Trial record 14 of 59 for:    Open Studies | "Anorexia"

UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01740752
First received: November 8, 2012
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention
Anorexia Nervosa
Behavioral: UCAN+CBT
Behavioral: CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Treatment for Adult Anorexia With a Couple-Based Approach

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Dropout (the percentage of individuals who withdrew participation from treatment) [ Time Frame: Month 6/ end-treatment assessment ] [ Designated as safety issue: No ]
    Dropout will be compared in the two treatment groups to see if a certain intervention enhances compliance with treatment.

  • Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ) [ Time Frame: Month 6/ end-treatment assessment ] [ Designated as safety issue: No ]
    Treatment satisfaction is measured at end-treatment with CSQ. The CSQ rates effectiveness of, and satisfaction with services received.

  • 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. ] [ Designated as safety issue: No ]
    Extent to which someone is happy in his or her relationship.


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The cost effectiveness ratio will be calculated using utilization data from the McKnight Follow-up of Eating Disorders (MFED).


Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 16.0-19.0 currently or sometime in the past month.
    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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740752

Contacts
Contact: Kathryn Nowlan, B.A. 919-843-2483 ucan@unc.edu

Locations
United States, North Carolina
UNC Center of Excellence for Eating Disorders Recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Cynthia Bulik, PhD UNC Chapel Hill Department of Psychiatry
Principal Investigator: Donald Baucom, PhD UNC Chapel Hill Department of Psychology
  More Information

Additional Information:
No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01740752     History of Changes
Other Study ID Numbers: 11-1990, 1R01MH093615-01A1
Study First Received: November 8, 2012
Last Updated: July 11, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
anorexia nervosa
eating disorder
couples
relationships
couple therapy

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014