Anorexia NervosaNCT03928028

Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT

A study testing Cognitive Remediation Therapy and Family Based Treatment in people with Anorexia Nervosa, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and older
Conditions the study is for: Anorexia Nervosa
What is being tested?: Cognitive Remediation Therapy and Family Based Treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 177 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2019to 24 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

Biological parent or primary caregiver willing to engage in treatment and who live with the adolescent
Age >18
Child with a diagnoses of AN
Both parents willing to participate
Fluent in English
No co-morbid condition that would exclude participation

Who cannot join

Adolescent outside age range
Adolescent adopted
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

Show all 10Show fewer

Concurrent psychosocial therapy
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Shifting Perspectives: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)

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.

Read the 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.

Conditions: Anorexia Nervosa
Being tested: Cognitive Remediation Therapy, Family Based Treatment
Medical subject headings: Anorexia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Remediation TherapyBehavioural
Also called CRT
Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based TreatmentBehavioural
Also called FBT
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.

Study groups in NCT03928028
Study group	Role	What they receive
Family Based Treatment (FBT)	Active comparator	Families will receive 15 sessions of FBT alone. Receives: Behavioral: Family Based Treatment
FBT w/ Parent-focused Cognitive Remediation Therapy	Experimental	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. Receives: Behavioral: Cognitive Remediation Therapy; Behavioral: Family Based Treatment
FBT w/Adolescent-focused Cognitive Remediation Therapy	Experimental	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. Receives: Behavioral: Cognitive Remediation Therapy; Behavioral: Family Based Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Trail Making Test assesses flexibility in thinking. We use Condition 4 (Number-Letter Switching) to assess flexibility.
Measured: 6 months of treatment
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Inhibition refers to the ability to inhibit a well learned or salient task in order to do something different; thus, it is related to flexibility. The D-KEFS Color-Word Interference Test (Condition 3: Inhibition) to assess ability to inhibit automatic responses.
Measured: 6 months of treatment
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Color Word Interference (Condition 4: Inhibition/Switching) assess the ability to switch between alternating rules (a component of set shifting).
Measured: 6 months of treatment
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. The Switching Correct score is used to assess flexibility.
Measured: 6 months of treatment
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. Switching Accuracy assesses the number of times an accurate switch between categories occurs.
Measured: 6 months of treatment
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The Sorting Test assesses flexibility in thinking and problem solving.
Measured: 6 months of treatment
Change in Self-Reported Shifting - BRIEF
The Behavior Rating Inventory of Executive Functioning (BRIEF) is an ecologically valid clinical tool for measuring executive functioning across several domains in youth 5 to 18 years of age; the self-report version (BRIEF-2) was administered to adolescents. It has a comparable adult self-report version (BRIEF-A) normed for ages 18-90. Both versions of the BRIEF are normed by age and sex on a T-scale (mean = 50, SD = 10), and scores are considered clinically elevated if they are 65 or higher. Both have a number of clinical scales and indices. Lower scores indicate greater strengths in each area. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants, thus, we expect a reduction in scores for those in the CRT conditions. The BRIEF was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The BRIEF Shift assesses behavioral flexibility.
Measured: 6 months of treatment
Dose of CRT
Number of sessions necessary in order to change cognitive flexibility. This is the number of sessions needed for change to occur in cognitive flexibility. It is only calculated for the participants who received CRT and who had a significant change in flexibility above what was observed in FBT.
Measured: 6 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201924 Jun 2021

First posted25 Apr 2019
Study start1 Apr 2019
Primary completion24 Jun 2021
Study completion24 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Anorexia NervosaStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: Random assignment to one of three groups.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03928028
Sponsor's protocol ID: 19-016064
Other IDs: 1R61MH119262-01
Status last verified: Dec 2022
First submitted: 8 Apr 2019
Last updated: 20 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 16330590
Lang K, Stahl D, Espie J, Treasure J, Tchanturia K. Set shifting in children and adolescents with anorexia nervosa: an exploratory systematic review and meta-analysis. Int J Eat Disord. 2014 May;47(4):394-9. doi: 10.1002/eat.22235. Epub 2013 Dec 18.
PubMed 24347025
Roberts ME, Tchanturia K, Stahl D, Southgate L, Treasure J. A systematic review and meta-analysis of set-shifting ability in eating disorders. Psychol Med. 2007 Aug;37(8):1075-84. doi: 10.1017/S0033291707009877. Epub 2007 Jan 30.
PubMed 17261218
Roberts ME, Tchanturia K, Treasure JL. Exploring the neurocognitive signature of poor set-shifting in anorexia and bulimia nervosa. J Psychiatr Res. 2010 Oct;44(14):964-70. doi: 10.1016/j.jpsychires.2010.03.001. Epub 2010 Apr 15.
PubMed 20398910
Lang K, Treasure J, Tchanturia K. Is inefficient cognitive processing in anorexia nervosa a familial trait? A neuropsychological pilot study of mothers of offspring with a diagnosis of anorexia nervosa. World J Biol Psychiatry. 2016 Jun;17(4):258-65. doi: 10.3109/15622975.2015.1112035. Epub 2015 Dec 1.
PubMed 26563611
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.
PubMed 30626367
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.
PubMed 29542258
Susanin A, Cooper M, Makara A, Kuschner ES, Timko CA. Autistic characteristics in youth with anorexia nervosa before and after treatment. Eur Eat Disord Rev. 2022 Sep;30(5):664-670. doi: 10.1002/erv.2937. Epub 2022 Jul 3.
PubMed 35780511
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.
PubMed 33539993

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Shifting Perspectives: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT)
ClinicalTrials.gov ID: NCT03928028
Acronym / sponsor ID: 19-016064
Conditions: Anorexia Nervosa
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Apr 2019 (actual)
Primary completion: 24 Jun 2021 (actual)
Study completion: 24 Jun 2021 (actual)
First posted: 25 Apr 2019 (actual)
Results: Posted 20 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Random assignment to one of three groups.

Arm	Type	Receives
Family Based Treatment (FBT)	Active comparator	Behavioral: Family Based TreatmentFamilies will receive 15 sessions of FBT alone.
FBT w/ Parent-focused Cognitive Remediation Therapy	Experimental	Behavioral: Cognitive Remediation Therapy, Behavioral: Family Based TreatmentFamily 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.
FBT w/Adolescent-focused Cognitive Remediation Therapy	Experimental	Behavioral: Cognitive Remediation Therapy, Behavioral: Family Based TreatmentFamily 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.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (10 listed)

Adolescent outside age range
Adolescent adopted
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Remediation TherapyAlso: CRTCognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.	Behavioural	FBT w/ Parent-focused Cognitive Remediation Therapy, FBT w/Adolescent-focused Cognitive Remediation Therapy
Family Based TreatmentAlso: FBTFamily 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.	Behavioural	FBT w/ Parent-focused Cognitive Remediation Therapy, FBT w/Adolescent-focused Cognitive Remediation Therapy, Family Based Treatment (FBT)

Primary outcome

Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Time frame: 6 months of treatment
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Trail Making Test assesses flexibility in thinking. We use Condition 4 (Number-Letter Switching) to assess flexibility.
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Time frame: 6 months of treatment
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Inhibition refers to the ability to inhibit a well learned or salient task in order to do something different; thus, it is related to flexibility. The D-KEFS Color-Word Interference Test (Condition 3: Inhibition) to assess ability to inhibit automatic responses.
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Time frame: 6 months of treatment
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Color Word Interference (Condition 4: Inhibition/Switching) assess the ability to switch between alternating rules (a component of set shifting).
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Time frame: 6 months of treatment
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. The Switching Correct score is used to assess flexibility.
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Time frame: 6 months of treatment
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. Switching Accuracy assesses the number of times an accurate switch between categories occurs.
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Time frame: 6 months of treatment
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The Sorting Test assesses flexibility in thinking and problem solving.
Change in Self-Reported Shifting - BRIEF
Time frame: 6 months of treatment
The Behavior Rating Inventory of Executive Functioning (BRIEF) is an ecologically valid clinical tool for measuring executive functioning across several domains in youth 5 to 18 years of age; the self-report version (BRIEF-2) was administered to adolescents. It has a comparable adult self-report version (BRIEF-A) normed for ages 18-90. Both versions of the BRIEF are normed by age and sex on a T-scale (mean = 50, SD = 10), and scores are considered clinically elevated if they are 65 or higher. Both have a number of clinical scales and indices. Lower scores indicate greater strengths in each area. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants, thus, we expect a reduction in scores for those in the CRT conditions. The BRIEF was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The BRIEF Shift assesses behavioral flexibility.
Dose of CRT
Time frame: 6 months of treatment
Number of sessions necessary in order to change cognitive flexibility. This is the number of sessions needed for change to occur in cognitive flexibility. It is only calculated for the participants who received CRT and who had a significant change in flexibility above what was observed in FBT.

Results and safety

Results posted to the registry on 20 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family Based Treatment (FBT)	63	42
FBT w/ Parent-focused Cognitive Remediation Therapy	57	48
FBT w/Adolescent-focused Cognitive Remediation Therapy	57	51

Primary outcome: Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS

Time frame: 6 months of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Family Based Treatment (FBT) n = 63	FBT w/ Parent-focused Cognitive Remediation Therapy n = 57	FBT w/Adolescent-focused Cognitive Remediation Therapy n = 57
Mother- T1	11.89 (.875)	10.94 (2.331)	11.47 (1.663)
Mother - T3	11.14 (2.742)	11.86 (2.107)	12.00 (1.663)
Mother - T4	12.18 (.874)	12.70 (.675)	12.27 (1.191)
1Mother - T5	12.75 (1.165)	13.11 (.782)	13.25 (1.708)
Father - T1	11.14 (2.265)	11.06 (1.819)	11.35 (2.060)
Father - T3	11.92 (1.382)	12.57 (1.342)	12.23 (1.092)
Father - T4	11.82 (2.136)	13.10 (1.101)	12.09 (1.640)
Father - T5	12.14 (1.069)	12.80 (.919)	13.00 (1.549)

Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .507, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .017, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/Adolescent-focused Cognitive Remediation Therapy: p = .139, generalized estimating equation

Population analysed: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

Primary outcome: Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS

Time frame: 6 months of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Family Based Treatment (FBT) n = 63	FBT w/ Parent-focused Cognitive Remediation Therapy n = 57	FBT w/Adolescent-focused Cognitive Remediation Therapy n = 57
Mother -T1	11.95 (2.291)	11.84 (1.608)	12.21 (2.175)
Mother - T3	12.72 (1.565)	12.06 (1.237)	12.94 (2.014)
Mother - T4	13.06 (1.436)	12.25 (1.528)	13.12 (1.996)
Mother - T5	13.67 (1.923)	12.93 (1.668)	13.33 (1.718)
Father - T1	11.14 (2.689)	12.11 (1.941)	11.63 (2.52)
Father - T3	11.94 (1.798)	13.06 (1.436)	12.50 (2.176)
Father - T4	12.43 (1.742)	12.75 (2.840)	13.00 (1.581)
Father - T5	12.55 (1.753)	13.67 (1.291)	12.80 (1.740)

Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .389, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .447, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/Adolescent-focused Cognitive Remediation Therapy: p <.001, generalized estimating equation

Population analysed: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

Primary outcome: Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS

Time frame: 6 months of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Family Based Treatment (FBT) n = 63	FBT w/ Parent-focused Cognitive Remediation Therapy n = 57	FBT w/Adolescent-focused Cognitive Remediation Therapy n = 57
Mother - T1	11.71 (1.101)	11.05 (1.615)	11.95 (2.041)
Mother - T3	12.78 (1.215)	12.50 (1.633)	12.78 (1.700)
Mother - T4	12.75 (1.844)	12.63 (1.586)	13.35 (1.801)
Mother - T5	13.83 (1.467)	13.13 (1.356)	13.40 (1.549)
Father - T1	11.67 (2.106)	12.05 (1.433)	11.37 (2.929)
Father - T3	12.56 (1.504)	13.13 (1.088)	12.56 (1.790)
Father - T4	12.86 (2.070)	13.19 (1.515)	12.94 (1.391)
Father - T5	13.09 (1.446)	13.73 (1.033)	13.00 (1.414)

Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .778, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .297, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/Adolescent-focused Cognitive Remediation Therapy: p = .062, generalized estimating equation

