Uniting Couples in the Treatment of Binge-Eating Disorder (UNITE)

University of North Carolina (UNC)

Status: Completed

Conditions: Binge-Eating Disorder

Treatments: Behavioral: UNITE; Behavioral: CBT-E

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03784820

1R34MH113681-01A1 (U.S. NIH Grant/Contract)

18-1379

Details and patient eligibility

About

The purpose of this study is to test the feasibility, acceptability, and preliminary effectiveness of a novel couple-based intervention for binge-eating disorder (BED) relative to an established evidence-based individual treatment (cognitive-behavioral therapy-enhanced; CBT-E) in a community clinic setting.

Full description

Clinicians' options for BED treatment are inadequate. Treatments for BED have demonstrated efficacy in controlled settings with specialist therapists and expert supervision, but much less in known about the effectiveness of BED interventions and whether the transition of evidence-based treatments to the community results in poorer outcomes. UNITE activates a key resource by incorporating an important part of the patient's social environment (the partner) into treatment. The investigators hypothesize that UNITE will show preliminary evidence of being superior to CBT-E in achieving binge abstinence via engaging ED-related relationship targets, including improved (a) communication around the disorder, (b) disorder-specific interpersonal problem-solving/ behavioral change skills, and (c) partner-assisted emotion regulation. The investigators will assess targeted relationship domains with observational and speech prosody measures during clinic interactions and self-reports reflecting experiences outside the clinic. Because the couple is learning how to work together to address BED, the investigators hypothesize that maintenance of gains will show evidence consistent with superiority in UNITE.

Enrollment: 44 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• current Diagnostic and Statistic Manual (DSM-5) criteria for binge-eating disorder (patient only)
• at least 18 years of age
• English speaking and able to read
• in a committed relationship for at least 6 months regardless of sexual orientation
• live with partner (or are interact with each other daily)
• partner willingness to participate in treatment
• able to travel to Chapel Hill, North Carolina weekly for treatment

Exclusion criteria

• alcohol or drug dependence in the past year
• current anorexia nervosa
• current significant suicidal ideation with active suicidal intent
• severe depression that would seriously interfere with functional capacity
• 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 reported levels of physical violence from either partner
• unwillingness to forgo non-protocol concurrent couple therapy or individual therapy (patient only)
• previously participated in the UNITE pilot trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

UNITE

Experimental group

Description:

UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.

Treatment:

Behavioral: UNITE

CBT-E

Active Comparator group

Description:

CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.

Treatment:

Behavioral: CBT-E