Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT

NCT03928028 | Completed Results DMC

• 2 other identifiers: 19-0160641R61MH119262-01
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  6 months of treatment

Study Arms (3)

Family Based Treatment (FBT)

ACTIVE COMPARATOR

Families will receive 15 sessions of FBT alone.

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.

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.

Behavioral: Cognitive Remediation Therapy; Behavioral: Family Based Treatment

Interventions

Cognitive Remediation Therapy BEHAVIORAL

Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.

Also known as: CRT

FBT w/ Parent-focused Cognitive Remediation Therapy; FBT w/Adolescent-focused Cognitive Remediation Therapy

Family Based Treatment BEHAVIORAL

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.

Also known as: FBT

FBT w/ Parent-focused Cognitive Remediation Therapy; FBT w/Adolescent-focused Cognitive Remediation Therapy; Family Based Treatment (FBT)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

• 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.

  PMID: 16330590 BACKGROUND

• 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.

  PMID: 24347025 BACKGROUND

• 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.

  PMID: 17261218 BACKGROUND

• 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.

  PMID: 20398910 BACKGROUND

• 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.

  PMID: 26563611 BACKGROUND

• 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.

  PMID: 30626367 BACKGROUND

• 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.

  PMID: 29542258 BACKGROUND

• 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.

  PMID: 35780511 DERIVED

• 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.

  PMID: 33539993 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: C. Alix Timko
• Organization: Children's Hospital of Philadlephia

timkoc@chop.edu

2674265467

Study Officials

• Catherine Alix Timko, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Any study team member who is assessing for outcomes will not which participant/family is in which group.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment to one of three groups.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 25, 2019
• Study Start: April 1, 2019
• Primary Completion: June 24, 2021
• Study Completion: June 24, 2021
• Last Updated: January 20, 2023
• Results First Posted: January 20, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)