Uniting Couples In the Treatment of Eating Disorders (UNITE): Pilot Study for a Couple-based Intervention for Binge-eating Disorder

University of North Carolina, Chapel Hill1 site in 1 country11 target enrollmentSeptember 2014

ConditionsBinge-eating Disorder Eating Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Binge-eating Disorder
Sponsor: University of North Carolina, Chapel Hill
Enrollment: 11
Locations: 1
Primary Endpoint: Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Detailed Description

Although current individual treatments exist for BED (e.g., cognitive-behavior therapy and interpersonal psychotherapy) about 20% of individuals who complete treatment and who are abstinent from binge eating post-treatment relapse within one year. In addition, dropout of BED treatment is high (approximately 10 - 33%), indicating that a significant number of individuals with BED fail to achieve relief from their symptoms. Couple-based interventions, which enlist the support of a partner into the treatment setting, are effective for treating anxiety and depression--frequently comorbid conditions with BED. Preliminary findings of couple-based treatment for anorexia nervosa suggests it assists in reducing drop out and improving outcome. Thus, the investigators developed a novel couple-based intervention for adult BED (UNITE-BED Edition) and plan to investigate it in an open treatment trial to examine it's feasibility, acceptability, and preliminary efficacy. Both patients and partners will be involved in all psychotherapy sessions of the treatment. Couples' progress will be followed for three months after completion of active treatment.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of North Carolina, Chapel Hill

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient

Time Frame: Post-treatment (on average 6 months after beginning treatment)

8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.

Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Partner

Time Frame: Post-treatment (on average 6 months after beginning treatment)

8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.

Secondary Outcomes

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))
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 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))
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Total 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) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP)(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II (BDI-II) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Partner(Baseline, Post-treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP) Total Score- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner(Baseline, 3-Month Follow-up)
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner(Baseline, Post-Treatment (on average 6 months after beginning treatment))
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner(Baseline, 3-Month Follow-up)