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Uniting Couples In the Treatment of Eating Disorders (UNITE) (UNITE)

Primary Purpose

Binge-eating Disorder, Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy treatment
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-eating Disorder focused on measuring couples, relationships, binge eating, eating disorder, couple therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UNC Center of Excellence for Eating Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Couples

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of patients with binge-eating remission (0 objective binge episodes over last 28 days) at post-treatment determined by Eating Disorder Examination (EDE)
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
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)
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective binge and subjective episodes and days over the 28 days prior to the assessment period.
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Change from Baseline to Post-Treatment in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
16-item self-report scale assessing the presence of specific binge-eating behaviors commonly observed in individuals with BED.
Change from Baseline to 3-Month Follow-up in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
16-item self-report scale assessing the presence of specific binge-eating behaviors commonly observed in individuals with BED.
Change from Baseline to Post-Treatment in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
Change from Baseline to 3-Month Follow-up in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Total Score- Patient
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about eating disorder symptoms and severity over the 28 days prior to the assessment period.
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Total Score- Patient
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about eating disorder symptoms and severity over the 28 days prior to the assessment period.
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
8-item self-report scale assessing beliefs about the controllability of obesity.
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
8-item self-report scale assessing beliefs about the controllability of obesity.
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Patient
20-item self-report scale assessing perceptions and attitudes about obese people.
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP)
20-item self-report scale assessing perceptions and attitudes about obese people.
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI) Total Score- Patient
21-item self-report scale assessing severity of current depressive symptoms.
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II (BDI-II) Total Score- Patient
21-item self-report scale assessing severity of current depressive symptoms.
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
21-item self-report scale assessing severity of current anxiety symptoms.
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
21-item self-report scale assessing severity of current anxiety symptoms.
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Patient
32-item self-report scale assessing the quality of the relationship perceived by participants
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Patient
32-item self-report scale assessing the quality of the relationship perceived by participants
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Partner
32-item self-report scale assessing the quality of the relationship perceived by participants
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Partner
32-item self-report scale assessing the quality of the relationship perceived by participants
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Change from Baseline to Post-Treatment in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
30-item self-report scale assessing accommodating and enabling behaviors of caregivers of people with eating disorders, including subscales for avoidance, modifying routines, reassurance seeking, meal rituals, control of family, and turning a blind eye. Measure edited to be specific to the significant other.
Change from Baseline to 3-Month Follow-up in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
30-item self-report scale assessing accommodating and enabling behaviors of caregivers of people with eating disorders, including subscales for avoidance, modifying routines, reassurance seeking, meal rituals, control of family, and turning a blind eye. Measure edited to be specific to the significant other.
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
8-item self-report scale assessing beliefs about the controllability of obesity.
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
8-item self-report scale assessing beliefs about the controllability of obesity.
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Partner
20-item self-report scale assessing perceptions and attitudes about obese people.
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP) Total Score- Partner
20-item self-report scale assessing perceptions and attitudes about obese people.
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
21-item self-report scale assessing severity of current depressive symptoms.
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
21-item self-report scale assessing severity of current depressive symptoms.
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
21-item self-report scale assessing severity of current anxiety symptoms.
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
21-item self-report scale assessing severity of current anxiety symptoms.
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.

Full Information

First Posted
March 31, 2015
Last Updated
October 25, 2016
Sponsor
University of North Carolina, Chapel Hill
Collaborators
The Hilda & Preston Davis Foundation, Global Foundation for Eating Disorders
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1. Study Identification

Unique Protocol Identification Number
NCT02419326
Brief Title
Uniting Couples In the Treatment of Eating Disorders (UNITE)
Acronym
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
The Hilda & Preston Davis Foundation, Global Foundation for Eating Disorders

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-eating Disorder, Eating Disorder
Keywords
couples, relationships, binge eating, eating disorder, couple therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Couples
Arm Type
Experimental
Arm Description
The patient and their significant other receive psychotherapy treatment for the patient's BED.
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient
Description
8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.
Time Frame
Post-treatment (on average 6 months after beginning treatment)
Title
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Partner
Description
8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.
Time Frame
Post-treatment (on average 6 months after beginning treatment)
Secondary Outcome Measure Information:
Title
Number of patients with binge-eating remission (0 objective binge episodes over last 28 days) at post-treatment determined by Eating Disorder Examination (EDE)
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Time Frame
Post-treatment (on average 6 months after beginning treatment)
Title
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)
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Time Frame
3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective binge and subjective episodes and days over the 28 days prior to the assessment period.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about the number of objective and subjective binge episodes and days over the 28 days prior to the assessment period.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
Description
16-item self-report scale assessing the presence of specific binge-eating behaviors commonly observed in individuals with BED.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
Description
16-item self-report scale assessing the presence of specific binge-eating behaviors commonly observed in individuals with BED.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Description
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Description
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Total Score- Patient
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about eating disorder symptoms and severity over the 28 days prior to the assessment period.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Total Score- Patient
Description
Clinical interview used to establish the diagnosis of BED and eating disorder severity. It inquires about eating disorder symptoms and severity over the 28 days prior to the assessment period.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
Description
8-item self-report scale assessing beliefs about the controllability of obesity.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
Description
8-item self-report scale assessing beliefs about the controllability of obesity.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Patient
Description
20-item self-report scale assessing perceptions and attitudes about obese people.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP)
Description
20-item self-report scale assessing perceptions and attitudes about obese people.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI) Total Score- Patient
Description
21-item self-report scale assessing severity of current depressive symptoms.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II (BDI-II) Total Score- Patient
Description
21-item self-report scale assessing severity of current depressive symptoms.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
Description
21-item self-report scale assessing severity of current anxiety symptoms.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
Description
21-item self-report scale assessing severity of current anxiety symptoms.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
Description
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
Description
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
Description
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
Description
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
Description
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
Description
12-item self-report scale assessing eight different items of functioning over the last month: physical functioning, energy/vitality, bodily pain, social functioning, role limitations due to emotional problems, mental health, and general health.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Patient
Description
32-item self-report scale assessing the quality of the relationship perceived by participants
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Patient
Description
32-item self-report scale assessing the quality of the relationship perceived by participants
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Partner
Description
32-item self-report scale assessing the quality of the relationship perceived by participants
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Partner
Description
32-item self-report scale assessing the quality of the relationship perceived by participants
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
Description
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
Description
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
Description
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
Description
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
Description
32-item self-report scale assessing communication between partners. The measure has two subscales: Problem Solving Communication (PSC) and Affective Communication (AFC). The 19 true-false items on the PSC reflect three domains: difficulty resolving minor differences, lack of problem solving skills, and inability to discuss sensitive issues. The 13 true-false items on the AFC reflect two dimensions: lack of support/affection and limited disclosure of feelings or lack of understanding.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
Description
30-item self-report scale assessing accommodating and enabling behaviors of caregivers of people with eating disorders, including subscales for avoidance, modifying routines, reassurance seeking, meal rituals, control of family, and turning a blind eye. Measure edited to be specific to the significant other.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
Description
30-item self-report scale assessing accommodating and enabling behaviors of caregivers of people with eating disorders, including subscales for avoidance, modifying routines, reassurance seeking, meal rituals, control of family, and turning a blind eye. Measure edited to be specific to the significant other.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
Description
8-item self-report scale assessing beliefs about the controllability of obesity.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
Description
8-item self-report scale assessing beliefs about the controllability of obesity.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Partner
Description
20-item self-report scale assessing perceptions and attitudes about obese people.
Time Frame
Baseline, Post-treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP) Total Score- Partner
Description
20-item self-report scale assessing perceptions and attitudes about obese people.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
Description
21-item self-report scale assessing severity of current depressive symptoms.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
Description
21-item self-report scale assessing severity of current depressive symptoms.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
Description
21-item self-report scale assessing severity of current anxiety symptoms.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
Description
21-item self-report scale assessing severity of current anxiety symptoms.
Time Frame
Baseline, 3-Month Follow-up
Title
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
Description
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Time Frame
Baseline, Post-Treatment (on average 6 months after beginning treatment)
Title
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
Description
36-item self-report scale assessing four key areas in emotion regulation: 1) awareness and understanding, 2) acceptance of emotions, 3) ability to control impulsive behaviors when having negative emotions, and 4) ability to use emotion regulation strategies.
Time Frame
Baseline, 3-Month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 1) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristin D Runfola, Ph.D.
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Center of Excellence for Eating Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Uniting Couples In the Treatment of Eating Disorders (UNITE)

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