COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa (UCAN2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01740752
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : January 24, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: UCAN+CBT Behavioral: CBT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Treatment for Adult Anorexia With a Couple-Based Approach
Actual Study Start Date : July 2012
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 17, 2019

Arm Intervention/treatment
Experimental: UCAN+CBT
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).
Behavioral: UCAN+CBT
weekly manualized couple therapy plus weekly manualized individual CBT
Other Name: CBCT

Experimental: 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.
Behavioral: CBT
weekly manualized higher "dose" of individual CBT

Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Other Outcome Measures:
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01740752

Layout table for location information
United States, North Carolina
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Layout table for investigator information
Principal Investigator: Cynthia Bulik, PhD UNC Chapel Hill Department of Psychiatry
Principal Investigator: Donald Baucom, PhD UNC Chapel Hill Department of Psychology
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01740752    
Other Study ID Numbers: 11-1990
1R01MH093615-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by University of North Carolina, Chapel Hill:
anorexia nervosa
eating disorder
couple therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders