NCT00928109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

4.2 years

First QC Date

June 23, 2009

Last Update Submit

November 8, 2012

Conditions

Anorexia Nervosa

Keywords

eating disorderscouples therapy

Outcome Measures

Primary Outcomes (1)

  • Eating disorder behavior

    9 months

Secondary Outcomes (1)

  • Couple Satisfaction

    9 months

Study Arms (2)

Cognitive Behavioral Couples Therapy (CBCT)

EXPERIMENTAL

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.

Behavioral: CBCT

Family Supportive Therapy

ACTIVE COMPARATOR

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

Behavioral: Family Supportive Therapy

Interventions

CBCTBEHAVIORAL

Cognitive Behavioral Couples Therapy - weekly manualized couples therapy

Also known as: UCAN
Cognitive Behavioral Couples Therapy (CBCT)
Family Supportive TherapyBEHAVIORAL

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

Also known as: Eating Disorder Treatment as Usual
Family Supportive Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cynthia M Bulik, PhD

    UNC Chapel Hill Department of Psychiatry

    PRINCIPAL INVESTIGATOR

  • Donald Baucom, PhD

    UNC Chapel Hill Department of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

April 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

US(1)