Clinical trial NCT01740752: UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa
Official title: Enhancing Treatment for Adult Anorexia With a Couple-Based Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
eating disorder
couples
relationships
couple therapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. Participant with AN must have:

   1. Current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (Text Revision) (DSM-IV-TR) criteria for AN, restricting or binge/purge subtype; BMI between 15.0-19.0 currently or sometime in the past 3 months.
   2. Adequate insurance coverage to support a higher level of care including but not limited to partial hospitalization or inpatient treatment.
2. Both members of couple must be:

   1. At least 18 years of age.
   2. English speaking.
   3. Involved in a committed relationship for at least 6 months, regardless of sexual orientation.
   4. Wiling to participate in treatment.

Exclusion Criteria

1. Participant with AN cannot be: Unwilling to suspend other treatment for AN for the duration of the study.
2. Partner cannot meet: Current DSM-IV-TR criteria for AN, restricting or binge/purge subtype. We will exclude couples in which both partners have a diagnosis of AN.
3. Neither member of couple can have:

   1. Alcohol or drug dependence in the past year.
   2. Current significant suicidal ideation (from interview or depression assessment).
   3. Severe depression that would seriously interfere with functional capacity, as judged by the PIs or study physician.
   4. Developmental disability that would impair the ability to benefit from the intervention.
   5. Any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year.
   6. Moderate to high levels of physical violence from participant/partner as reported during baseline interview.
   7. 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)

Primary outcomes:
measure: Change in Body Mass Index (BMI) from baseline through 12 month follow-up
timeFrame: 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
measure: Change in Global Eating Disorder Examination (EDE) Scores from baseline through 12 month follow-up
timeFrame: The EDE is assessed at baseline and each time point from end-treatment through the 12 month follow-up
Secondary outcomes:
measure: Dropout (the percentage of individuals who withdrew participation from treatment)
timeFrame: Month 6/ end-treatment assessment
measure: Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ)
timeFrame: Month 6/ end-treatment assessment
measure: Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4
timeFrame: 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.
Other outcomes:
measure: Cost effectiveness ratio (is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment)
timeFrame: Cost effectiveness is measured at each time point from 3 month follow-up to 12 month follow-up
Locations:
city: Chapel Hill
country: United States
facility: UNC Center of Excellence for Eating Disorders
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill Department of Psychiatry
name: Cynthia Bulik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill Department of Psychology
name: Donald Baucom, PhD
role: PRINCIPAL_INVESTIGATOR
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