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UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa (UCAN2)

Primary Purpose

Anorexia Nervosa

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UCAN+CBT

CBT

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring anorexia nervosa, eating disorder, couples, relationships, couple therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Participant with AN must have:
1. 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.
2. 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:
1. At least 18 years of age.
2. English speaking.
3. Involved in a committed relationship for at least 6 months, regardless of sexual orientation.
4. Wiling to participate in treatment.

Exclusion Criteria

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:
1. Alcohol or drug dependence in the past year.
2. Current significant suicidal ideation (from interview or depression assessment).
3. Severe depression that would seriously interfere with functional capacity, as judged by the PIs or study physician.
4. Developmental disability that would impair the ability to benefit from the intervention.
5. Any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year.
6. Moderate to high levels of physical violence from participant/partner as reported during baseline interview.
7. 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)

Sites / Locations

UNC Center of Excellence for Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

UCAN+CBT

CBT

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4

Extent to which someone is happy in his or her relationship.

Full Information

NCT ID

NCT01740752

First Posted

November 8, 2012

Last Updated

January 22, 2019

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01740752

Brief Title

UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

Acronym

UCAN2

Official Title

Enhancing Treatment for Adult Anorexia With a Couple-Based Approach

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

July 2012 (Actual)

Primary Completion Date

January 17, 2019 (Actual)

Study Completion Date

January 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa

Keywords

anorexia nervosa, eating disorder, couples, relationships, couple therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UCAN+CBT

Arm Type

Experimental

Arm Description

Arm Title

CBT

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

UCAN+CBT

Other Intervention Name(s)

CBCT

Intervention Description

weekly manualized couple therapy plus weekly manualized individual CBT

Intervention Type

Behavioral

Intervention Name(s)

CBT

Intervention Description

weekly manualized higher "dose" of individual CBT

Primary Outcome Measure Information:

Title

Change in Body Mass Index (BMI) from baseline through 12 month follow-up

Description

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

Title

Change in Global Eating Disorder Examination (EDE) Scores from baseline through 12 month follow-up

Description

The EDE measures the frequency in which a patient engages in behaviors indicative of an eating disorder over a 28 day period.

Time Frame

The EDE is assessed at baseline and each time point from end-treatment through the 12 month follow-up

Secondary Outcome Measure Information:

Title

Dropout (the percentage of individuals who withdrew participation from treatment)

Description

Dropout will be compared in the two treatment groups to see if a certain intervention enhances compliance with treatment.

Time Frame

Month 6/ end-treatment assessment

Title

Treatment satisfaction scores as measured with the Client Satisfaction Questionnaire (CSQ)

Description

Treatment satisfaction is measured at end-treatment with CSQ. The CSQ rates effectiveness of, and satisfaction with services received.

Time Frame

Month 6/ end-treatment assessment

Title

Relationship satisfaction as measured with the Dyadic Adjustment Scale (DAS) and DAS-4

Description

Extent to which someone is happy in his or her relationship.

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.

Other Pre-specified Outcome Measures:

Title

Cost effectiveness ratio (is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment)

Description

The cost effectiveness ratio will be calculated using utilization data from the McKnight Follow-up of Eating Disorders (MFED).

Time Frame

Cost effectiveness is measured at each time point from 3 month follow-up to 12 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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. Exclusion Criteria 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. 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia Bulik, PhD

Organizational Affiliation

UNC Chapel Hill Department of Psychiatry

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Donald Baucom, PhD

Organizational Affiliation

UNC Chapel Hill Department of Psychology

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Center of Excellence for Eating Disorders

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Learn more about this trial

UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

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