UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

University of North Carolina (UNC)

Status: Completed

Conditions: Anorexia Nervosa

Treatments: Behavioral: CBT; Behavioral: UCAN+CBT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01740752

1R01MH093615-01A1 (U.S. NIH Grant/Contract)

11-1990

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

UCAN+CBT

Experimental group

Description:

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).

Treatment:

Behavioral: UCAN+CBT

CBT

Experimental group

Description:

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.

Treatment:

Behavioral: CBT