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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00928109
Other study ID # 07-1429
Secondary ID R01MH082732-01
Status Completed
Phase N/A
First received June 23, 2009
Last updated November 8, 2012
Start date April 2008
Est. completion date June 2012

Study information

Verified date November 2012
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
CBCT
Cognitive Behavioral Couples Therapy - weekly manualized couples therapy
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

Locations

Country Name City State
United States UNC Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eating disorder behavior 9 months No
Secondary Couple Satisfaction 9 months No
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