UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Enhancing Treatment for Adult Anorexia With a Couple-Based Approach|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The EDE measures the frequency in which a patient engages in behaviors indicative of an eating disorder over a 28 day period.
- Dropout (the percentage of individuals who withdrew participation from treatment) [ Time Frame: Month 6/ end-treatment assessment ] [ Designated as safety issue: No ]Dropout will be compared in the two treatment groups to see if a certain intervention enhances compliance with treatment.
- Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ) [ Time Frame: Month 6/ end-treatment assessment ] [ Designated as safety issue: No ]Treatment satisfaction is measured at end-treatment with CSQ. The CSQ rates effectiveness of, and satisfaction with services received.
- Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4 [ 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. ] [ Designated as safety issue: No ]Extent to which someone is happy in his or her relationship.
- Cost effectiveness ratio (is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment) [ Time Frame: Cost effectiveness is measured at each time point from 3 month follow-up to 12 month follow-up ] [ Designated as safety issue: No ]The cost effectiveness ratio will be calculated using utilization data from the McKnight Follow-up of Eating Disorders (MFED).
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
This condition includes 22 UCAN sessions and 22 CBT sessions, totaling 44 psychotherapy sessions. UCAN is a manualized, 22-session Cognitive Behavioral Couple Therapy (CBCT) intervention that engages the couple to target the core psychopathology of AN and address the uniquely challenging stress that AN places on intimate relationships. The CBT proposed for this study is a 22 session adaptation of the manualized intervention that has been employed successfully as an outpatient post-hospitalization therapy and in an National Institute of Mental Health multisite study of fluoxetine with elements from the CBT manual used in McIntosh et al (PubMed 15800147).
weekly manualized couple therapy plus weekly manualized individual CBT
Other Name: CBCT
In this condition, participants will receive a higher "dose" of individual CBT, with 44 total sessions. Our experience with patients in the pilot strongly suggests that a higher dose of CBT will allow for further, fruitful discussion and exploration of key individual issues and is unlikely to be experienced as diluted or a slow approach to treatment. Most of these patients have complicated histories, long-standing eating disorders, and complex comorbid conditions.
weekly manualized higher "dose" of individual CBT
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740752
|Contact: Kathryn Nowlan, B.A.||firstname.lastname@example.org|
|United States, North Carolina|
|UNC Center of Excellence for Eating Disorders||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Cynthia Bulik, PhD||UNC Chapel Hill Department of Psychiatry|
|Principal Investigator:||Donald Baucom, PhD||UNC Chapel Hill Department of Psychology|