N/A
N=177
Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT
Anorexia Nervosa
Bottom Line
View on ClinicalTrials.gov: NCT03928028 ↗Enrolled (actual)
177
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS — 11.89; 10.94; 11.47; 11.14 score on a scale — p=.507
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Remediation Therapy (Behavioral); Family Based Treatment (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS |
11.89; 10.94; 11.47; 11.14; 11.86; 12.00 | .507 |
| PRIMARY Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS |
11.95; 11.84; 12.21; 12.72; 12.06; 12.94 | .389 |
| PRIMARY Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS |
11.71; 11.05; 11.95; 12.78; 12.50; 12.78 | .778 |
| PRIMARY Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS |
11.90; 11.68; 11.95; 11.63; 11.56; 11.24 | .196 |
| PRIMARY Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS |
11.90; 11.68; 11.95; 11.63; 11.56; 11.24 | .196 |
| PRIMARY Change in Cognitive Flexibility - Sorting Test Description of DKEFS |
11.94; 11.47; 12.47; 12.21; 12.38; 13.50 | .446 |
| PRIMARY Change in Self-Reported Shifting - BRIEF |
58.38; 53.21; 51.79; 56.47; 56.31; 54.28 | .425 |
| PRIMARY Dose of CRT |
0; 8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03928028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.