Anorexia NervosaUCAN2NCT01740752
UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa
A study testing UCAN+CBT and CBT in people with Anorexia Nervosa, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment research study between the University of North Carolina (UNC) Eating Disorders Program and the UNC Department of Psychology and is funded by the National Institute of Mental Health. 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?
- UCAN+CBT and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 17 Jan 2019
- 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
- Participant with AN must have:
- Current Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (Text Revision) (DSM-IV-TR) criteria for AN, restricting or binge/purge subtype; BMI between 15.0-19.0 currently or sometime in the past 3 months.
- Adequate insurance coverage to support a higher level of care including but not limited to partial hospitalization or inpatient treatment.
- Both members of couple must be:
- At least 18 years of age.
- English speaking.
- Involved in a committed relationship for at least 6 months, regardless of sexual orientation.
- Wiling to participate in treatment.
Who cannot join
- Participant with AN cannot be: Unwilling to suspend other treatment for AN for the duration of the study.
- Partner cannot meet: Current DSM-IV-TR criteria for AN, restricting or binge/purge subtype. We will exclude couples in which both partners have a diagnosis of AN.
- Neither member of couple can have:
- Alcohol or drug dependence in the past year.
- Current significant suicidal ideation (from interview or depression assessment).
- Severe depression that would seriously interfere with functional capacity, as judged by the PIs or study physician.
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- Developmental disability that would impair the ability to benefit from the intervention.
- Any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year.
- Moderate to high levels of physical violence from participant/partner as reported during baseline interview.
- Previously participated in the UCAN couple treatment condition in the preliminary couples treatment study (#07-1429. UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, 27599
About this study
Official title: Enhancing Treatment for Adult Anorexia With a Couple-Based Approach
Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment research study between the University of North Carolina (UNC) Eating Disorders Program and the UNC Department of Psychology and is funded by the National Institute of Mental Health. The study examines two comprehensive treatments as couples face the challenges of anorexia nervosa (AN). The program helps patients with AN and their partners address AN symptoms and unique stresses that AN places on the romantic relationship.
Read the detailed description
No single, conventional treatment has been shown to significantly benefit adults with AN, which ranks among the leading causes of disability and premature death in young women. The investigators propose to test the hypothesis that a novel, couple-based intervention developed for adult AN (UCAN) significantly enhances treatment outcome and reduces risk of relapse compared with treatment conducted entirely on an individual basis, the standard mode of treatment delivery in the community. The investigators plan to compare UCAN with individual treatment in a randomized controlled trial (RCT). All participants with AN will receive a common set of core interventions, including medical management, nutrition counseling, and a base level of individual cognitive-behavioral therapy (CBT), with randomization either to: 1) UCAN couple-based intervention or 2) a higher "dose" of individual CBT. The partners are involved in varying ways and to varying degrees in treatment. In addition, progress will be followed for one year after completion of active treatment.
- Conditions
- Anorexia Nervosa
- Being tested
- UCAN+CBT, CBT
- Keywords
- anorexia nervosa, eating disorder, couples, relationships, couple 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.
UCAN+CBTBehavioural
Also called CBCT
weekly manualized couple therapy plus weekly manualized individual CBT
CBTBehavioural
weekly manualized higher "dose" of individual CBT
| Study group | Role | What they receive |
|---|---|---|
| UCAN+CBT | Experimental | This condition includes 22 UCAN sessions and 22 CBT sessions, totaling 44 psychotherapy sessions. UCAN is a manualized, 22-session Cognitive Behavioral Couple Therapy (CBCT) intervention that engages the couple to target the core psychopathology of AN and address the uniquely challenging stress that AN places on intimate relationships. The CBT proposed for this study is a 22 session adaptation of the manualized intervention that has been employed successfully as an outpatient post-hospitalization therapy and in an National Institute of Mental Health multisite study of fluoxetine with elements from the CBT manual used in McIntosh et al (PubMed 15800147). Receives: Behavioral: UCAN+CBT |
| CBT | Experimental | In this condition, participants will receive a higher "dose" of individual CBT, with 44 total sessions. Our experience with patients in the pilot strongly suggests that a higher dose of CBT will allow for further, fruitful discussion and exploration of key individual issues and is unlikely to be experienced as diluted or a slow approach to treatment. Most of these patients have complicated histories, long-standing eating disorders, and complex comorbid conditions. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) from baseline through 12 month follow-up
BMI is a measure of body fat based on height and weight that the study is using to track weight changes throughout the course of the study. In AN, weight loss indicates the severity of the disease and weight gain is associated with recovery. Therefore, BMI is used to track progress in recovery.
Measured: BMI is measured at baseline, weekly during the first 6 months (while in active treatment), and at each time point through 12 month follow-up
Change in Global Eating Disorder Examination (EDE) Scores from baseline through 12 month follow-up
The EDE measures the frequency in which a patient engages in behaviors indicative of an eating disorder over a 28 day period.
Measured: The EDE is assessed at baseline and each time point from end-treatment through the 12 month follow-up
Secondary outcomes (3)
Dropout (the percentage of individuals who withdrew participation from treatment)
Dropout will be compared in the two treatment groups to see if a certain intervention enhances compliance with treatment.
Measured: Month 6/ end-treatment assessment
Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ)
Treatment satisfaction is measured at end-treatment with CSQ. The CSQ rates effectiveness of, and satisfaction with services received.
