Cognitive Remediation Therapy for Adolescents With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

An Investigation of Cognitive Remediation Therapy as an Inpatient Intervention for Adolescents With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883413
• Other study ID #: 15-012624
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: November 16, 2017

Study information

• Verified date: February 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. To evaluate the feasibility and acceptability (by patients and staff) of CRT in a medical hospitalization setting.

2. 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.

3. 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:

1. Improve brain function by exercising and increasing connections in the brain

2. Encourage individuals to think about their thinking style

3. Encourage individuals and families to spend time away from thinking about the eating disorder

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Behavioral:
• CRT + Teach the Parent
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.
• CRT + Contact Control
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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	The Hilda & Preston Davis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to 6 months post baseline
Secondary	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.	Baseline to 3 months post baseline