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

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UNITE
CBT-E
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Binge-Eating Disorder, Eating disorders, Couple therapy, CBT

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UNITE

CBT-E

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 19, 2018
Last Updated
March 15, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH), University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03784820
Brief Title
Uniting Couples in the Treatment of Binge-Eating Disorder
Acronym
UNITE
Official Title
Targeting Relationship Domains in Community-Based Treatment of Binge-Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2019 (Actual)
Primary Completion Date
March 5, 2022 (Actual)
Study Completion Date
March 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Mental Health (NIMH), University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder
Keywords
Binge-Eating Disorder, Eating disorders, Couple therapy, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UNITE
Arm Type
Experimental
Arm Description
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
Arm Title
CBT-E
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
UNITE
Intervention Description
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
Intervention Name(s)
CBT-E
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence
Description
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.
Time Frame
Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)
Secondary Outcome Measure Information:
Title
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
Description
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.
Time Frame
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)
Title
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
Description
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).
Time Frame
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)
Title
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
Description
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.
Time Frame
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)
Title
Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients
Description
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.
Time Frame
Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)
Title
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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
Time Frame
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)
Title
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
Description
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.
Time Frame
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)
Title
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
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)
Title
Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners
Description
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.
Time Frame
Post (after 16 weekly treatment sessions) (T2)
Other Pre-specified Outcome Measures:
Title
Couple Communication Measured by Observational Coding of Recorded Couple Conversations
Description
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.
Time Frame
From Pre-treatment through Follow-up
Title
Couple Interpersonal Problem-solving/Behavior Change Skills Measured by Observational Coding of a Recorded Couple Conversation
Description
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).
Time Frame
From Pre-treatment through Follow-up
Title
Partner-assisted Emotion Regulation Assessed With Vocally Encoded Emotional Arousal
Description
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.
Time Frame
From Pre-treatment through Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Bulik, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald Baucom, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It is our intention to make data available to the general scientific community at the conclusion of the clinical trial. Given the fact that most of the entities involved in this application must be HIPAA compliant, deidentification of data along HIPAA guidelines will guide the development of the final database to be shared. The current plan would be to have the dataset available via the web through postings of the information on the Academy for Eating Disorders, the Eating Disorders Research Society, and the Association for Behavioral and Cognitive Therapy websites. Data will be provided in SAS and SPSS formats. The investigators will provide a detailed protocol and a code book. The availability of the de-identified data on these web pages would be announced in journals and publications of interest to clinicians and researchers in the areas of eating disorders, couple therapy, and cognitive-behavioral therapy.
IPD Sharing Time Frame
Data as described above will be made available 12 months after publication of the primary outcome paper.
IPD Sharing Access Criteria
IRB approval for secondary data analysis, an executed data sharing agreement with UNC-CH and approval by principal investigators.

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Uniting Couples in the Treatment of Binge-Eating Disorder

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