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Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRT + Teach the Parent
CRT + Contact Control
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Adolescents, Cognitive Flexibility, Behavioral Flexibility

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. 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
  3. Consent of all family members who will be participating in treatment
  4. Adolescent is not currently receiving outpatient treatment for the eating disorder

Exclusion Criteria:

  1. Caregiver or adolescent with a co-morbid diagnosis of psychotic disorder, substance dependence, substance abuse, or bi-polar disorder
  2. caregiver or adolescent with diagnosis of mental retardation, pervasive developmental disorder, or autism spectrum disorder
  3. 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
  4. Adolescent with diagnosis of avoidant/restrictive food intake disorder.
  5. Adolescent or caregiver with acute suicide risk.
  6. Concurrent psychosocial treatment for another condition
  7. Adolescent or parent not fluent in English

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

CRT +Teach the Parent

CRT + Family Fun Time

Treatment as Usual (TAU)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in adolescent cognitive flexibility via questionnaire
The Cognitive Flexibility Scale (CFS) is a 12-item self report measure that assesses 3 different components: cognitive flexibility, rigidity and communication flexibility. Scores for each question range from 1-6 (strongly disagree - strongly agree). Scores on cognitive flexibility are positively related to communication flexibility and negatively related to rigidity. Scores on communication flexibility are also negatively related to rigidity.
Change in parental symptom accommodation, via questionnaire
The Accommodation and Enabling Scale for Eating Disorders (AESED) is a 39-item measure that gathers information about the enabling behaviors that family members with a child who has an eating disorder engage in. It contains three subscales: avoidance and modifying routine, meal ritual, and control of the family.

Full Information

First Posted
August 2, 2016
Last Updated
February 5, 2019
Sponsor
Children's Hospital of Philadelphia
Collaborators
The Hilda & Preston Davis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02883413
Brief Title
Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa
Official Title
An Investigation of Cognitive Remediation Therapy as an Inpatient Intervention for Adolescents With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
The Hilda & Preston Davis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Anorexia Nervosa (AN) is a severe psychiatric condition; the hallmark features are low body weight and difficulties gaining weight. We are in need of new methods to jump start treatment, while targeting relevant processes in individuals with AN. Study Design: This is a randomized controlled trial looking to address these concerns, with a focus on three distinct aims: To evaluate the feasibility and acceptability (by patients and staff) of CRT in a medical hospitalization setting. Compare the impact of CRT to CRT + Teach the Parent on adolescent treatment engagement post-discharge, rate of weight gain post-discharge, and reduction of symptom accommodation. To evaluate cognitive and behavioral flexibility 6 months post-discharge. Setting/Participants: Participants will be 60 adolescents with AN or subclinical AN (and their parents). Adolescents will be hospitalized for treatment of AN and intervention will occur on an inpatient basis. Follow-up will be outpatient. Study Interventions and Measures: The current study will investigate the impact of intensive CRT (one sessions/day) delivered during in hospital for medical stabilization. Shortly after admission to hospital, adolescents will be randomly assigned to one of the following conditions: Treatment as usual (TAU), CRT+Contact Control (known as "Family Fun Time" or FFT) and CRT + Teach the Parent. Psychosocial, neurocognitive, and behavioral measures will be collected throughout the study. Follow-up will continue for 6 months post-discharge. Description of Investigational Intervention: CRT is an adjunctive intervention focusing on the development of meta-cognition: Teaching individuals to think about how they think. It involves presenting individuals with a variety of tasks requiring increasingly complex mental abilities. These include sorting tasks where rules change, geometric figures, illusions, reversing sequences of numbers and letters, and finding various routes on a map. CRT's focus is mainly on process, instead outcome, and has three main goals: Improve brain function by exercising and increasing connections in the brain Encourage individuals to think about their thinking style Encourage individuals and families to spend time away from thinking about the eating disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Adolescents, Cognitive Flexibility, Behavioral Flexibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT +Teach the Parent
Arm Type
Experimental
Arm Description
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.
Arm Title
CRT + Family Fun Time
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
Adolescents in this condition will not receive any additional treatment. They will have a standard hospital stay with all normal contact with health professionals.
Intervention Type
Behavioral
Intervention Name(s)
CRT + Teach the Parent
Other Intervention Name(s)
CRT+ TtP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CRT + Contact Control
Other Intervention Name(s)
CRT + Family Fun Time, or CRT + FFT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in adolescent treatment engagement via questionnaire
Description
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.
Time Frame
Baseline to 3 months post baseline
Secondary Outcome Measure Information:
Title
Change in adolescent cognitive flexibility via questionnaire
Description
The Cognitive Flexibility Scale (CFS) is a 12-item self report measure that assesses 3 different components: cognitive flexibility, rigidity and communication flexibility. Scores for each question range from 1-6 (strongly disagree - strongly agree). Scores on cognitive flexibility are positively related to communication flexibility and negatively related to rigidity. Scores on communication flexibility are also negatively related to rigidity.
Time Frame
Baseline to 6 months post baseline
Title
Change in parental symptom accommodation, via questionnaire
Description
The Accommodation and Enabling Scale for Eating Disorders (AESED) is a 39-item measure that gathers information about the enabling behaviors that family members with a child who has an eating disorder engage in. It contains three subscales: avoidance and modifying routine, meal ritual, and control of the family.
Time Frame
Baseline to 3 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Alix Timko, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32052249
Citation
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.
Results Reference
derived
PubMed Identifier
29983992
Citation
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.
Results Reference
derived

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Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa

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