Uniting Couples in the Treatment of Binge-Eating Disorder

Binge-Eating Disorder Clinical Trial

— UNITE  

Official title:

Targeting Relationship Domains in Community-Based Treatment of Binge-Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784820
• Other study ID #: 18-1379
• Secondary ID: 1R34MH113681-01A
• Status: Completed
• Phase: N/A
• Start date: January 9, 2019
• Est. completion date: March 5, 2022

Study information

• Verified date: March 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 5, 2022
• Est. primary completion date: March 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

Behavioral:
• 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.
• 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).

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Couple Communication Measured by Observational Coding of Recorded Couple Conversations	Couple communication will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS), observational coding systems that assess communication behaviors, affective expression, and supportive behavior.	From Pre-treatment through Follow-up
Other	Couple Interpersonal Problem-solving/Behavior Change Skills Measured by Observational Coding of a Recorded Couple Conversation	Couple interpersonal problem-solving/behavior change skills will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to problem-solve on some aspect of the patient's binge-eating disorder and attempt to agree upon behavioral changes that they will make. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS).	From Pre-treatment through Follow-up
Other	Partner-assisted Emotion Regulation Assessed With Vocally Encoded Emotional Arousal	Two 10-minute video-taped interactions during which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder and to problem-solve on some aspect of the patient's binge-eating disorder, respectively. Vocally encoded emotional arousal will be measured using fundamental frequency (f0) from patients' and partners' speech. F0 is a spectral analysis-based measure of speech prosody that refers to the lowest frequency harmonic of the speech sound wave, created by the opening and closing of the vocal folds while air flows outward from the lungs during speech production. Emotion regulation is indicated by one's ability to return to a stable set-point after being perturbed from that set-point. Stronger regulation is indicated by a faster return to the set-point. The range of fundamental frequency for speech in adult men and women is approximately 75-300hz.	From Pre-treatment through Follow-up
Primary	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	Mean Binge-eating Frequency in Modified Intent-to-Treat Patients	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.	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)
Secondary	Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients	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).	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)
Secondary	Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients	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.	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)
Secondary	Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients	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.	Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)
Secondary	Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners	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	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)
Secondary	Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients	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.	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)
Secondary	Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners	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.	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)
Secondary	Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners	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.	Post (after 16 weekly treatment sessions) (T2)