UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT01740752
Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment research study between the University of North Carolina (UNC) Eating Disorders Program and the UNC Department of Psychology and is funded by the National Institute of Mental Health. The study examines two comprehensive treatments as couples face the challenges of anorexia nervosa (AN). The program helps patients with AN and their partners address AN symptoms and unique stresses that AN places on the romantic relationship.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
No single, conventional treatment has been shown to significantly benefit adults with AN, which ranks among the leading causes of disability and premature death in young women. The investigators propose to test the hypothesis that a novel, couple-based intervention developed for adult AN (UCAN) significantly enhances treatment outcome and reduces risk of relapse compared with treatment conducted entirely on an individual basis, the standard mode of treatment delivery in the community. The investigators plan to compare UCAN with individual treatment in a randomized controlled trial (RCT). All participants with AN will receive a common set of core interventions, including medical management, nutrition counseling, and a base level of individual cognitive-behavioral therapy (CBT), with randomization either to: 1) UCAN couple-based intervention or 2) a higher "dose" of individual CBT. The partners are involved in varying ways and to varying degrees in treatment. In addition, progress will be followed for one year after completion of active treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
weekly manualized couple therapy plus weekly manualized individual CBT
Other names: CBCT
weekly manualized higher "dose" of individual CBT
Time frame: BMI is measured at baseline, weekly during the first 6 months (while in active treatment), and at each time point through 12 month follow-up
BMI is a measure of body fat based on height and weight that the study is using to track weight changes throughout the course of the study. In AN, weight loss indicates the severity of the disease and weight gain is associated with recovery. Therefore, BMI is used to track progress in recovery.
Time frame: The EDE is assessed at baseline and each time point from end-treatment through the 12 month follow-up
The EDE measures the frequency in which a patient engages in behaviors indicative of an eating disorder over a 28 day period.
Time frame: Month 6/ end-treatment assessment
Dropout will be compared in the two treatment groups to see if a certain intervention enhances compliance with treatment.
Time frame: Month 6/ end-treatment assessment
Treatment satisfaction is measured at end-treatment with CSQ. The CSQ rates effectiveness of, and satisfaction with services received.
Time frame: Baseline through 12 month follow-up. Also, all patients and partners in the UCAN + CBT group only rate relationship satisfaction weekly (up to 23 weeks) during active treatment.
Extent to which someone is happy in his or her relationship.
Time frame: Cost effectiveness is measured at each time point from 3 month follow-up to 12 month follow-up
The cost effectiveness ratio will be calculated using utilization data from the McKnight Follow-up of Eating Disorders (MFED).
University of North Carolina, Chapel Hill
Other
Enhancing Treatment for Adult Anorexia With a Couple-Based Approach
Acronym: UCAN2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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