT with adolescent-focused CRT group. Parents and adolescents will complete questionnaires and assessments to evaluate outcomes and predictors of outcome. Evidence supporting FBT+CRT to increase set-shifting in adolescents will inform future efforts to leverage understanding of neurobiology of AN in adolescents to improve outcome. Results will also inform how best to augment current treatments, support parents, and increase positive outcomes for adolescents with AN, and reduce relapse.

Enrollment

283 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Adolescents

  1. Age 12-18
  2. Currently meets Diagnostic and Statistical Manual-5 criteria for Anorexia Nervosa
  3. Medically stable for outpatient treatment
  4. Fluent in English
  5. No co-morbid condition that would exclude participation
  6. Medical clearance from primary care physician and permission to speak to Primary Care Physician about clinical issues
  7. Biological parent or primary caregiver willing to engage in treatment and who lives with the adolescent

Inclusion Criteria: Parents

  1. Age >18
  2. Child with a diagnoses of AN
  3. Parent or caregiver willing to participate
  4. Fluent in English
  5. No co-morbid condition that would exclude participation

Exclusion Criteria: Adolescents

  1. Adolescent outside age range
  2. No more than four sessions of prior CRT in any format
  3. Pregnant adolescent
  4. Presence of: pervasive developmental disability, psychosis, bipolar disorder, substance abuse, autism spectrum disorder, or intellectual disability
  5. Presence of: a brain disorder or injury (such as TBI) that could impact the ability to engage in treatment
  6. Use of anti-psychotic medication during first 15 FBT sessions. Use of this medication is permitted in the optional 12 FBT sessions in the 6-month follow-up period of this study. This medication can affect cognitive abilities, which may interact with assessments that measure cognitive flexibility. However, we do not measure cognitive flexibility in the 6-month follow-up period when the 12 additional FBT sessions can take place.
  7. Concurrent psychosocial therapy

Exclusion Criteria: Parents

  1. Presence of: pervasive developmental disability, psychosis, uncontrolled bipolar disorder, substance abuse, autism spectrum disorder, or intellectual disability.
  2. Presence of: a brain disorder or injury (such as TBI) that could impact the ability to engage in treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

283 participants in 2 patient groups

Family Based Treatment (FBT)
Active Comparator group
Description:
Families will receive 15 sessions of FBT alone.
Treatment:
Behavioral: Family Based Treatment
FBT w/ Adolescent-focused Cognitive Remediation Therapy
Experimental group
Description:
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of FBT over six months. The first 9 sessions of FBT will be preceded by adolescent-focused CRT.
Treatment:
Behavioral: Family Based Treatment
Behavioral: Cognitive Remediation Therapy

Trial contacts and locations

1

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Central trial contact

Catherine Alix Timko, PhD; Samantha L Turner, PhD

Data sourced from clinicaltrials.gov

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