UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

University of North Carolina, Chapel Hill70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anorexia Nervosa

Interventions

UCAN+CBTBEHAVIORAL

weekly manualized couple therapy plus weekly manualized individual CBT

CBTBEHAVIORAL

weekly manualized higher "dose" of individual CBT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

UNC Center of Excellence for Eating Disorders

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Change in Body Mass Index (BMI) from baseline 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.

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

Change in Global Eating Disorder Examination (EDE) Scores from baseline through 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.

Time frame: The EDE is assessed at baseline and each time point from end-treatment through the 12 month follow-up

Secondary Outcomes

Dropout (the percentage of individuals who withdrew participation from treatment)

Dropout will be compared in the two treatment groups to see if a certain intervention enhances compliance with treatment.

Time frame: Month 6/ end-treatment assessment

Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ)

Treatment satisfaction is measured at end-treatment with CSQ. The CSQ rates effectiveness of, and satisfaction with services received.

Time frame: Month 6/ end-treatment assessment

Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4

Extent to which someone is happy in his or her relationship.

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.

Data from ClinicalTrials.gov

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