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Uniting Couples In the Treatment of Eating Disorders (UNITE)

NCT ID: NCT02419326

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Binge-eating Disorder Eating Disorder

Keywords

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couples relationships binge eating eating disorder couple therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Couples

The patient and their significant other receive psychotherapy treatment for the patient's BED.

Group Type EXPERIMENTAL

Psychotherapy treatment

Intervention Type BEHAVIORAL

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.

Interventions

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Psychotherapy treatment

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Participant with BED:

1. Subject currently meets criteria for BED or sub-threshold symptoms, according to the Diagnostic and Statistical Manual of Mental Disorders (5th Ed)
2. Concurrent outpatient therapy and medical monitoring
3. Health insurance coverage

Both members of the couple:

1. English speaking and able to read
2. Involved in a committed relationship for at least 6 months regardless of sexual orientation (couple is not required to live together)
3. Willing to participate in treatment

Exclusion Criteria

Participant with BED:

1\) Post-bariatric

Both members of the couple:

1. Alcohol or drug dependence in the last year
2. Current significant suicidal ideation
3. Severe depression that would seriously interfere with functional capacity
4. Developmental disability that would impair the ability to benefit from intervention
5. Any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year
6. Moderate to high levels of physical violence from either partner as reported on the Conflict Tactics Scale-2 at pre-treatment
7. Unwillingness to forgo non-protocol concurrent couples therapy
8. Previously participated in the preliminary couples treatment study UCAN: Uniting Couples (in the treatment of) Anorexia Nervosa (NCT01740752)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hilda & Preston Davis Foundation

OTHER

Sponsor Role collaborator

Global Foundation for Eating Disorders

UNKNOWN

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cristin D Runfola, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UNC Center of Excellence for Eating Disorders

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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14-1599

Identifier Type: -

Identifier Source: org_study_id