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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT

Clinicaltrials.gov identifier NCT03928028

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted October 6, 2020

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 parents and affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.

  • Condition or Disease:Anorexia Nervosa
  • Intervention/Treatment: Behavioral: Cognitive Remediation Therapy
    Behavioral: Family Based Treatment
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 54 participants
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Intervention Model Description: Random assignment to one of three groups.
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Shifting Perspectives: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
Arm Intervention/treatment
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.

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.
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.

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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Correct Response Shifting sub test
  • 2. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Category Switching sub test
  • 3. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Description sub test (1 or 2)
  • 4. Change in cognitive flexibility [ Time Frame: 7 months ]
    Delis Kaplan Executive Functioning System (D-KEFS) Trails Number-Letter Sequencing sub test
  • 5. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Inhibition sub test
  • 6. Change in cognitive flexibility [ Time Frame: 7 months ]
    D-KEFS Inhibition/Switching sub test
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts

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

Locations

United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator: Catherine Alix Timko, PhD Children's Hospital of Philadelphia

More Information