Clinical trial NCT02419326: Uniting Couples In the Treatment of Eating Disorders (UNITE)
Official title: Uniting Couples In the Treatment of Eating Disorders (UNITE): Pilot Study for a Couple-based Intervention for Binge-eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-eating Disorder
Eating Disorder
Keywords: couples
relationships
binge eating
eating disorder
couple therapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: The Hilda & Preston Davis Foundation
name: Global Foundation for Eating Disorders
First posted: 2015-04-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient
timeFrame: Post-treatment (on average 6 months after beginning treatment)
measure: Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Partner
timeFrame: Post-treatment (on average 6 months after beginning treatment)
Secondary outcomes:
measure: Number of patients with binge-eating remission (0 objective binge episodes over last 28 days) at post-treatment determined by Eating Disorder Examination (EDE)
timeFrame: Post-treatment (on average 6 months after beginning treatment)
measure: 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)
timeFrame: 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP)
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II (BDI-II) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Partner
timeFrame: Baseline, Post-treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
measure: Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
timeFrame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
measure: Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
timeFrame: Baseline, 3-Month Follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center of Excellence for Eating Disorders
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Cristin D Runfola, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: