UCAN2: Uniting Couples in the Treatment of Anorexia Nervosa

NCT01740752 | Completed DMC

• 2 other identifiers: 11-19901R01MH093615-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Month 6/ end-treatment assessment

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

  Month 6/ end-treatment assessment

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

  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 Outcomes (1)

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

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

Study Arms (2)

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).

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.

Behavioral: CBT

Interventions

UCAN+CBT BEHAVIORAL

weekly manualized couple therapy plus weekly manualized individual CBT

Also known as: CBCT

UCAN+CBT

CBT BEHAVIORAL

weekly manualized higher "dose" of individual CBT

CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UNC Center of Excellence for Eating Disorders

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia 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: November 8, 2012
• First Posted: December 4, 2012
• Study Start: July 1, 2012
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (1)