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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBCT
Family Supportive Therapy
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring eating disorders, couples therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anorexia Nervosa,
  • 18 years or older,
  • BMI 16 or higher,
  • In a committed relationship with a partner for 1 year or longer and currently living together.

Exclusion Criteria:

  • Alcohol or drug dependence in past year,
  • Current significant suicidal ideation,
  • Developmental disability that would impair the ability of the participant to benefit from the intervention,
  • Psychosis,
  • BMI less than 16.

Sites / Locations

  • UNC Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioral Couples Therapy (CBCT)

Family Supportive Therapy

Arm Description

CBCT is a 20-week program consisting of 1-hour sessions between a couple and a therapist. In this program, couples learn about ways to communicate about their relationship in the context of experiencing anorexia nervosa. CBCT focuses on couple-specific skills such as communication and targets relationship domains such as exercise, body image and sexuality, eating together as a couple, and broader relationship concerns outside of anorexia nervosa.

Couples meet once a week for an hour for a period of 20 weeks for couples therapy. Family Supportive Therapy is not manualized and is the standard form of care at the UNC Eating Disorders Program

Outcomes

Primary Outcome Measures

Eating disorder behavior

Secondary Outcome Measures

Couple Satisfaction

Full Information

First Posted
June 23, 2009
Last Updated
November 8, 2012
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00928109
Brief Title
UCAN: Uniting Couples in the Treatment of Anorexia Nervosa
Acronym
UCAN
Official Title
Innovative Trial for the Treatment of Anorexia Nervosa in Late Adolescence and Adulthood
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
UCAN is a research program funded by the National Institute of Mental Health and is part of the UNC Eating Disorders Program. UCAN aims to help couples work together in the treatment of anorexia nervosa. Couples participate in UCAN over a period of six months and return for follow-up treatment three months after the end of the original six-month period. Patients receive weekly individual therapy, monthly psychiatry consultations, monthly dietary consultations in addition to being randomized to one of two types of weekly couples therapy. Participation in UCAN can help participants gain new confidence in facing anorexia as a team and can help us understand how best to involve partners in the treatment of eating disorders.
Detailed Description
Patients receive comprehensive eating disorder treatment at the UNC Eating Disorders Outpatient Program in addition to couples therapy. Eligibility: Participants may be eligible if they are 18 or older, have anorexia nervosa and are currently living with a partner with whom they have been in a committed relationship for at least a year. The partner must also be willing to enter treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
eating disorders, couples therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Couples Therapy (CBCT)
Arm Type
Experimental
Arm Description
CBCT is a 20-week program consisting of 1-hour sessions between a couple and a therapist. In this program, couples learn about ways to communicate about their relationship in the context of experiencing anorexia nervosa. CBCT focuses on couple-specific skills such as communication and targets relationship domains such as exercise, body image and sexuality, eating together as a couple, and broader relationship concerns outside of anorexia nervosa.
Arm Title
Family Supportive Therapy
Arm Type
Active Comparator
Arm Description
Couples meet once a week for an hour for a period of 20 weeks for couples therapy. Family Supportive Therapy is not manualized and is the standard form of care at the UNC Eating Disorders Program
Intervention Type
Behavioral
Intervention Name(s)
CBCT
Other Intervention Name(s)
UCAN
Intervention Description
Cognitive Behavioral Couples Therapy - weekly manualized couples therapy
Intervention Type
Behavioral
Intervention Name(s)
Family Supportive Therapy
Other Intervention Name(s)
Eating Disorder Treatment as Usual
Intervention Description
Couples meet once a week for an hour for a period of 20 weeks for couples therapy. Family Supportive Therapy is not manualized and is the standard form of care at the UNC Eating Disorders Program
Primary Outcome Measure Information:
Title
Eating disorder behavior
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Couple Satisfaction
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anorexia Nervosa, 18 years or older, BMI 16 or higher, In a committed relationship with a partner for 1 year or longer and currently living together. Exclusion Criteria: Alcohol or drug dependence in past year, Current significant suicidal ideation, Developmental disability that would impair the ability of the participant to benefit from the intervention, Psychosis, BMI less than 16.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia M Bulik, PhD
Organizational Affiliation
UNC Chapel Hill Department of Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald Baucom, PhD
Organizational Affiliation
UNC Chapel Hill Department of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

UCAN: Uniting Couples in the Treatment of Anorexia Nervosa

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