NCT02883413

Brief Summary

The purpose of the current study is to investigate the role of Cognitive Remediation Therapy (CRT) as a pre-treatment intervention for adolescents who are hospitalized for Anorexia Nervosa (AN). The primary aims are to determine if CRT can result in greater treatment engagement post-discharge, increased rate of weight gain post-discharge, reduction in symptom accommodation, and increased behavioral flexibility in adolescents and parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2017

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

August 2, 2016

Last Update Submit

February 5, 2019

Conditions

Anorexia Nervosa

Keywords

AdolescentsCognitive FlexibilityBehavioral Flexibility

Outcome Measures

Primary Outcomes (1)

  • Change in adolescent treatment engagement via questionnaire

    The Motivational Stages of Change for Adolescents Recovering from an Eating Disorder (MSCARED) is a questionnaire designed to assess readiness to change among individuals with eating disorders. It is administered via interview, discussing motivation, actions that qualify for making changes, and asking what stage of change the patient is in. The patient then checks off those actions they are doing that contribute to their recovery from a provided checklist.

    Baseline to 3 months post baseline

Secondary Outcomes (2)

  • Change in adolescent cognitive flexibility via questionnaire

    Baseline to 6 months post baseline

  • Change in parental symptom accommodation, via questionnaire

    Baseline to 3 months post baseline

Study Arms (3)

CRT +Teach the Parent

EXPERIMENTAL

The Teach the Parent (TtP) addition to CRT is designed to increase parental understanding of their adolescents' thinking styles. We hypothesize that by doing so, parents will be more likely to challenge eating disorder behaviors and be less likely to accommodate behavioral symptoms of the eating disorder (e.g., make something low-fat for dinner because it will be easier). In this arm, adolescents will explain what they learned during CRT and walk their parents though at least 4 tasks during each TtP session. Parents and child will not be permitted to speak about the eating disorder during these sessions. TtP sessions will occur 3-4 times during hospitalization and will be guided by the adolescent.

Behavioral: CRT + Teach the Parent

CRT + Family Fun Time

ACTIVE COMPARATOR

In order to assess for any non-specific effects of spending non-eating disorder driven time with family, adolescents in the CRT+ Contact Control condition will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). We refer to this condition as CRT + Family Fun Time (CRT+FFT). Adolescents will be asked to complete a series of fun tasks (some standardized, some are choice driven) with their parents. During these sessions, they will not be permitted to discuss CRT or the eating disorder.

Behavioral: CRT + Contact Control

Treatment as Usual (TAU)

NO INTERVENTION

Adolescents in this condition will not receive any additional treatment. They will have a standard hospital stay with all normal contact with health professionals.

Interventions

CRT + Teach the ParentBEHAVIORAL

CRT sessions will occur for 45-60 minutes every day (excluding weekends) for 6-8 days while adolescents are in hospital. Adolescents will be given homework and asked to practice tasks each day.

Also known as: CRT+ TtP
CRT +Teach the Parent
CRT + Contact ControlBEHAVIORAL

Adolescents will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). Adolescents will be able to choose 2 tasks from a list and be asked to engage in those tasks with their parents.

Also known as: CRT + Family Fun Time, or CRT + FFT
CRT + Family Fun Time

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent is between 12-18 years of age and living at home, parent or primary caregiver willing to participate in condition they are randomized into
  • Adolescent meets diagnostic criteria of anorexia nervosa (either restricting or binge/purge subtype), or sub threshold AN according to Diagnostic and Statistical Manual-5 criteria
  • Consent of all family members who will be participating in treatment
  • Adolescent is not currently receiving outpatient treatment for the eating disorder

You may not qualify if:

  • Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, substance dependence, substance abuse, or bi-polar disorder
  • caregiver or adolescent with diagnosis of mental retardation, pervasive developmental disorder, or autism spectrum disorder
  • Adolescent with a diagnosis of feeding or eating concerns not elsewhere classified with the primary symptoms of bingeing and purging, binging without compensatory behaviors or spitting food or with restricting patterns
  • Adolescent with diagnosis of avoidant/restrictive food intake disorder.
  • Adolescent or caregiver with acute suicide risk.
  • Concurrent psychosocial treatment for another condition
  • Adolescent or parent not fluent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Timko CA, Fitzpatrick KK, Goulazian T, Kirby D, Parks E, Morrow L, Scharko AM, Peebles R. Conducting a Pilot Randomized Controlled Trial on a Medical Inpatient Unit Utilizing Cognitive Remediation Therapy for Adolescents with Restrictive Eating Disorders: Protocol Updates and Reflections on Feasibility. J Clin Psychol Med Settings. 2020 Jun;27(2):226-234. doi: 10.1007/s10880-020-09704-w.

    PMID: 32052249DERIVED

  • Timko CA, Goulazian TJ, Fitzpatrick KK, Rodriguez D. Cognitive remediation therapy (CRT) as a pretreatment intervention for adolescents with anorexia nervosa during medical hospitalization: a pilot randomized controlled trial protocol. Pilot Feasibility Stud. 2018 Jun 25;4:87. doi: 10.1186/s40814-018-0277-5. eCollection 2018.

    PMID: 29983992DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • C. Alix Timko, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 30, 2016

Study Start

August 1, 2016

Primary Completion

November 16, 2017

Study Completion

November 16, 2017

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)