Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT
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ClinicalTrials.gov Identifier: NCT03928028 |
Recruitment Status :
Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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Anorexia Nervosa | Behavioral: Cognitive Remediation Therapy Behavioral: Family Based Treatment | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention Model Description: | Random assignment to one of three groups. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Any study team member who is assessing for outcomes will not which participant/family is in which group. |
Primary Purpose: | Treatment |
Official Title: | Shifting Perspectives: Enhancing Outcomes in Adolescent Anorexia Nervosa With Cognitive Remediation Therapy (CRT) |
Actual Study Start Date : | August 1, 2019 |
Estimated Primary Completion Date : | March 1, 2021 |
Estimated Study Completion Date : | June 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Family Based Treatment (FBT)
Families will receive 15 sessions of FBT alone.
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Behavioral: Family Based Treatment
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.
Other Name: FBT |
Experimental: FBT w/ Parent-focused Cognitive Remediation Therapy
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.
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Behavioral: Cognitive Remediation Therapy
Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Other Name: CRT Behavioral: Family Based Treatment 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.
Other Name: FBT |
Experimental: FBT w/Adolescent-focused Cognitive Remediation Therapy
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.
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Behavioral: Cognitive Remediation Therapy
Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Other Name: CRT Behavioral: Family Based Treatment 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.
Other Name: FBT |
- Change in cognitive flexibility [ Time Frame: 7 months ]Delis Kaplan Executive Functioning System (D-KEFS) Trails Number-Letter Sequencing sub test
- Change in cognitive flexibility [ Time Frame: 7 months ]D-KEFS Inhibition sub test
- Change in cognitive flexibility [ Time Frame: 7 months ]D-KEFS Inhibition/Switching sub test
- Change in cognitive flexibility [ Time Frame: 7 months ]D-KEFS Correct Response Shifting sub test
- Change in cognitive flexibility [ Time Frame: 7 months ]D-KEFS Category Switching sub test
- Change in cognitive flexibility [ Time Frame: 7 months ]D-KEFS Description sub test (1 or 2)
- Change in cognitive flexibility [ Time Frame: 7 months ]Shift in sub-scale of the Behavior Rating Inventory of Executive Functioning (BRIEF)
- Dose of CRT [ Time Frame: 7 months ]Number of sessions necessary (session = subject receive dose of CRT) in order to change cognitive flexibility

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Adolescents
- 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
Inclusion Criteria:Parents
- Age >18
- Child with a diagnoses of AN
- Both parents willing to participate
- Fluent in English
- No co-morbid condition that would exclude participation
Exclusion Criteria: Adolescent
- 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
Exclusion Criteria: Parents
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928028
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Catherine Alix Timko, PhD | Children's Hospital of Philadelphia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT03928028 |
Other Study ID Numbers: |
19-016064 |
First Posted: | April 25, 2019 Key Record Dates |
Last Update Posted: | February 2, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Feeding and Eating Disorders Mental Disorders |