Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT (NCT05017831) | Clinical Trial Compass
CompletedNot Applicable
Shifting Perspectives R33 Phase: Enhancing Outcomes in Anorexia Nervosa With CRT
United States283 participantsStarted 2021-11-05
Plain-language 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 affected adolescents in the hopes that improvements in set-shifting will, ultimately, improve outcome.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 lives with the adolescent
✓. Age \>18
Exclusion criteria
✕. Adolescent outside age range
✕. No more than four sessions of prior CRT in any format
✕. Presence of: a brain disorder or injury (such as TBI) that could impact the ability to engage in treatment
✕. Use of anti-psychotic medication during first 15 FBT sessions. Use of this medication is permitted in the optional 12 FBT sessions in the 6-month follow-up period of this study. This medication can affect cognitive abilities, which may interact with assessments that measure cognitive flexibility. However, we do not measure cognitive flexibility in the 6-month follow-up period when the 12 additional FBT sessions can take place.
What they're measuring
1
Change in executive functioning
Timeframe: Baseline, during treatment, end of treatment
2
Change in response inhibition
Timeframe: Baseline, during treatment, end of treatment
3
Change in set-shifting
Timeframe: Baseline, during treatment, end of treatment
4
Change in shifting accuracy
Timeframe: Baseline, during treatment, end of treatment
5
Change in category switching flexibility
Timeframe: Baseline, during treatment, end of treatment
6
Change in flexibility
Timeframe: Baseline, during treatment, end of treatment
7
Change in self-reported inhibition control
Timeframe: Baseline, during treatment, end of treatment
8
Change in self-reported set-shifting
Timeframe: Baseline, during treatment, end of treatment