Anorexia NervosaUCANNCT00928109
UCAN: Uniting Couples in the Treatment of Anorexia Nervosa
A study testing CBCT and Family Supportive Therapy in people with Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- CBCT and Family Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- CBCT, Family Supportive Therapy
- Keywords
- eating disorders, couples therapy
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTBehavioural
Also called UCAN
Cognitive Behavioral Couples Therapy - weekly manualized couples therapy
Family Supportive TherapyBehavioural
Also called Eating Disorder Treatment as Usual
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Family Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating disorder behavior
Measured: 9 months
Secondary outcomes (1)
Couple Satisfaction
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cynthia M Bulik, PhD, Principal investigator, UNC Chapel Hill Department of PsychiatryDonald Baucom, PhD, Principal investigator, UNC Chapel Hill Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928109
- Sponsor's protocol ID
- 07-1429
- Other IDs
- R01MH082732-01
- Acronym
- UCAN
- Status last verified
- Nov 2012
- First submitted
- 23 Jun 2009
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Trial for the Treatment of Anorexia Nervosa in Late Adolescence and Adulthood
- ClinicalTrials.gov ID
- NCT00928109
- Acronym / sponsor ID
- UCAN / 07-1429
- Conditions
- Anorexia Nervosa
- Keywords
- eating disorders, couples therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Couples Therapy (CBCT) | Experimental | Behavioral: CBCTCBCT 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. |
| Family Supportive Therapy | Active comparator | Behavioral: Family Supportive TherapyCouples 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCTAlso: UCANCognitive Behavioral Couples Therapy - weekly manualized couples therapy | Behavioural | Cognitive Behavioral Couples Therapy (CBCT) |
| Family Supportive TherapyAlso: Eating Disorder Treatment as UsualCouples 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 | Behavioural | Family Supportive Therapy |
Primary outcome
Eating disorder behavior
Time frame: 9 months
1 secondary outcome
Couple Satisfaction
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia M Bulik, PhD principal investigator
UNC Chapel Hill Department of Psychiatry
Donald Baucom, PhD principal investigator
UNC Chapel Hill Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT and Family Supportive Therapy in people with Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorder behavior (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.