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Shifting Perspectives: 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: Family Based Treatment
Behavioral: Cognitive Remediation Therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03928028
19-016064
1R61MH119262-01 (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 parents and affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.

Full description

This application seeks support for a phased project. In the initial (R61) 2-year phase, the investigators will establish that Cognitive Remediation Therapy (CRT) can increase set-shifting in parents of and/or adolescents with Anorexia Nervosa (AN). The second aim is to determine the appropriate dose needed to achieve positive change in set-shifting. Attaining this milestone would trigger support for three additional years (R33) to confirm target engagement and appropriate dose. The investigators will also evaluate whether or not adding CRT to Family Based Treatment (FBT) will improve outcome compared to FBT alone. Set-shifting (a type of executive functioning often referred to as cognitive flexibility) inefficiencies are hypothesized to be an endophenotype of AN and are, therefore, heritable. Cognitive flexibility can be impacted negatively by situational factors such as malnutrition, stress, and anxiety. It is likely that both adolescents (who are malnourished) and parents (who are under stress) experience significant state-based reduction in their cognitive flexibility during AN and its treatment. While cognitive flexibility can be increased through CRT, there is a significant gap in the knowledge about how to apply CRT to the treatment of adolescent AN, specifically concerning the most appropriate target for CRT: parents or adolescents? The majority of research on CRT with adolescents with AN are pilot and feasibility studies and target set-shifting in adolescents, not parents. The investigators hypothesize that targeting parents may be more impactful for adolescent outcome. First, the investigators must determine if an increase set-shifting via CRT is possible. In the initial R61 phase, the investigators propose to recruit and randomly assign 54 families who have a child with AN to FBT, FBT with parent-focused CRT, or FBT with adolescent-focused CRT. Target engagement will be assessed via neuro-psychological assessment and self-report of cognitive and behavioral flexibility. If the investigators meet these proposed milestones in the R61 phase, they will proceed to the R33 phase. It is possible that one (N = 72 families) or both (N = 93 families) CRT conditions will be examined in the R33 phase. The investigators will confirm the findings from the R61 phase (target engagement and dose of CRT). The investigators will also examine adolescent outcome in FBT alone versus FBT+(parent or adolescent) CRT. They will gather preliminary data on putative moderators and/or mediators across both phases in order to inform results. This phased R61/R33 application is innovative in that it is the first to adapt CRT to parents only. Evidence supporting FBT+CRT to increase set-shifting in parents/adolescents will inform future efforts to leverage understanding of (heritable) neurobiology of AN in adolescents to improve outcome. Further, if CRT for parents significantly improves set-shifting, the investigators can focus efforts on how best to augment current treatments, support parents, and increase positive outcomes for the adolescent and reduce relapse. Even negative results would inform understanding of set-shifting inefficiencies as an endophenotype in AN, its measurement, and usefulness as a target in treatment.

Enrollment

177 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 live with the adolescent

Inclusion Criteria:Parents

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

Exclusion Criteria: Adolescent

  1. Adolescent outside age range
  2. Adolescent adopted
  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
  7. Concurrent psychosocial therapy

Exclusion Criteria: Parents

  1. Presence of: pervasive developmental disability, psychosis, 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
  3. Use of anti-psychotic medication

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

177 participants in 3 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/ Parent-focused Cognitive Remediation Therapy
Experimental group
Description:
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Treatment:
Behavioral: Cognitive Remediation Therapy
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 adolescent focused CRT followed by Family Based Treatment over six months.
Treatment:
Behavioral: Cognitive Remediation Therapy
Behavioral: Family Based Treatment

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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