- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928109
UCAN: Uniting Couples in the Treatment of Anorexia Nervosa (UCAN)
November 8, 2012 updated by: University of North Carolina, Chapel Hill
Innovative Trial for the Treatment of Anorexia Nervosa in Late Adolescence and Adulthood
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Chapel Hill
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Behavioral Couples Therapy (CBCT)
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.
|
Cognitive Behavioral Couples Therapy - weekly manualized couples therapy
Other Names:
|
|
Active Comparator: Family Supportive Therapy
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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eating disorder behavior
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Couple Satisfaction
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Cynthia M Bulik, PhD, UNC Chapel Hill Department of Psychiatry
- Principal Investigator: Donald Baucom, PhD, UNC Chapel Hill Department of Psychology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
June 23, 2009
First Submitted That Met QC Criteria
June 24, 2009
First Posted (Estimate)
June 25, 2009
Study Record Updates
Last Update Posted (Estimate)
November 9, 2012
Last Update Submitted That Met QC Criteria
November 8, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-1429
- R01MH082732-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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