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

NCT05017831 | Completed DMC

• 3 other identifiers: 21-0190795R61MH119262-02R33MH119262
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (12)

• Change in executive functioning

  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.

  Baseline, during treatment, end of treatment

• Change in response inhibition

  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.

  Baseline, during treatment, end of treatment

• Change in set-shifting

  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.

  Baseline, during treatment, end of treatment

• Change in shifting accuracy

  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.

  Baseline, during treatment, end of treatment

• Change in category switching flexibility

  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.

  Baseline, during treatment, end of treatment

• Change in flexibility

  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.

  Baseline, during treatment, end of treatment

• Change in self-reported inhibition control

  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.

  Baseline, during treatment, end of treatment

• Change in self-reported set-shifting

  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.

  Baseline, during treatment, end of treatment

• Rate of weight gain

  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.

  Baseline, during treatment, end of treatment

• Change in eating disorder symptomology

  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.

  Baseline, during treatment, end of treatment

• Change in behavioral flexibility (amount consumed)

  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.

  Baseline, during treatment, end of treatment

• Change in behavioral flexibility (eating disorder behaviors)

  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.

  Baseline, during treatment, end of treatment

Study Arms (2)

Family Based Treatment (FBT)

ACTIVE COMPARATOR

Families will receive 15 sessions of FBT alone.

Behavioral: Family Based Treatment

FBT w/ Adolescent-focused Cognitive Remediation Therapy

EXPERIMENTAL

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.

Behavioral: Family Based Treatment; Behavioral: Cognitive Remediation Therapy

Interventions

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.

Also known as: FBT

FBT w/ Adolescent-focused Cognitive Remediation Therapy; Family Based Treatment (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.

Also known as: CRT

FBT w/ Adolescent-focused Cognitive Remediation Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (5)

• Timko CA, Bhattacharya A, Fitzpatrick KK, Howe H, Rodriguez D, Mears C, Heckert K, Ubel PA, Ehrenreich-May J, Peebles R. The shifting perspectives study protocol: Cognitive remediation therapy as an adjunctive treatment to family based treatment for adolescents with anorexia nervosa. Contemp Clin Trials. 2021 Apr;103:106313. doi: 10.1016/j.cct.2021.106313. Epub 2021 Feb 1.

  PMID: 33539993 BACKGROUND

• Orloff NC, McGinley K, Lenz K, Mack AS, Timko CA. Adaptations of cognitive remediation therapy for adolescents with anorexia nervosa for delivery via telehealth. Int J Eat Disord. 2023 Jan;56(1):72-79. doi: 10.1002/eat.23850. Epub 2022 Nov 19.

  PMID: 36401578 BACKGROUND

• Cooper M, Mears C, Heckert K, Orloff N, Peebles R, Timko CA. The buffet challenge: a behavioral assessment of eating behavior in adolescents with an eating disorder. J Eat Disord. 2024 Jan 18;12(1):8. doi: 10.1186/s40337-024-00968-3.

  PMID: 38238787 BACKGROUND

• Miller ML, Timko CA, Hormes JM. Factor structure of the Eating Disorder Flexibility Index in U.S. nonclinical collegiate and clinical adolescent samples. Eat Behav. 2024 Jan;52:101847. doi: 10.1016/j.eatbeh.2024.101847. Epub 2024 Jan 27.

  PMID: 38301405 BACKGROUND

• Timko CA, Schnabel J, Orloff NC. The importance of improving cognitive flexibility in adolescents with anorexia nervosa: The case for cognitive remediation therapy. Int J Eat Disord. 2024 May;57(5):1109-1118. doi: 10.1002/eat.24164. Epub 2024 Feb 9.

  PMID: 38333943 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Catherine Alix Timko, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Any study team member who is assessing for outcomes will not know which participant/family is in which group.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment to one of two groups.

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 24, 2021
• Study Start: November 5, 2021
• Primary Completion: November 21, 2024
• Study Completion: May 21, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)