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Completed

NCT Number: NCT05017831

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

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescents

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

Inclusion criteria

Parents

  • Age >18
  • Child with a diagnoses of AN
  • Parent or caregiver willing to participate
  • Fluent in English
  • No co-morbid condition that would exclude participation

Exclusion criteria

Adolescents

  • Adolescent outside age range
  • No more than four sessions of prior CRT in any format
  • Pregnant adolescent
  • Presence of: pervasive developmental disability, psychosis, bipolar disorder, substance abuse, autism spectrum disorder, or intellectual disability
  • Presence of: a brain disorder or injury (such as TBI) that could impact the ability to engage in treatment
  • 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.
  • Concurrent psychosocial therapy

Exclusion criteria

Parents

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

Treatment and study plan

Family Based Treatment

Behavioral

Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.

Other names: FBT

Cognitive Remediation Therapy

Behavioral

Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition. CRT is a behavioral treatment that presents tasks to participants in a standardized order within each session. Each task has a number of levels. Participants stay at the same task-based level until mastered. They then move up a level on that task. participants can be at different levels on different tasks within each session. After completion of tasks, participants are asked to reflect on their thought processes in solving the tasks. Standard prompts are used to guide the discussion.

Other names: CRT

Primary outcomes

  1. Change in executive functioning

    Time frame: Baseline, during treatment, end of treatment

    Investigators will use the Delis Kaplan Executive Functioning System (D-KEFS ) Trails Number-Letter Sequencing subtest, a neurocognitive behavioral task, to assess ability to set-shift (a core component of executive functioning). Investigators will compare change in scaled scores from pre, during, and post-treatment across groups. Scaled scores range from 0-19 with higher scores indicating better executive functioning.

  2. Change in response inhibition

    Time frame: Baseline, during treatment, end of treatment

    Investigators will use the Delis Kaplan Executive Functioning System Inhibition subtest, neurocognitive behavioral task, to assess ability to inhibit automatic responses. Investigators will compare change in scaled scores from pre, during, and post-treatment across groups. Scaled scores range from 0-19 with higher scores indicating better response inhibition.

  3. Change in set-shifting

    Time frame: Baseline, during treatment, end of treatment

    Also using the Delis Kaplan Executive Functioning System Inhibition task, investigators will use scores from the D-KEFS Inhibition/Switching subtest to assess ability to switch between alternating rules (a component of set shifting). Investigators will compare change in scaled scores from pre, during, and post-treatment across groups. Scaled scores range from 0-19 with higher scores indicating better set-shifting.

  4. Change in shifting accuracy

    Time frame: Baseline, during treatment, end of treatment

    Investigators will use the Delis Kaplan Executive Functioning System Verbal Fluency subtest, neurocognitive behavioral task, to assess accuracy in shifting categories (a component of executive functioning). Investigators will compare change in scaled scores from pre, during, and post-treatment across groups. Scaled scores range from 0-19 with higher scores indicating better shifting accuracy.

  5. Change in category switching flexibility

    Time frame: Baseline, during treatment, end of treatment

    Investigators will also use the Delis Kaplan Executive Functioning System Verbal Fluency subtest, category switching scores, to assess flexible switching (a component of executive functioning). Investigators will compare change in scaled scores from pre, during, and post-treatment across groups. Scaled scores range from 0-19 with higher scores indicating better switching flexibility.

  6. Change in flexibility

    Time frame: Baseline, during treatment, end of treatment

    Investigators will use the Delis Kaplan Executive Functioning System Sorting subtest, neurocognitive behavioral task, to assess changes in flexibility.Investigators will compare change in scaled scores from pre, during, and post-treatment across groups. Scaled scores range from 0-19 with higher scores indicating better flexibility.

  7. Change in self-reported inhibition control

    Time frame: Baseline, during treatment, end of treatment

    The Behavior Rating Inventory of Executive Functioning is a self and parent-report measure of executive functioning. The measure comprises 10 clinical scales, of which investigators will use the Inhibition subscale to assess self-reported inhibition control (ranged from 0-100, with higher reporting greater set-shifting ability). Investigators will compare change in T scores from pre, during, and post-treatment across groups.

  8. Change in self-reported set-shifting

    Time frame: Baseline, during treatment, end of treatment

    The Behavior Rating Inventory of Executive Functioning is a self and parent-report measure of executive functioning. The measure comprises 10 clinical scales, of which investigators will use the Shifting subscale to assess self-reported set-shifting. Investigators will compare change in T scores (ranged from 0-100, with higher reporting greater set-shifting ability) from pre, during, and post-treatment across groups.

  9. Rate of weight gain

    Time frame: Baseline, during treatment, end of treatment

    Investigators will weigh participants during treatment to compare rate of change (slope) in weight gain from pre, during, and post-treatment across groups. Larger change in weight indicates greater recovery from the eating disorder.

  10. Change in eating disorder symptomology

    Time frame: Baseline, during treatment, end of treatment

    Adolescents will complete the Eating Disorder Examination - Questionnaire (a 28-item self-report measure of eating disorders symptomatology), while parents will complete the Anorectic Behavior Observation Scale (a 30-item collateral report measure of eating and exercise behavior). Investigators will examine changes in these scores from baseline, during, and post-treatment. Scores range from 0-6 with higher scores suggesting more severe eating disorder symptomatology.

  11. Change in behavioral flexibility (amount consumed)

    Time frame: Baseline, during treatment, end of treatment

    Adolescents will complete a buffet meal during which investigators will record the amount of food they consume in grams. This task aims to assess changes in behavioral flexibility by objectively assessing food choice in individuals with an eating disorder. Investigators will examine changes from baseline, during, and at treatment completion. A larger amount of food eaten (in grams) represents greater behavioral flexibility.

  12. Change in behavioral flexibility (eating disorder behaviors)

    Time frame: Baseline, during treatment, end of treatment

    Adolescents will complete a buffet meal during which investigators will record eating behaviors using a novel checklist (a total score of eating disorder behaviors observed). These behaviors include staring, fidgeting, inappropriate napkin use, frequency of food tearing, frequency of dissecting food. Minimum score for this variable is 0, however, there is no maximum frequency. This task aims to assess changes in behavioral flexibility by objectively assessing eating-related behaviors in individuals with an eating disorder, with higher scores suggesting lower behavioral flexibility. Investigators will examine changes from baseline, during, and at treatment completion.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Shifting Perspectives R33 Phase: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 24, 2021
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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