Back to resultsShifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT
Primary Purpose
Anorexia Nervosa
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Based Treatment
Cognitive Remediation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
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
- 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
- Concurrent psychosocial therapy
Exclusion Criteria: Parents
- 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
Sites / Locations
- Children's Hospital of PhiladelphiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Family Based Treatment (FBT)
FBT w/ Adolescent-focused Cognitive Remediation Therapy
Arm Description
Families will receive 15 sessions of FBT alone.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05017831
First Posted
August 3, 2021
Last Updated
January 5, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05017831
Brief Title
Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT
Official Title
Shifting Perspectives R33 Phase: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
August 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Random assignment to one of two groups.
Masking
Outcomes Assessor
Masking Description
Any study team member who is assessing for outcomes will not know which participant/family is in which group.
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family Based Treatment (FBT)
Arm Type
Active Comparator
Arm Description
Families will receive 15 sessions of FBT alone.
Arm Title
FBT w/ Adolescent-focused Cognitive Remediation Therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Family Based Treatment
Other Intervention Name(s)
FBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy
Other Intervention Name(s)
CRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in executive functioning
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in response inhibition
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in set-shifting
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in shifting accuracy
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in category switching flexibility
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in flexibility
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in self-reported inhibition control
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in self-reported set-shifting
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Rate of weight gain
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in eating disorder symptomology
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in behavioral flexibility (amount consumed)
Description
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.
Time Frame
Baseline, during treatment, end of treatment
Title
Change in behavioral flexibility (eating disorder behaviors)
Description
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.
Time Frame
Baseline, during treatment, end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
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
Use of anti-psychotic medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Alix Timko, PhD
Phone
267-426-5467
Email
timkoc@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Makara, BS
Phone
267-425-1321
Email
makaraa@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Alix Timko, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Alix Timko, PhD
Phone
267-426-5467
Email
timkoc@chop.edu
First Name & Middle Initial & Last Name & Degree
Amanda Makara, BS
Phone
267-425-1321
Email
makaraa@chop.edu
First Name & Middle Initial & Last Name & Degree
Catherine Alix Timko, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16330590
Citation
Holliday J, Tchanturia K, Landau S, Collier D, Treasure J. Is impaired set-shifting an endophenotype of anorexia nervosa? Am J Psychiatry. 2005 Dec;162(12):2269-75. doi: 10.1176/appi.ajp.162.12.2269.
Results Reference
background
PubMed Identifier
33539993
Citation
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.
Results Reference
background
PubMed Identifier
30626367
Citation
Kucharska K, Kulakowska D, Starzomska M, Rybakowski F, Biernacka K. The improvement in neurocognitive functioning in anorexia nervosa adolescents throughout the integrative model of psychotherapy including cognitive remediation therapy. BMC Psychiatry. 2019 Jan 9;19(1):15. doi: 10.1186/s12888-018-1984-4.
Results Reference
background
PubMed Identifier
29542258
Citation
Harrison A, Stavri P, Ormond L, McEnemy F, Akyol D, Qureshi A, Al-Khairulla H. Cognitive remediation therapy for adolescent inpatients with severe and complex anorexia nervosa: A treatment trial. Eur Eat Disord Rev. 2018 May;26(3):230-240. doi: 10.1002/erv.2584. Epub 2018 Mar 15.
Results Reference
background
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Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT
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