Uniting Couples in the Treatment of Binge-Eating Disorder

NCT ID: NCT03784820

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2022-03-05

Brief Summary

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.

Detailed 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.

Conditions

Binge-Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

UNITE

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

Group Type: EXPERIMENTAL

UNITE

Intervention Type: BEHAVIORAL

UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.

CBT-E

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.

Group Type: ACTIVE_COMPARATOR

CBT-E

Intervention Type: BEHAVIORAL

CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).

Interventions

UNITE

UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.

Intervention Type: BEHAVIORAL

CBT-E

CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Bulik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Donald Baucom, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R34MH113681-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-1379

Identifier Type: -

Identifier Source: org_study_id