UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa (UCAN2)
|ClinicalTrials.gov Identifier: NCT01740752|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : March 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anorexia Nervosa||Behavioral: UCAN+CBT Behavioral: CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Enhancing Treatment for Adult Anorexia With a Couple-Based Approach|
|Actual Study Start Date :||July 2012|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
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
- 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.
- Dropout (the percentage of individuals who withdrew participation from treatment) [ 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.
- Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ) [ 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.
- 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. ]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 ]The cost effectiveness ratio will be calculated using utilization data from the McKnight Follow-up of Eating Disorders (MFED).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740752
|United States, North Carolina|
|UNC Center of Excellence for Eating Disorders|
|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|