Bulik 2012.

Trial name or title	Enhancing treatment for adult anorexia with a couple‐based approach
Methods	Randomised parallel assignment
Participants	Inclusion criteria Participants with AN must have: Current DSM‐IV‐TR criteria for AN, restricting or binge/purge subtype; BMI between 15.0 and 19.0 or sometime in the past 3 months Adequate insurance coverage to support a higher level of care including but not limited to partial hospitalisation or inpatient treatment Both members of couple must be: At least 18 years of age English‐speaking Involved in a committed relationship for at least 6 months, regardless of sexual orientation Wiling to participate in treatment Exclusion criteria Unwilling to suspend other treatment for AN for the duration of the study Partner cannot meet: current DSM‐IV‐TR criteria for AN, restricting or binge/purge subtype. Couples in which both individuals have a diagnosis of AN will be excluded Neither member of couple can have: Alcohol or drug dependence in past year Current significant suicidal ideation (from interview or depression assessment) Severe depression that would seriously interfere with functional capacity, as judged by the PIs or study physician Developmental disability that would impair the ability to benefit from the intervention Any psychosis, schizophrenia, or bipolar I disorder unless stably remitted on maintenance therapy for at least 1 year Moderate to high levels of physical violence from participant/partner as reported during baseline interview Previously participated in the UCAN couple treatment condition in the preliminary couples treatment study (#07‐1429. UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa)
Interventions	Intervention group 1 Description: Uniting Couples in the Treatment of Anorexia Nervosa (UCAN) + Cognitive Behavioural Therapy (CBT) This condition includes 22 UCAN sessions and 22 CBT sessions, totaling 44 psychotherapy sessions. UCAN is a manualised, 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 manualised intervention that has been employed successfully as an outpatient post‐hospitalisation therapy and in an National Institute of Mental Health multi‐site study of fluoxetine with elements from the CBT manual used in McIntosh 2005. Intervention group 2 Description: CBT 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.
Outcomes	Primary outcomes: 1. Change in BMI from baseline through 12 month follow‐up 2. Change in Global EDE Scores from baseline through 12 month follow‐up Secondary outcomes: 1. Dropout (the percentage of individuals who withdrew participation from treatment) 2. Treatment satisfaction scores as measured with the CSQ 3. Relationship satisfaction as measured with the DAS and DAS‐4 (measures extent to which someone is happy in his or her relationship) Other outcomes: 1. Cost effectiveness ratio (= the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment. It will be calculated using data from the MFED
Starting date	July 2012
Contact information	Camden Matherne, Ph.D; ph: 9119‐843‐2483; email: ucan @unc.edu
Notes	clinicaltrials.gov/show/NCT01740752