Clinical trial NCT05017831: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-24
Enrollment: 283
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Random assignment to one of two groups.
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Change in executive functioning
timeFrame: Baseline, during treatment, end of treatment
measure: Change in response inhibition
timeFrame: Baseline, during treatment, end of treatment
measure: Change in set-shifting
timeFrame: Baseline, during treatment, end of treatment
measure: Change in shifting accuracy
timeFrame: Baseline, during treatment, end of treatment
measure: Change in category switching flexibility
timeFrame: Baseline, during treatment, end of treatment
measure: Change in flexibility
timeFrame: Baseline, during treatment, end of treatment
measure: Change in self-reported inhibition control
timeFrame: Baseline, during treatment, end of treatment
measure: Change in self-reported set-shifting
timeFrame: Baseline, during treatment, end of treatment
measure: Rate of weight gain
timeFrame: Baseline, during treatment, end of treatment
measure: Change in eating disorder symptomology
timeFrame: Baseline, during treatment, end of treatment
measure: Change in behavioral flexibility (amount consumed)
timeFrame: Baseline, during treatment, end of treatment
measure: Change in behavioral flexibility (eating disorder behaviors)
timeFrame: Baseline, during treatment, end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Catherine Alix Timko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.