Uniting Couples In the Treatment of Eating Disorders (UNITE)

Binge-eating Disorder Clinical Trial

— UNITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419326
• Other study ID #: 14-1599
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: October 25, 2016
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge-eating Disorder
• Bulimia
• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UNC Center of Excellence for Eating Disorders	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Global Foundation for Eating Disorders, The Hilda & Preston Davis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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.	Post-treatment (on average 6 months after beginning treatment)	No
Secondary	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.	3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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	Baseline, 3-Month Follow-up	No
Secondary	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	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No
Secondary	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.	Baseline, Post-Treatment (on average 6 months after beginning treatment)	No
Secondary	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.	Baseline, 3-Month Follow-up	No