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

Not Applicable

Active, not recruiting

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: Family Based Treatment; Behavioral: Cognitive Remediation Therapy

• Registration Number: NCT05017831
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Study Start: 2021-11-05
• Primary Completion: 2024-11-21
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Family Based Treatment (FBT)	Family Based Treatment	Families will receive 15 sessions of FBT alone.
FBT w/ Adolescent-focused Cognitive Remediation Therapy	Family Based Treatment	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.
FBT w/ Adolescent-focused Cognitive Remediation Therapy	Cognitive Remediation Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in executive functioning	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.
Change in response inhibition	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.
Change in shifting accuracy	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.
Change in category switching flexibility	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.
Change in flexibility	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.
Change in set-shifting	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.
Change in self-reported set-shifting	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.
Rate of weight gain	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.
Change in eating disorder symptomology	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.
Change in behavioral flexibility (eating disorder behaviors)	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.
Change in self-reported inhibition control	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.
Change in behavioral flexibility (amount consumed)	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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States