Population analysed: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

Primary outcome: Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS

Time frame: 6 months of treatment. Mean (Standard Deviation). Unit: score on a scale

Measure	Family Based Treatment (FBT) n = 63	FBT w/ Parent-focused Cognitive Remediation Therapy n = 57	FBT w/Adolescent-focused Cognitive Remediation Therapy n = 57
Mother - T1	12.10 (3.478)	11.95 (2.718)	11.74 (4.483)
Mother - T3	12.47 (3.717)	12.44 (3.444)	11.18 (3.695)
Mother - T4	13.00 (4.195)	12.44 (3.464)	13.29 (4.089)
Mother - T5	12.42 (3.288)	13.53 (2.446)	13.47 (2.949)
Father - T1	11.81 (3.628)	10.68 (3.973)	10.63 (3.218)
Father - T3	11.68 (3.528)	11.50 (3.759)	11.33 (4.102)
Father - T4	12.71 (4.286)	11.88 (3.757)	12.00 (3.386)
Father - T5	12.45 (2.911)	11.43 (3.694)	11.73 (4.399)

Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .069, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/ Parent-focused Cognitive Remediation Therapy: p = .323, generalized estimating equation
Family Based Treatment (FBT) vs FBT w/Adolescent-focused Cognitive Remediation Therapy: p = .225, generalized estimating equation

Population analysed: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.

Adverse events

Time frame: 6 months (from baseline intake to end of treatment). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Family Based Treatment (FBT)	0 of 63 (0%)	0 of 63 (0%)	0 of 63
FBT w/ Parent-focused Cognitive Remediation Therapy	0 of 57 (0%)	1 of 57 (1.8%)	0 of 57
FBT w/Adolescent-focused Cognitive Remediation Therapy	0 of 57 (0%)	0 of 57 (0%)	0 of 57

Limitations and caveats (from the sponsor): The onset of the pandemic required that much data collection occur remotely, therefore, there is substantial missing data for Card Sort and Trail Making Test of the DKEFS. There were covid related delays in data scoring and analysis. For each condition, we have a group of mothers, fathers, and youth. Each group is analyzed separately in each condition. We compared youth in FBT to youth in CRTA and parents in FBT to parents in CRTP.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16330590Holliday 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.
Background: PubMed 24347025Lang K, Stahl D, Espie J, Treasure J, Tchanturia K. Set shifting in children and adolescents with anorexia nervosa: an exploratory systematic review and meta-analysis. Int J Eat Disord. 2014 May;47(4):394-9. doi: 10.1002/eat.22235. Epub 2013 Dec 18.
Background: PubMed 17261218Roberts ME, Tchanturia K, Stahl D, Southgate L, Treasure J. A systematic review and meta-analysis of set-shifting ability in eating disorders. Psychol Med. 2007 Aug;37(8):1075-84. doi: 10.1017/S0033291707009877. Epub 2007 Jan 30.
Background: PubMed 20398910Roberts ME, Tchanturia K, Treasure JL. Exploring the neurocognitive signature of poor set-shifting in anorexia and bulimia nervosa. J Psychiatr Res. 2010 Oct;44(14):964-70. doi: 10.1016/j.jpsychires.2010.03.001. Epub 2010 Apr 15.
Background: PubMed 26563611Lang K, Treasure J, Tchanturia K. Is inefficient cognitive processing in anorexia nervosa a familial trait? A neuropsychological pilot study of mothers of offspring with a diagnosis of anorexia nervosa. World J Biol Psychiatry. 2016 Jun;17(4):258-65. doi: 10.3109/15622975.2015.1112035. Epub 2015 Dec 1.
Background: PubMed 30626367Kucharska 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.
Background: PubMed 29542258Harrison 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.
Derived from this study: PubMed 35780511Susanin A, Cooper M, Makara A, Kuschner ES, Timko CA. Autistic characteristics in youth with anorexia nervosa before and after treatment. Eur Eat Disord Rev. 2022 Sep;30(5):664-670. doi: 10.1002/erv.2937. Epub 2022 Jul 3.
Derived from this study: PubMed 33539993Timko 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catherine Alix Timko, PhD principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Remediation Therapy and Family Based Treatment in people with Anorexia Nervosa, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS (time frame: 6 months of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03928028, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.