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

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ClinicalTrials.gov Identifier: NCT03784820
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Utah
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Behavioral: UNITE Behavioral: CBT-E Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Relationship Domains in Community-Based Treatment of Binge-Eating Disorder
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: UNITE
UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.
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.

Active Comparator: 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.
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).




Primary Outcome Measures :
  1. Binge-eating abstinence rate [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    Binge-eating abstinence rate is measured as the percentage of participants across study time points achieving abstinence from binge eating. Measured using Binge-Eating Frequency, a 1-item self-report scale assessing the frequency of binge-eating episodes in the previous 7 days, range 0-no upper limit. Higher values indicate less severe pathology, with abstinence as the treatment outcome and follow-up goal. Last 4 weekly measures before assessment point are combined to yield binge abstinence in past 28 days.


Secondary Outcome Measures :
  1. Binge-eating frequency [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    Binge-eating frequency is measured using Binge-Eating Frequency, a 1-item self-report scale assessing the frequency of binge-eating episodes in the previous 7 days. Range is 0-no upper limit, with higher frequency indicative of more severe pathology. Last 4 weekly measures before assessment point are combined to yield binge frequency in past 28 days.

  2. Eating disorder symptomatology using the Eating Disorder Examination-Questionnaire (EDE-Q) [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    Eating disorder symptomology is measured using the Eating Disorder Examination-Questionnaire (EDE-Q). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).

  3. Binge-eating severity using the Binge-Eating Scale (BES) [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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.

  4. Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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.

  5. Depressive symptoms assessed with the Beck-Depression Inventory-II (BDI-II) Total score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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. Both patients and partners complete.

  6. Anxiety symptoms assessed with the Beck-Anxiety Inventory-II (BAI) Total score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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. Both patients and partners complete.

  7. Patient emotion regulation assessed with the Difficulties in Emotion Regulation Scale (DERS) Total Score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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.

  8. Partner emotion regulation assessed with the difficulties in Emotion Regulation Scale-Partner Version (DERS-Partner) Total Score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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. Item responses range from 1 to 5 with a total score range of 8 to 40. Higher scores indicate more (perceived) difficulties in one's partner's emotion regulation.

  9. Relationship adjustment assessed with the Dyadic Adjustment Scale (DAS-32) Total Score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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. Both patients and partners complete this measure.

  10. Relationship adjustment assessed with the Dyadic Adjustment Scale-Short Form (DAS-4) Total Score [ Time Frame: Weekly (during active treatment) ]
    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. Both patients and partners complete this measure.

  11. Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    The Communication Patterns Questionnaire-Short Form (modified for Binge-Eating Disorder) is a 13-item self-report scale that assesses how the couple communicates about binge-eating when the issue arises and when discussing the issue. Item responses range from 1 to 9, with a total sum score range of 13 to 117. The two subscales measured are Demand/Withdraw behaviors and Positive Interactions/Constructive Communication, with higher (subscale) sum scores indicating more of those types of behaviors, respectively. Patients and partners complete this scale

  12. Eating Disorders Quality of Life Questionnaire (EDQOL) Total Score [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    The Eating Disorders 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.

  13. Couple communication measured by observational coding of recorded couple conversations [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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. Ratings will be based on the Couples Interaction Rating System (CIRS), a 19-item observational coding system that assesses communication behaviors, as well as the Social Support Interaction Rating System (SSIRS), an 18-item observational coding system that assesses affective expression and supportive behavior. All items of both systems will be rated by trained observers on a 9-point Likert scale. Items from the two systems will be combined to create positivity (3 items, range 3-27) and negativity (7 items, range 7-63) subscales based on well-accepted combined scoring. Higher scores indicate greater positivity or negativity respectively.

  14. Couple interpersonal problem-solving/behavior change skills measured by observational coding of a recorded couple conversation [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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. Ratings will be based on the Couples Interaction Rating System (CIRS), a 19-item observational coding system that assesses communication behaviors, as well as the Social Support Interaction Rating System (SSIRS), an 18-item observational coding system that assesses affective expression and supportive behavior. All items of both systems will be rated by trained observers on a 9-point Likert scale. Items from the two systems will be combined to create the problem-solving subscale (4 items, range 4-36) based on well-accepted combined scoring. Higher scores indicate greater problem-solving capabilities.

  15. Partner-assisted emotion regulation assessed with Vocally encoded emotional arousal [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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.

  16. Problem-Solving/Communication Subscale of the Marital Satisfaction Inventory-Revised (MSI-R) [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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 will examine the problem-solving communication scale (PSC - 19 items), which assesses difficulty resolving minor differences, lack of problem-solving skills, and inability to discuss sensitive issues. PSC scores range from 0-19 with higher scores indicating poorer communication skill.

  17. Affective Communication Subscale of the Marital Satisfaction Inventory-Revised (MSI-R) [ Time Frame: From Pre-treatment through Post-treatment Month 6 ]
    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 will exclusively examine the affective communication scale (ASC - 13 items), which assesses general communication. ASC scores range from 0-13 with higher scores indicating poorer affective communication skills.

  18. Treatment acceptance using the Client Satisfaction Questionnaire-8 (CSQ-8) Total Score [ Time Frame: Post-treatment ]
    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). Both patients and partners complete this measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784820


Contacts
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Contact: Rachel Guerra (984) 974-3802 unite@unc.edu
Contact: Camden Matherne, PhD camden_matherne@med.unc.edu

Locations
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United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Rachel Guerra    984-974-3802    unite@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
University of Utah
Investigators
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Principal Investigator: Cynthia Bulik, PhD University of North Carolina, Chapel Hill
Principal Investigator: Donald Baucom, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Informed Consent Form  [PDF] November 28, 2018


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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03784820     History of Changes
Other Study ID Numbers: 18-1379
1R34MH113681-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (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 and approval by principal investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Binge-Eating Disorder
Eating disorders
Couple therapy
CBT

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms