Targeting Relationship Domains in Community-Based Treatment of Binge-Eating Disorder
Phase: NA
Conditions: Binge-Eating Disorder
Sponsor: University of North Carolina, Chapel Hill

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Complete Title: Targeting Relationship Domains in Community-Based Treatment of Binge-Eating 
Disorder 
 
Short Title: Uniting Couples in the Treatment of Binge-Eating Disorder (UNITE) 
Sponsor: National Institute of Mental Health 
NCT03784820  
Protocol Date: 08/29/18 
Amendment 1 Date: 
Amendment 2 Date:  
Amendment 3 Date: 
Amendment 4 Date:  
 
Sponsor 
National Institute of Mental Health 
6001 Executive Boulevard 
Bethesda, MD, 20892 
USA 
Study Principal Investigator 
Cynthia Bulik, Ph.D. 
101 Manning Drive 
CB# 7160 
Chapel Hill, NC, 27599-7160 
Phone 919-974-9217 
email: cynthia_bulik@med.unc.edu 
 
 
 
 
PROTOCOL TITLE:  Targeting Relationship Domains in Community-Based Treatment of Binge-Eating 
Disorder  
Short Title:  
Uniting Couples in the Treatment of Binge-Eating Disorder (UNITE)  
Lead Investigator: 
Cynthia Bulik, Ph.D. 
 University of North Carolina at Chapel Hill 
Protocol Version: 1.0  
Version Date: December 17, 2022 

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I confirm that I have read this protocol and understand it.    
Principal Investigator Name:   
 
Cynthia Bulik  
Principal Investigator Signature:  
 
Date:   
 
 
 
 
8/29/18 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation
Definition
BED
Binge-eating disorder 
NIMH
National Institute of Mental Health
DSM
Diagnostic and Statistical Manual of Mental Disorders
NIMH
National Institute of Mental Health 
ED
Eating disorder(s)
UNITE 
Uniting Couples in the Treatment of Eating Disorders (a couple-based intervention for 
Binge-eating disorder)
CBT-E 
Cognitive-Behavioral Therapy – Enhanced (an individual-based psychological treatment 
for eating disorders)
CBCT
Cognitive-Behavioral Couple Therapy 
PCP
Primary Care Provider
CBT
Cognitive-Behavioral Therapy 
PI
Principal Investigator(s)
RC
Research Coordinator
UNC
University of North Carolina 
IRB
Institutional Review Board
DSMG
Data and Safety Monitoring Group 
MLM
Multi-level modeling
AN
Anorexia nervosa 
BN
Bulimia nervosa
EDE-Q
Eating Disorder Examination-Questionnaire
BES
Binge Eating Scale 
YBOCS-BE 
Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating
BE Frequency
Binge Eating Frequency 
SCID
Structured Clinical Interview for DSM-IV
BDI-II
Beck Depression Inventory-II
BAI 
Beck Anxiety Scale
DERS
Difficulties in Emotion Regulation Scale
DERS-Partner 
Difficulties in Emotion Regulation- Partner Version 
DAS 
Dyadic Adjustment Scale
DAS-4
Dyadic Adjustment Scale-4 Item Version 
CPQ-SF 
Communication Patterns Questionnaire-Short Form
R-BISF
Brief Index of Sexual Functioning, Revised
MSI-R (AFC, 
PSC)
Marital Satisfaction Inventory-Revised (Affective Communication, Problem-Solving 
Communication Subscales)
EDQOL
Eating Disorders Quality of Life 
CSQ
Client Satisfaction Questionnaire
 
 
 

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     PROTOCOL SYNOPSIS 
Study Title 
Targeting Relationship Domains in Community-Based 
Treatment of Binge-Eating Disorder 
Funder 
NIMH 
Study Rationale 
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 of 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 Objective(s) 
Primary  
● 
To compare the effectiveness of UNITE versus CBT-E in 
achieving abstinence from binge-eating. 
Secondary 
● 
To compare the effectiveness of UNITE versus individual CBT-
E in decreasing ED-related psychopathology, depression, and 
anxiety. 
● 
To compare target relationship domains in patients and 
partners. 
● 
To compare treatment satisfaction and ED-related quality of life 
in UNITE versus CBT-E 
Study Design 
 
38 couples will be enrolled over 18 months (to aim for 34 couples 
who complete the intervention). Each couple will be randomly 
assigned to UNITE or CBT-E and will undergo 16 weeks of study 
treatment. Preliminary efficacy (e.g., changes in binge-eating 
frequency, depression, anxiety, and relationship functioning) of 
UNITE will be assessed in comparison to the control group (CBT-
E). Treatment gains will be assessed including observational and 
self-report measures. 
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
1. Subjects age 18 – 99 
2. Current DSM-5 criteria for BED (one partner per couple) 
3. English speaking and able to read 
4. In a committed relationship for at least 6 months (regardless 
of sexual orientation) 

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5. Live with partner (or interact with each other daily) 
6. Partner willingness to participate in treatment 
7. Able to travel to Chapel Hill, NC weekly for treatment (N.B. 
Changed in 3/20 to “in North Carolina” due to pandemic) 
Exclusion Criteria 
1. Alcohol or drug dependence in the past year 
2. Current anorexia nervosa; current bulimia nervosa 
3. Current significant suicidal ideation with active suicidal 
intent 
4. Severe depression that would seriously interfere with 
functional capacity 
5. Developmental disability that would impair the ability to 
benefit from the intervention 
6. Any psychosis, schizophrenia, or bipolar I disorder, unless 
stably remitted on maintenance therapy for at least 1 year 
7. Moderate to high reported levels of physical violence from 
either partner 
8. Unwillingness to forgo non-protocol concurrent couple 
therapy 
9. Previously participated in the UNITE pilot trial 
Number of Subjects  
76 (38 couples) 
Study Duration 
Each subject’s participation will last approximately 20-30 hours 
over 10 months. The entire study is expected to last two years. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Screening: After consenting to participate and completing an 
initial phone screening, potential participants will be asked to 
complete a pre-treatment assessment consisting of electronic 
questionnaires and an in-person interview in order to determine 
eligibility for the study. These assessments will ask questions about 
a range of relationship concerns and interaction patterns as well as 
eating behaviors. The participant with BED in each couple must 
provide written certification from their PCP that their health status is 
suitable for this study. After determining eligibility, patients will be 
randomized to either UNITE or CBT-E and receive 16 
approximately one-hour sessions of the respective treatment. 
(2) Intervention:  
● UNITE is a manualized CBCT intervention that engages the 
couple to address the core psychopathology of BED and 
targets improved: 
o Communication around the ED 
o Interpersonal problem-solving and behavioral 
change skills 
o Partner-assisted emotion regulation 
● CBT-E is a manualized CBT intervention for ED with four 
stages of treatment: 
o Psychoeducation and symptom self-monitoring 
o Review progress and formulate plans for future 

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o Reducing ED behaviors and improve mood 
tolerance 
o Maintaining progress and minimizing relapse risk 
(3) Follow-Up: Participants will complete follow-up assessments: 
● at the end of treatment 
● 3 months after the completion of treatment 
● 6 months after the completion of treatment 
Efficacy Evaluations 
Recruitment, enrollment, retention, and follow-up targets met. 
 
Safety Evaluations 
The clinical status of all participants will be monitored closely by the 
study team. If information about a participant is generated that 
warrants concern (such as participant suicidality or danger to self or 
others), the research team will follow an established safety protocol 
to assess for immediate participant danger or safety. Participants 
will be provided with appropriate crisis resources if needed at the 
time of assessment. If concerns are identified that require additional 
support (for either the patient or the partner), the research team will 
work to find the participant an appropriate professional referral from 
an internal referral list of therapists, psychiatrists, nutritionists, and 
other mental health professionals.  
Outcomes 
Primary outcome: Eating Disorder Examination-Questionnaire 
(EDE-Q) abstinence from binge eating (Fairburn & Beglin, 1994).  
 
Secondary outcomes will include ED symptoms, depression and 
anxiety, couple-based measures, treatment satisfaction, and quality 
of life. ED symptoms will be measured with the Eating Disorder 
Examination-Questionnaire (EDE-Q; 28 items) binge frequency and 
global score (Fairburn & Beglin, 1994), the Binge Eating Scale 
(BES; 16 items) which measures binge eating severity (Gormally et 
al., 1982), and the Yale-Brown Obsessive Compulsive Scale 
Modified for Binge Eating (Y-BOCS-BE; 10 items) which measures 
the obsessiveness of binge-eating thoughts and compulsiveness of 
binge-eating behaviors (Deal et al., 2015). Beck Depression 
Inventory-II (BDI-II; 21 items) and Beck Anxiety Inventory (BAI; 21 
items) will measure severity of current depressive and anxiety 
symptoms, respectively (Beck et al., 1988; Beck et al., 1996). 
Difficulties in Emotion Regulation Scale (DERS; 36-item) and the 
partner version (DERS-Partner; 8 items) will measure emotion 
regulation in oneself and one’s partner, respectively (Gratz & 
Roemer, 2004). Dyadic Adjustment Scale (DAS; 32 items) and 
DAS-4 (4 items) will measure relationship satisfaction. 
Communication Patterns Questionnaire-Short Form (CPQ-SF; 12 
items (Christensen & Heavey, 1990) modified for BED has two 
scores that will be calculated to assess how the couple 
communicates about the ED. These are a total score made up of 
the Self Demand/Partner Withdraw and Partner Demand/Self 
Withdraw subscales (6 items) and the Constructive Communication 
subscale (3 items). Marital Satisfaction Inventory (MSI-R; 32 items) 
affective communication (AFC) and problem-solving/communication 
(PSC) subscales will be used (Snyder, 1997). Treatment 
satisfaction will be measured with the Client Satisfaction 
Questionnaire (CSQ; 18 items). (Nguyen et al., 1983). Eating 

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Disorders Quality of Life (EDQOL; 26 items) will measure the extent 
to which the ED affects quality of life (Engel, 2003). ED-related 
measures will be given to patients only and all other measures will 
be given to patients and partners.   
Statistical and Analytic 
Plan 
Intent-to-treat or modified intent-to-treat, if appropriate, will 
comprise the primary approach. Differential treatment effects will be 
analyzed with multilevel mixed-effects models with fixed effects and 
interactions for Time, Treatment, and (where appropriate) 
Participant Status (i.e., patients/partners), and with random effects 
to address clustering.
Data and Safety 
Monitoring Plan 
The DSMG will be responsible for data quality management and 
ongoing assessment of participant safety. 
 
1 
BACKGROUND AND RATIONALE 
1.1 
Introduction 
Clinicians’ options for EDs (ED) treatment are inadequate. EDs challenge caregivers and strain 
relationships (Van den Broucke & Vandereycken, 1988; Van den Broucke et al., 1994, 1995, 1995; 
Whisman et al., 2012). Partners are typically excluded from treatment. Family involvement improves 
outcomes in youth (le Grange et al., 2010) and in adults with anorexia nervosa (AN) (Baucom et al., 
2017). Engaging partners improves weight gain in AN, reduces high drop out in AN (Baucom et al., 
2017) and binge-eating disorder (BED) (Runfola et al., 2018), and may lead to greater binge-eating 
abstinence (Runfola et al., 2018). As BED awareness and treatment demand increases post DSM-5, 
the field will benefit from scalable interventions.  
- Name and Description of Intervention: The experimental treatment, UNITE, is a manualized 
cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core 
psychopathology of BED. It 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. 
The 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. It 
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 over-evaluation of shape and 
weight); and the fourth stage (maintaining progress and minimizing relapse risk). 
 
1.2 
Non-Clinical and Clinical Study Findings 
- Potential Benefits: This is a treatment research study in which all patients enrolled will receive an 
intervention for BED (regardless of the treatment group to which they are randomized). Although the 
investigators cannot guarantee that patients will derive any benefit from the study, the likelihood is fairly 
high that patients will benefit to some degree from the study. Results of this study could enhance 
treatment of BED. If implementation of the couple program is feasible and efficacious, couple treatment 
may show promise in increasing treatment response rates and maintaining engagement after formal 
treatment. Training for a couple-based approach to the treatment of BED could also then be 
implemented in other non-specialty settings, thus increasing patient access to care. 

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- Risk /Benefit Assessment: Participants may find participation in clinical interviews or the videotaped 
assessments to be unpleasant or distressing. Similarly, any psychotherapeutic intervention may be 
associated with discomfort consequent to discussion of painful symptoms or problems. Some 
participants may find the couple format uncomfortable. A number of steps will be taken to protect 
participants against possible risks. All study personnel will be trained to be sensitive to participants’ 
concerns and will make it clear to participants that participation in the study is voluntary and that they 
may withdraw from the study at any time. Participants will be directed to alert study personnel if there is 
a change in their psychological condition. Strict confidentiality will be maintained with any use of 
participants’ medical records or claim files in accordance with federal, state, and local policies. 
Research data will be maintained in separate charts and identified by participant number only. Clinical 
supervision of UNITE and CBT-E study treatment will each be conducted by a licensed psychologist 
with a one-hour weekly group supervision meeting. Thus, through initial training and weekly 
supervision, the investigators will provide supervision commensurate with the practice of the community 
clinic. 
 
1.3 
Relevant Literature and Data 
Treatments for BED and bulimia nervosa (BN) have demonstrated efficacy in controlled settings with 
specialist therapists and expert supervision (Brownley et al., 2016; Shapiro et al., 2007). Much less is 
known about the effectiveness of BED/BN interventions and whether the transition of evidence-based 
treatments to the community results in poorer outcomes. One strategy to bolster the effectiveness of 
BED/BN treatment in real world conditions is to activate resources in the patient’s environment 
(Grawe, 2007). Including partners in treatment is one such resource and is defensible, as 22-46% of 
BN patients (Carter et al., 2003; Ghaderi, 2006; Poulsen et al., 2014) and 60-77% of BED patients 
(Safer & Jo, 2010; Schlup et al., 2010) are married or co-habiting, comparable to healthy controls 
(Maxwell et al., 2011). Partners are eager to help yet unsure what to do (Kirby et al., 2015). 
Relationships can also be a source of stress, as BED/BN patients report higher levels of relationship 
distress, negative interactions, and poorer communication than those with other psychiatric disorders 
(Van den Broucke & Vandereycken, 1988; Van den Broucke et al., 1994, 1995, 1995; Whisman et al., 
2012). The transdiagnostic theory of EDs highlights adverse interpersonal environments as illness-
maintaining factors (Fairburn et al., 2003), and interpersonal theory targets interpersonal stressors as 
binge/purge triggers via their contribution to negative affect (Arcelus et al., 2013). Patients also cite 
interpersonal stressors as common binge/purge triggers, as confirmed by ecological momentary 
sampling (Goldschmidt et al., 2014; Hilbert et al., 2011). Including a partner in treatment facilitates 
transformation of the relationship from a stressor into an agent of positive change.  
The investigators have incorporated partners in the treatment of adult psychiatric disorders, using 
adaptations of cognitive-behavioral couple therapy (CBCT) (Abramowitz et al., 2013; Baucom et al., 
2017; Baucom et al., 1998; Sher  et al., 1990). The investigators demonstrated initial efficacy of our 
couple-based ED treatments in a university hospital specialist setting (Baucom et al., 2017; Bulik et al., 
2011; Kirby et al., 2015). The investigators developed a CBCT intervention for BED/BN (UNiting 
couples In the Treatment of Eating disorders [UNITE]). Here the investigators test the preliminary 
comparative effectiveness of UNITE versus individual CBT-enhanced (CBT-E) (a transdiagnostic 
treatment for EDs) in a small randomized controlled trial (RCT) of 28 couples in a community clinic. 
Because 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/purge 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. 
Targeted relationship domains will be assessed with observational and speech prosody measures 
during clinic interactions and self-reports reflecting experiences outside of the clinic. Because the 

9 
 
couple is learning how to work together to address BED/BN the maintenance of gains are hypothesized 
to show evidence consistent with superiority in UNITE.  
2 
STUDY OBJECTIVE  
 
2.1 
Primary Objective: The purpose of this study is to test the feasibility, acceptability, and preliminary 
effectiveness of a novel couple-based intervention for BED (UNITE) relative to an established 
evidence-based individual treatment (CBT-E) in a community clinic setting. 
 
3 
INVESTIGATIONAL PLAN  
 
3.1 
Study Design 
Type of design: Randomized controlled trial 
Brief overview of the study phases: see Protocol Synopsis “Study Phases” 
3.2 
Study Duration, Enrollment and Number of Subjects 
38 couples will be enrolled over 18 months (to aim for 34 couples who complete the intervention). Each 
couple will be randomized to either UNITE or CBT-E and will undergo 16 weeks of treatment, followed 
by follow-up assessments at the end of treatment and 3- and 6-months after the end of treatment. 
3.3 
Study Population: see Protocol Synopsis “Subject Population” 
 
4 
STUDY PROCEDURES 
4.1 
Screening/Baseline Visit procedures 
Pre-Treatment 
 
1. Patient and partner come in for pre-treatment visit, which includes the following: 
- Consent with both patient and partner 
- Videotaped couple interaction 
- Interviews 
- Self-report Questionnaires 
2. Eligibility is determined 
3. Couple is randomized to UNITE or CBT-E condition 
4. Therapist is assigned and notified 
 
Baseline (Pre-Treatment) 
o Consent 
o Background information  
 
Background Information (1 min).  This questionnaire asks questions about age, sex, 
race/ethnicity, socioeconomic status, and relationship history. 
o Couple Interaction 
 
Couple is recorded having two 10-minute conversations:  
 
For the first conversation (“sharing thoughts and feelings”) the couple is given the 
prompt: Please select an issue in your relationship related to [patient’s] eating 
disorder, sharing your thoughts and feelings with each other about this issue. 
Don’t attempt to resolve it, just let each other know what you think and feel. Try 
to select something that you view as being of a moderate level of concern or 
intensity.   
 
For the second conversation (“problem-solving”), the couple is given the prompt: 
I will again ask you to select an issue in your relationship related to [patient’s] 

10 
 
eating disorder, but this time you will discuss ways you could resolve or improve 
this issue. Try to select something that you view as being of a moderate level of 
concern or intensity. That is, don’t select something trivial, but also don’t select 
the most difficult concern that you have.” 
 
For each conversation, the interviewer may assist the couple in identifying a topic for 
conversation. Then, the interviewer leaves the room during the 10-minute recorded 
conversation. 
o Vitals (Patient, Partner) 
 
Self-reported height, weight, BMI  
o Questionnaire (Patient, Partner) 
 
ED100K, EDE-Q, BES, BE frequency, BDI-II, BAI, DERS, DERS-Partner, DAS, CPQ-
SF, R-BISF, CTS-2, MSI-R, EDQOL 
o Interview (Patient, Partner) 
 
Videotaped couple interaction 
 
MINI, YBOCS-BE 
 
4.2 
Intervention/Treatment procedures (by visits) 
 
Both UNITE and CBT-E have 16 treatment sessions 
Weekly questionnaires to be completed by the participants in treatment 
Weekly Questionnaires consist of binge eating frequency assessment, DAS-4  
For UNITE, Patient and Partner fill out questionnaires. For CBT-E, only Patient. 
Mid-treatment assessment after session 8 is completed 
End-treatment assessment after session 16 is completed 
 
Mid-Treatment (after Session 8) 
 
Vitals (Patient, Partner) 
o Self-reported height, weight, BMI 
 
Questionnaire (Patient, Partner) 
- 
EDE-Q, BES,  BE frequency, BDI-II, BAI, DERS, DERS-Partner, DAS, CPQ-SF, R-BISF, MSI-R, 
EDQOL 
 
Check BDI for suicidality 
 
YBOCS-BE Interview (Patient) 
Post-Treatment (after Session 16) 
o Couple Interaction 
o Vitals (Patient, Partner) 
 
Self-reported height, weight, BMI 
o Questionnaire (Patient, Partner) 
▪ 
CSQ, EDE-Q, BES,  BE frequency, BDI-II, BAI, DERS, DERS-Partner, DAS, CPQ-SF, 
R-BISF, MSI-R, EDQOL 
o YBOCS-BE Interview (Patient) 
o Therapist Feedback (Therapist) 
 
4.3 
Follow-up procedures (by visits) 
*N.B.: virtual after 3/20. 
 
3-Month Follow-Up 
o Vitals (Patient, Partner) 

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 
Height, weight, BMI, blood pressure, heart rate 
o Questionnaire (Patient, Partner) 
 
EDE-Q, BES,  BE frequency, BDI-II, BAI, DERS, DERS-Partner, DAS, CPQ-SF, R-BISF, 
MSI-R, EDQOL 
o $50 visa card upon completion 
 
6-Month Follow-Up 
o Vitals (Patient, Partner) 
 
Self-reported height, weight, BM 
o Questionnaire (Patient, Partner) 
 
EDE-Q, BES,  BE frequency, BDI-II, BAI, DERS, DERS-Partner, DAS, CPQ-SF, R-BISF, 
MSI-R, EDQOL 
o YBOCS-BE Interview (Patient) 
o $50 visa card upon completion 
 
 
4.4 
Subject Withdrawal procedures 
Decisions regarding study withdrawal will be made by the investigators. Factors to consider include: 
(a) physical deterioration or escalation of symptoms requiring prolonged hospitalization 
(b) couple separates and is no longer in a committed relationship.  
(c) significant risk of suicide in the judgment of the treatment provider 
(d) development or exacerbation of a severe comorbid psychiatric disorder, such as a psychotic 
disorder or severe major depressive disorder, making it unlikely that they would benefit from outpatient 
treatment. 
 
4.5 
Screen Failure procedures 
Participants who are ineligible for this study will be provided with treatment referral information. 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS   
5.1 
Efficacy Evaluation 
Preliminary efficacy (e.g. changes in binge-eating frequency, depression, 
anxiety, and relationship functioning) of UNITE will be assessed in comparison to the control group 
(CBT-E). Treatment gains will be assessed including observational and self-report measures. The 
primary outcome is abstinence from binge eating over the past 28 days measured with the EDE-Q. 
Secondary outcomes include EDE-Q binge frequency and global psychopathology, BES, Y-BOCS-BE, 
BDI-II, BAI, DERS, DERS-Partner, DAS, DAS-4, CPQ-SF, MSI-R (AFC and PSC), CSQ, and EDQOL. 
5.2 
Safety Evaluations 
Weekly reports from therapists to supervisors on therapy progress and from staff on assessments and 
follow-up visits. Discussed by investigators at weekly team meetings. 
 
STATISTICAL CONSIDERATIONS    
5.3 
Statistical Methods 
- 
Baseline Data. Sociodemographics and baseline clinical characteristics will be summarized with 
descriptive statistics. 
- 
Efficacy Analysis. Study hypotheses will be tested using intent-to-treat or modified intent-to-treat 
methods, as appropriate. For patient-only outcomes, differential treatment effects will be tested with 
multilevel mixed-effects models with fixed effects and two-way interactions for Time and Treatment 
and a random effect for Patient. For outcomes assessed in both patients and partners, differential 
treatment effects will be tested with multilevel mixed-effects models with fixed effects and two- and 

12 
 
three-way interactions for Time, Treatment, and Participant Status (i.e., Patient or Partners) and 
random effects for Participant and Couple. Linear, logistic, and Poisson distribution functions will be 
used to model outcome variables. Treatment satisfaction, assessed at post-treatment only, will be 
compared between patients in UNITE and CBT-E with linear regression.   
- 
Safety Analysis. Adverse events will be summarized as a numerator (total affected) and 
denominator (number at risk) for patients and partners in each treatment arm using the 
ClinicalTrials.gov categories of all-cause mortality, serious adverse events, and other (not including 
serious) adverse events.  
5.4 
Sample Size and Power 
While there is not universal agreement about the minimum number of higher-level groups required to 
produce stable estimates in multilevel models, Maas and Hox’s (2005) definitive simulation study of 
bias in higher level effects demonstrates that a sample size of 20 groups (which are couples in this 
case) is sufficient to produce unbiased estimates of standard errors. Thus, while the sample size of 38 
couples does not result in power to test all study hypotheses, the sample size of 38 couples is 
adequate to perform unbiased analyses using multilevel mixed-effects models. 
5.5 
Interim Analysis 
Problems with participant recruitment, dropouts, or data management would be most likely to trigger the 
need for stopping the protocol. However, adverse events also would be a possible reason as would a 
clear finding of superiority for one treatment arm prior to the completion of the protocol. It is unlikely that 
any new information will become available that would necessitate stopping the trial. It is possible that 
excessive study dropouts and missing data would limit the data analysis. The investigators have 
powered the study expecting dropouts. The investigators acknowledge that there may be situations that 
occur that might warrant stopping the trial that are not covered here. 
 
6 
STUDY INTERVENTION (intervention details) 
- 
Description: see Background and Rationale “Name and Description of Intervention” 
- 
Treatment Compliance and Adherence 
Given the substantial interruption to the trial due to the Covid-19 pandemic (i.e., initial couples 
receiving face-to-face care; some couples having a portion of treatment face to face and 
transitioning to virtual, other couples having fully virtual treatment) our adherence measures were 
limited to assurances by the supervisors (who reviewed audio-recordings of all sessions) that 
therapists were adhering to the treatments as laid forth in the manuals. As funding for personnel 
continued even when the trial was interrupted, adequate funds for extensive compliance/adherence 
assessments were not available. 
 
7 
STUDY INTERVENTION ADMINISTRATION  
- 
Randomization: The study statistician will write a computer program to perform a stratified random 
assignment to the initial two conditions on a 1:1 basis using a permuted block algorithm. 
 
8 
SAFETY MANAGEMENT 
-Adverse Event Monitoring and Reporting 
Any unanticipated problems, or adverse events, or new safety concerns will be promptly reported to the 
UNC IRB and discussed by the PIs and DSMG.  
-See Protocol Synopsis “Data and Safety Monitoring Plan” 
 
9 
DATA COLLECTION AND MANAGEMENT  
The DSMG will standardize data collection, management, and analysis, evaluate the progress of the 
study, and monitor participant safety and data quality. Privacy will be ensured for all participants in 
several ways. All potential participants will call the RC if interested in the study. Should potential 

13 
 
couples pass the telephone screening, they will be scheduled for an in-person interview, which will be 
conducted in a private room by one of the study personnel. During this interview, couples will be asked 
to complete measures pertaining to eating behavior and weight loss. They will be instructed that they 
are allowed to leave any answer blank if they do not want to complete the question. All participants and 
partners will be assigned a study number, which will be used in place of their name. The key linking 
study numbers to names will be kept in a locked filing cabinet and in a password protected excel file, 
only accessible to the PI. Participants will not be identified by name in any analysis or publication 
resulting from this study. Electronic files containing participant data will be password protected and 
stored on a secure server. Digital video and audio files of treatment sessions and assessments will be 
handled with extreme care, given that visual and audio information can identify participants. Audio and 
video recordings will be password protected, encrypted. The digital video recordings from the 
assessment sessions will be coded by trained research assistants who are well trained in the 
importance of participant confidentiality. Assessment sessions will be viewed only in confidential 
research settings where no one other than the coders, their trainers, and their supervisors can see the 
video monitor or hear the participants’ voices. Recordings of assessment interviews and therapy 
sessions will be listened to and viewed only in confidential settings by the project staff supervising the 
therapists and assisting with treatment development, and the therapists themselves. 
 
10 
RECRUITMENT STRATEGY 
Participants will be recruited from local physician offices, social media, advertisements, and local 
listservs. Potential participants will be asked to contact the study RC for more information. Potential 
participants will complete a screening questionnaire by phone with the RC, which will determine if they 
meet general study criteria. 
 
11 
CONSENT PROCESS 
Patients responding to advertisements for participation will be asked by the RC if they are interested in 
hearing about the research study. Verbal consent must be obtained prior to obtaining any information 
about the participant other than contact information. After receiving information by phone and 
completing a phone consent screener in order to determine initial eligibility, they will be provided with 
written descriptions of the investigation, and the study will be explained in person by the RC before 
consenting. Participants will be provided an opportunity to have questions addressed by the PIs. 
Finally, participants will be required to sign a consent form approved by the IRB at UNC to participate in 
the proposed study. As detailed above, informed consent will be obtained by the research coordinator 
and not by a person with perceived authority, such as a treating physician. 
 
12 
PLANS FOR PUBLICATION 
The primary outcome paper will include post-treatment, 3-month, and 6-month data on primary and 
secondary outcomes. Secondary papers will include coding of couple interactions and other secondary 
analysis results. 
 
13 
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16 
 
Table 1. 
Comparison of Intervention Arms 
 
 
 
 
Table 1: Comparison of Intervention Arms
 
Discipline 
UNITE 
(16 sessions) 
Individual CBT-E  
(16 sessions)
Medical  
 
Psychiatrist (1)
Psychiatrist (1)
Medical consults (as 
needed)
Medical consults (as 
needed)
Psycho-
therapy 
UNITE Couple Sessions 
(one 120-minute intro 
session, one 90-minute 
second session and 
fourteen 60 minute 
sessions) 
1050 minutes
Individual CBT-E  
(one 120-minute intro 
session, one 90-minute 
second session and 
fourteen 60 minute 
sessions) 
1050 minutes

17 
 
Table 2.  
UNITE Manual Components 
 
 
 
 
 
Table 2. UNITE Manual Components
Session
Topic
Early Treatment
1
Introduction to UNITE and Relationship Assessment
2
Understanding BED in a Couples Context: Symptoms and Course of Illness
3
BED Etiology, Treatment Goals, and Recovery
Mid-Treatment
4-14
Target 1: Communication around BED 

Emotional expressiveness communication skills
Target 2: Problem-solving/Behavioral Change Skills

Problem-solving communication skills 

Balanced eating

Mealtimes, food purchasing and preparation
Target 3: Partner-Assisted Emotion Regulation

BED triggers and recovery cues

Managing emotions effectively as a couple

Effective self-care (i.e., physical activity, sleeping, relaxation)
*Additional topics as needed:

Body image, weight stigma 

Weight and health concerns

Physical affection and sexuality

*Flex session (incorporated anytime in treatment)

*Flex session (incorporated anytime in treatment)
Late Treatment
15
Relapse Prevention 
16
Relapse Prevention and Termination 
* Topics selected according to patient/couple needs

18 
 
Table 3. 
Assessment Instruments and Schedule 
 
 
 
 
Table 3. Assessment Instruments and Schedule 
Assessment 
Screen 
Pre 
Mid 
Post 
3 mo 
6 mo 
Phone Screen 
1 
 
 
 
 
 
Background Info 
 
1,2 
 
 
 
 
Eating Disorder Pathology 
EDE-Q 
 
1 
1 
1 
1 
1 
BES 
 
1 
1 
1 
1 
1 
YBOCS-BE  
 
1 
1 
1 
 
1 
BE Frequency* 
 
1 
1 
1 
1 
1 
Height/Weight, Vitals 
 
1,2 
1,2 
1,2 
1,2 
1,2 
Mood/Psychological Functioning 
SCID 
 
1,2 
 
 
 
 
BDI-II 
 
1,2 
1,2 
1,2 
1,2 
1,2 
BAI  
 
1,2 
1,2 
1,2 
1,2 
1,2 
DERS  
 
1,2 
1,2 
1,2 
1,2 
1,2 
DERS-Partner  
 
1,2 
1,2 
1,2 
1,2 
1,2 
Relationship Adjustment and Communication 
DAS*  
 
1,2 
1,2 
1,2 
1,2 
1,2 
MSI-R 
 
 
 
 
 
 
CPQ-SF  
 
1,2 
1,2 
1,2 
1,2 
1,2 
BISF  
 
1,2 
1,2 
1,2 
1,2 
1,2 
EDQOL 
 
1 
1 
1 
1 
1 
CTSR  
 
1,2 
 
 
 
 
Videotaped 
Interactions 
 
1,2 
 
1,2 
1,2 
1,2 
CSQ 
 
 
 
1,2 
 
 
Therapist Feedback 
 
 
 
3 
 
 
1 = Patient, 2 = Partner, 3 = UNITE Therapist 
Pre = Pre-treatment, Mid = Mid-treatment, Post = Post-treatment, 3 mo = 
3-month follow-up 
*Binge eating and purging frequency, weekly