Uniting Couples in the Treatment of Binge-Eating Disorder

NCT03784820 | Completed Results DMC

• 2 other identifiers: 18-13791R34MH113681-01A1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Keywords

Binge-Eating Disorder; Eating disorders; Couple therapy; CBT

Outcome Measures

Primary Outcomes (1)

• Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence

  Binge-eating abstinence is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) and is the number of participants across study time points achieving abstinence from objective binge eating over the past 28 days. The EDE-Q measure replaces the measure in the protocol to capture a month of abstinence. The weekly binge measure was unsuitable upon review of the data because the 4 times weekly measures did not capture an exact 4-week time frame because of therapy scheduling irregularities, as verified by date-stamps of measure completion. Also, the weekly binge measure captured the past 7 days and was administered every session and once at other timepoints.

  Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)

Secondary Outcomes (15)

• Mean Binge-eating Frequency in Modified Intent-to-Treat Patients

  Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)

• Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients

  Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)

• Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients

  Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)

• Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients

  Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)

• Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners

  Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)

Other Outcomes (3)

• Couple Communication Measured by Observational Coding of Recorded Couple Conversations

  From Pre-treatment through Follow-up

• Couple Interpersonal Problem-solving/Behavior Change Skills Measured by Observational Coding of a Recorded Couple Conversation

  From Pre-treatment through Follow-up

• Partner-assisted Emotion Regulation Assessed With Vocally Encoded Emotional Arousal

  From Pre-treatment through Follow-up

Study Arms (2)

UNITE

EXPERIMENTAL

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

Behavioral: UNITE

CBT-E

ACTIVE COMPARATOR

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.

Behavioral: CBT-E

Interventions

UNITE 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.

UNITE

CBT-E 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).

CBT-E

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Due to COVID-related issues, the recruitment target was not reached.

Results Point of Contact

• Title: Hunna Watson, PhD
• Organization: University of North Carolina at Chapel Hill

hunna_watson@med.unc.edu

984-974-5217

Study Officials

• Cynthia Bulik, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Donald Baucom, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Model Details: Participants will be randomized to either couple therapy (UNITE) or individual therapy (CBT-E) for binge-eating disorder and will receive 16 1-hour sessions of the respective treatment. All study hypotheses will be tested using recommended Intent-To-Treat (ITT) methods. Differential treatment effects in individual functioning variables will be tested using 2 (time) x 2 (treatment) mixed-effect ANOVAs for binge-purge frequency and eating disorder outcomes and 2 (partner) x 3 (time) x 2 (treatment) mixed-effect ANOVAs for psychological outcomes. (Some variables will have 4 time points). Differential treatment effects in target relationship variables will be tested using 2 (partner) x 2 (time) x 2 (treatment) mixed-effect ANOVAs for all outcomes except vocally encoded emotional arousal. Differential treatment effects of vocally encoded emotional arousal will be tested using repeated-measures Actor Partner Interdependence Models (RM-APIMS).

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 24, 2018
• Study Start: January 9, 2019
• Primary Completion: March 5, 2022
• Study Completion: March 5, 2022
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data as described above will be made available 12 months after publication of the primary outcome paper.
• Access Criteria: IRB approval for secondary data analysis, an executed data sharing agreement with UNC-CH and approval by principal investigators.

Locations

US (1)