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Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT

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ClinicalTrials.gov Identifier: NCT03928028
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
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 parents and affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: Cognitive Remediation Therapy Behavioral: Family Based Treatment Not Applicable

Detailed Description:
This application seeks support for a phased project. In the initial (R61) 2-year phase, the investigators will establish that Cognitive Remediation Therapy (CRT) can increase set-shifting in parents of and/or adolescents with Anorexia Nervosa (AN). The second aim is to determine the appropriate dose needed to achieve positive change in set-shifting. Attaining this milestone would trigger support for three additional years (R33) to confirm target engagement and appropriate dose. The investigators will also evaluate whether or not adding CRT to Family Based Treatment (FBT) will improve outcome compared to FBT alone. Set-shifting (a type of executive functioning often referred to as cognitive flexibility) inefficiencies are hypothesized to be an endophenotype of AN and are, therefore, heritable. Cognitive flexibility can be impacted negatively by situational factors such as malnutrition, stress, and anxiety. It is likely that both adolescents (who are malnourished) and parents (who are under stress) experience significant state-based reduction in their cognitive flexibility during AN and its treatment. While cognitive flexibility can be increased through CRT, there is a significant gap in the knowledge about how to apply CRT to the treatment of adolescent AN, specifically concerning the most appropriate target for CRT: parents or adolescents? The majority of research on CRT with adolescents with AN are pilot and feasibility studies and target set-shifting in adolescents, not parents. The investigators hypothesize that targeting parents may be more impactful for adolescent outcome. First, the investigators must determine if an increase set-shifting via CRT is possible. In the initial R61 phase, the investigators propose to recruit and randomly assign 54 families who have a child with AN to FBT, FBT with parent-focused CRT, or FBT with adolescent-focused CRT. Target engagement will be assessed via neuro-psychological assessment and self-report of cognitive and behavioral flexibility. If the investigators meet these proposed milestones in the R61 phase, they will proceed to the R33 phase. It is possible that one (N = 72 families) or both (N = 93 families) CRT conditions will be examined in the R33 phase. The investigators will confirm the findings from the R61 phase (target engagement and dose of CRT). The investigators will also examine adolescent outcome in FBT alone versus FBT+(parent or adolescent) CRT. They will gather preliminary data on putative moderators and/or mediators across both phases in order to inform results. This phased R61/R33 application is innovative in that it is the first to adapt CRT to parents only. Evidence supporting FBT+CRT to increase set-shifting in parents/adolescents will inform future efforts to leverage understanding of (heritable) neurobiology of AN in adolescents to improve outcome. Further, if CRT for parents significantly improves set-shifting, the investigators can focus efforts on how best to augment current treatments, support parents, and increase positive outcomes for the adolescent and reduce relapse. Even negative results would inform understanding of set-shifting inefficiencies as an endophenotype in AN, its measurement, and usefulness as a target in treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Random assignment to one of three groups.
Masking: Single (Outcomes Assessor)
Masking Description: Any study team member who is assessing for outcomes will not which participant/family is in which group.
Primary Purpose: Treatment
Official Title: Shifting Perspectives: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021

Arm Intervention/treatment
Active Comparator: Family Based Treatment (FBT)
Families will receive 15 sessions of FBT alone.
Behavioral: Family Based Treatment
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 Name: FBT

Experimental: FBT w/ Parent-focused Cognitive Remediation Therapy
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Behavioral: Cognitive Remediation Therapy
Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Other Name: CRT

Behavioral: Family Based Treatment
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 Name: FBT

Experimental: FBT w/Adolescent-focused Cognitive Remediation Therapy
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Behavioral: Cognitive Remediation Therapy
Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Other Name: CRT

Behavioral: Family Based Treatment
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 Name: FBT




Primary Outcome Measures :
  1. Change in cognitive flexibility [ Time Frame: 7 months ]
    Delis Kaplan Executive Functioning System (D-KEFS) Trails Number-Letter Sequencing sub test

  2. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Inhibition sub test

  3. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Inhibition/Switching sub test

  4. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Correct Response Shifting sub test

  5. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Category Switching sub test

  6. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Description sub test (1 or 2)

  7. Change in cognitive flexibility [ Time Frame: 7 months ]
    Shift in sub-scale of the Behavior Rating Inventory of Executive Functioning (BRIEF)

  8. Dose of CRT [ Time Frame: 7 months ]
    Number of sessions necessary (session = subject receive dose of CRT) in order to change cognitive flexibility



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 live with the adolescent

Inclusion Criteria:Parents

  1. Age >18
  2. Child with a diagnoses of AN
  3. Both parents willing to participate
  4. Fluent in English
  5. No co-morbid condition that would exclude participation

Exclusion Criteria: Adolescent

  1. Adolescent outside age range
  2. Adolescent adopted
  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
  7. Concurrent psychosocial therapy

Exclusion Criteria: Parents

  1. Presence of: pervasive developmental disability, psychosis, 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
  3. Use of anti-psychotic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928028


Contacts
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Contact: Catherine Alix Timko, PhD 267-426-5467 timkoc@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Catherine A Timko, PhD    267-426-5467    timkoc@email.chop.edu   
Principal Investigator: Catherine A Timko, PhD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Catherine Alix Timko, PhD Children's Hospital of Philadelphia

Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03928028     History of Changes
Other Study ID Numbers: 19-016064
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders