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N/A N=44 Randomized Single-blind Treatment

Uniting Couples in the Treatment of Binge-Eating Disorder

Binge-Eating Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03784820 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence — 2; 1; 5; 4 Participants — p=0.36

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
UNITE (Behavioral); CBT-E (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence		 2; 1; 5; 4; 5; 5 0.36
SECONDARY
Mean Binge-eating Frequency in Modified Intent-to-Treat Patients		 12.45; 14.50; 6.70; 3.88; 1.00; 1.50 0.52
SECONDARY
Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients		 2.97; 3.53; 1.89; 2.81; 1.77; 1.82 0.86
SECONDARY
Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients		 25.40; 28.83; 15.17; 17.76; 9.56; 11.30 0.33
SECONDARY
Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients		 17.91; 17.10; 14.11; 13.13; 6.32; 7.38 0.62
SECONDARY
Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners		 18.82; 19.50; 10.90; 14.88; 7.14; 12.00 0.10
SECONDARY
Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners		 8.18; 13.40; 8.00; 12.25; 9.43; 5.71 0.91
SECONDARY
Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners		 85.73; 97.60; 77.60; 90.13; 79.00; 73.71 0.85
SECONDARY
Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners		 15.36; 16.60; 13.89; 19.38; 15.86; 16.71 0.91
SECONDARY
Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners		 112.27; 109.60; 115.44; 112.00; 117.29; 119.29 0.90
SECONDARY
Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners		 15.91; 16.30; 17.33; 16.13; 16.71; 17.00 0.84
SECONDARY
Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners		 18.55; 20.70; 16.33; 18.38; 18.57; 15.29 0.50
SECONDARY
Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients		 1.22; 1.38; 0.86; 1.10; 0.86; 0.73 0.70
SECONDARY
Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners		 5.64; 7.20; 6.22; 8.25; 6.14; 6.14 0.89
SECONDARY
Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners		 4.09; 4.30; 3.67; 5.13; 3.57; 2.57 0.41
SECONDARY
Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners		 28.71; 29.24; 30.38 0.79

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03784820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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