Clinical trial NCT03784820: Uniting Couples in the Treatment of Binge-Eating Disorder
Official title: Targeting Relationship Domains in Community-Based Treatment of Binge-Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Keywords: Binge-Eating Disorder
Eating disorders
Couple therapy
CBT
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Utah
First posted: 2018-12-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence
timeFrame: Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)
Secondary outcomes:
measure: Mean Binge-eating Frequency in Modified Intent-to-Treat Patients
timeFrame: 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)
measure: Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients
timeFrame: 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)
measure: Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients
timeFrame: 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)
measure: Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients
timeFrame: Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)
measure: Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients
timeFrame: 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)
measure: Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners
timeFrame: 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)
measure: Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners
timeFrame: Post (after 16 weekly treatment sessions) (T2)
Other outcomes:
measure: Couple Communication Measured by Observational Coding of Recorded Couple Conversations
timeFrame: From Pre-treatment through Follow-up
measure: Couple Interpersonal Problem-solving/Behavior Change Skills Measured by Observational Coding of a Recorded Couple Conversation
timeFrame: From Pre-treatment through Follow-up
measure: Partner-assisted Emotion Regulation Assessed With Vocally Encoded Emotional Arousal
timeFrame: From Pre-treatment through Follow-up
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Cynthia Bulik, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Donald Baucom, PhD
role: PRINCIPAL_INVESTIGATOR
References: