Uniting Couples in the Treatment of Binge-Eating Disorder

Not Applicable

Completed

• Conditions: Binge-Eating Disorder
• Interventions: Behavioral: CBT-E; Behavioral: UNITE

• Registration Number: NCT03784820
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-24
• Study Start: 2019-01-09
• Status Verified: 2022-03
• Primary Completion: 2022-03-05
• Study Completion: 2022-03-05
• Results First Submitted: 2023-01-19
• Results First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Results First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence	Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Binge-eating frequency is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) number of objective binge episodes item which spans the past 28 days. Range is 0-no upper limit, with higher frequency indicative of more severe pathology. The EDE-Q measure replaces the originally planned measure in the protocol.
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)	The Binge-Eating Scale is a 16-item self-report scale that assesses behavioral, affective, and attitudinal components of the subject experience of binge-eating. Item responses range from 0 to 3, with a total score range of 0 to 48. Higher sum scores indicate greater binge-eating severity and associated emotional distress.
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)	The Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The total score range is 0 to 40. Higher scores indicate greater severity of compulsive behaviors and preoccupations related to binge-eating.
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)	The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures of depressive symptoms. It includes 21 self-report items. Total scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms
Mean Difficulties in Emotion Regulation Scale (DERS) 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)	The Difficulties in Emotion Regulation Scale is a 36-item self-report scale that assesses emotion regulation. Item responses range from 1 to 5, with a total score range of 36 to 180. Higher scores indicate more difficulties in emotion regulation.
Mean Partner Difficulties in Emotion Regulation Scale (DERS) 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)	The partner version of the Difficulties in Emotion Regulation Scale is an 8-item modified version of the DERS. It is a self-report scale that assesses perceptions of one's partner's emotion regulation ability and skills. Three items from the Impulse Control Difficulties (ICD) and 5 items from the Emotion Regulation Strategies (ERS) subscale were administered. Item responses range from 1 to 5 and the total score is the sum of the items. The total score range is 8 to 40. Higher scores indicate more (perceived) difficulties in one's partner's emotion regulation.
Mean Dyadic Adjustment Scale (DAS-32) 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)	The Dyadic Adjustment Scale is a 32-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 151. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) 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)	This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study, the investigators examined the Problem-Solving Communication scale (PSC - 19 items), which measures the inability to resolve differences in the relationship. PSC scores range from 0-19 with higher scores indicating poorer problem-solving communication skills.
Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners	Post (after 16 weekly treatment sessions) (T2)	Treatment acceptability was measured with the 8-item Client Satisfaction Questionnaire, a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate greater treatment satisfaction (acceptability). An independent samples t test was conducted.
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)	Eating disorder symptomatology is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) global score. This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. The global score is obtained by summing the four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) and then dividing this sum by the number of subscales (i.e., four). The global score range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) 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)	The Eating Disorder Quality of Life questionnaire is a self-report 25-item health-related quality of life questionnaire that measures the perceived extent to which the eating disorder affects the subject's quality of life in different domains. Item responses range from 0 to 4, with a possible score range of 0 to 100. Higher scores indicate lower quality of life.
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) 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)	This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study the investigators examined the 13-item Affective Communication scale (ACS), which assesses general communication. ACS scores range from 0-13 with higher scores indicating poorer affective communication skills.
Mean Dyadic Adjustment Scale-Short Form (DAS-4) 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)	The Dyadic Adjustment Scale-Short Form (DAS-4) is a 4-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 21. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores 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)	The Communication Patterns Questionnaire-Short Form (modified for Binge-Eating Disorder) assesses how the couple communicates about binge-eating when the issue arises and when discussing the issue. Item responses range from 1 to 9. The three subscales measured are Self Demand/Partner Withdraw (3 items), Partner Demand/Self Withdraw (3 items), and Constructive Communication (3 items). The Demand/Withdraw subscales were combined and have a score range of 6 to 54 and the Constructive Communication subscale has a score range of 3 to 27. Higher (subscale) sum scores indicate more of those types of behaviors, respectively; high scores on the Demand/Withdraw and low scores on the Constructive Communication subscale are worse, respectively.
Mean Beck Anxiety Inventory-II (BAI-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)	The Beck-Anxiety Inventory-II (BAI) is a self-report measure that assesses different aspects of the anxiety experience (e.g., physiological, cognitive, behavioral). The total score ranges from 0 to 63 with higher scores indicative of greater anxiety symptoms.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States