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Clinical Trials/NCT01740752
NCT01740752
Completed
Not Applicable

Enhancing Treatment for Adult Anorexia With a Couple-Based Approach

University of North Carolina, Chapel Hill1 site in 1 country70 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
University of North Carolina, Chapel Hill
Enrollment
70
Locations
1
Primary Endpoint
Change in Body Mass Index (BMI) from baseline through 12 month follow-up
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
January 17, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Body Mass Index (BMI) from baseline through 12 month follow-up

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.

Change in Global Eating Disorder Examination (EDE) Scores from baseline through 12 month follow-up

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.

Secondary Outcomes

  • Dropout (the percentage of individuals who withdrew participation from treatment)(Month 6/ end-treatment assessment)
  • Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ)(Month 6/ end-treatment assessment)
  • Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4(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.)

Study Sites (1)

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