Measured: Month 6/ end-treatment assessment
Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4
Extent to which someone is happy in his or her relationship.
Measured: Baseline through 12 month follow-up. Also, all patients and partners in the UCAN + CBT group only rate relationship satisfaction weekly (up to 23 weeks) during active treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startJul 2012
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
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
- 70 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 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
- NCT01740752
- Sponsor's protocol ID
- 11-1990
- Other IDs
- 1R01MH093615-01A1
- Acronym
- UCAN2
- Status last verified
- Jan 2019
- First submitted
- 8 Nov 2012
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Treatment for Adult Anorexia With a Couple-Based Approach
- ClinicalTrials.gov ID
- NCT01740752
- Acronym / sponsor ID
- UCAN2 / 11-1990
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, eating disorder, couples, relationships, couple therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2012 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 4 Dec 2012 (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.
Uniting Couples in the treatment of Anorexia Nervosa (UCAN2) is a collaborative treatment research study between the University of North Carolina (UNC) Eating Disorders Program and the UNC Department of Psychology and is funded by the National Institute of Mental Health. The study examines two comprehensive treatments as couples face the challenges of anorexia nervosa (AN). The program helps patients with AN and their partners address AN symptoms and unique stresses that AN places on the romantic relationship.
Detailed description
No single, conventional treatment has been shown to significantly benefit adults with AN, which ranks among the leading causes of disability and premature death in young women. The investigators propose to test the hypothesis that a novel, couple-based intervention developed for adult AN (UCAN) significantly enhances treatment outcome and reduces risk of relapse compared with treatment conducted entirely on an individual basis, the standard mode of treatment delivery in the community. The investigators plan to compare UCAN with individual treatment in a randomized controlled trial (RCT). All participants with AN will receive a common set of core interventions, including medical management, nutrition counseling, and a base level of individual cognitive-behavioral therapy (CBT), with randomization either to: 1) UCAN couple-based intervention or 2) a higher "dose" of individual CBT. The partners are involved in varying ways and to varying degrees in treatment. In addition, progress will be followed for one year after completion of active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCAN+CBT | Experimental | Behavioral: UCAN+CBTThis condition includes 22 UCAN sessions and 22 CBT sessions, totaling 44 psychotherapy sessions. UCAN is a manualized, 22-session Cognitive Behavioral Couple Therapy (CBCT) intervention that engages the couple to target the core psychopathology of AN and address the uniquely challenging stress that AN places on intimate relationships. The CBT proposed for this study is a 22 session adaptation of the manualized intervention that has been employed successfully as an outpatient post-hospitalization therapy and in an National Institute of Mental Health multisite study of fluoxetine with elements from the CBT manual used in McIntosh et al (PubMed 15800147). |
| CBT | Experimental | Behavioral: CBTIn this condition, participants will receive a higher "dose" of individual CBT, with 44 total sessions. Our experience with patients in the pilot strongly suggests that a higher dose of CBT will allow for further, fruitful discussion and exploration of key individual issues and is unlikely to be experienced as diluted or a slow approach to treatment. Most of these patients have complicated histories, long-standing eating disorders, and complex comorbid conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant with AN must have:
- Both members of couple must be:
Key exclusion criteria (10 listed)
- Participant with AN cannot be: Unwilling to suspend other treatment for AN for the duration of the study.
- Partner cannot meet: Current DSM-IV-TR criteria for AN, restricting or binge/purge subtype. We will exclude couples in which both partners have a diagnosis of AN.
- Neither member of couple can have:
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 |
|---|---|---|
| UCAN+CBTAlso: CBCTweekly manualized couple therapy plus weekly manualized individual CBT | Behavioural | UCAN+CBT |
| CBTweekly manualized higher "dose" of individual CBT | Behavioural | CBT |
Primary outcome
Change in Body Mass Index (BMI) from baseline through 12 month follow-up
Time frame: BMI is measured at baseline, weekly during the first 6 months (while in active treatment), and at each time point through 12 month follow-up
BMI is a measure of body fat based on height and weight that the study is using to track weight changes throughout the course of the study. In AN, weight loss indicates the severity of the disease and weight gain is associated with recovery. Therefore, BMI is used to track progress in recovery.
Change in Global Eating Disorder Examination (EDE) Scores from baseline through 12 month follow-up
Time frame: The EDE is assessed at baseline and each time point from end-treatment through the 12 month follow-up
The EDE measures the frequency in which a patient engages in behaviors indicative of an eating disorder over a 28 day period.
3 secondary outcomes
Dropout (the percentage of individuals who withdrew participation from treatment)
Time frame: Month 6/ end-treatment assessment
Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ)
Time frame: Month 6/ end-treatment assessment
Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4
Time frame: Baseline through 12 month follow-up. Also, all patients and partners in the UCAN + CBT group only rate relationship satisfaction weekly (up to 23 weeks) during active treatment.
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 24 Jan 2019.
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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 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 UCAN+CBT and CBT 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 8 inclusion and 10 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 24 Jan 2019. 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?
Change in Body Mass Index (BMI) from baseline through 12 month follow-up (time frame: BMI is measured at baseline, weekly during the first 6 months (while in active treatment), and at each time point through 12 month follow-up). The study lists 2 primary outcomes in all. 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 24 Jan 2019.