Uniting Couples In the Treatment of Eating Disorders (UNITE)
UNITE
1 other identifier
interventional
11
1 country
1
Brief Summary
The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a novel couple-based intervention for binge-eating disorder (BED).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 27, 2016
October 1, 2016
2.1 years
March 31, 2015
October 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient
8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.
Post-treatment (on average 6 months after beginning treatment)
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Partner
8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.
Post-treatment (on average 6 months after beginning treatment)
Secondary Outcomes (54)
Number of patients with binge-eating remission (0 objective binge episodes over last 28 days) at post-treatment determined by Eating Disorder Examination (EDE)
Post-treatment (on average 6 months after beginning treatment)
Number of patients with binge eating remission (0 objective binge-eating episodes in last 28 days) at 3-month follow-up determined by the Eating Disorder Examination (EDE)
3-Month Follow-up
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Baseline, Post-Treatment (on average 6 months after beginning treatment)
- +49 more secondary outcomes
Study Arms (1)
Couples
EXPERIMENTALThe patient and their significant other receive psychotherapy treatment for the patient's BED.
Interventions
UNITE is a manualized, 22-session CBCT (cognitive behavioral couples therapy) intervention that engages the couple to target the core psychopathology of BED and address the uniquely challenging stress that BED places on intimate relationships.
Eligibility Criteria
You may qualify if:
- Participant with BED:
- Subject currently meets criteria for BED or sub-threshold symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Ed)
- Concurrent outpatient therapy and medical monitoring
- Health insurance coverage
- Both members of the couple:
- English speaking and able to read
- Involved in a committed relationship for at least 6 months regardless of sexual orientation (couple is not required to live together)
- Willing to participate in treatment
You may not qualify if:
- Participant with BED:
- \) Post-bariatric
- Both members of the couple:
- Alcohol or drug dependence in the last year
- Current significant suicidal ideation
- Severe depression that would seriously interfere with functional capacity
- Developmental disability that would impair the ability to benefit from intervention
- Any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year
- Moderate to high levels of physical violence from either partner as reported on the Conflict Tactics Scale-2 at pre-treatment
- Unwillingness to forgo non-protocol concurrent couples therapy
- Previously participated in the preliminary couples treatment study UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa (NCT01740752)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristin D Runfola, Ph.D.
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2015
First Posted
April 17, 2015
Study Start
September 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
October 27, 2016
Record last verified: 2016-10