Binge-eating DisorderUNITENCT02419326
Uniting Couples In the Treatment of Eating Disorders (UNITE)
A study testing Psychotherapy treatment in people with Binge-eating Disorder and Eating Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-eating Disorder, Eating Disorder
- What is being tested?
- Psychotherapy treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, 27599
About this study
Official title: Uniting Couples In the Treatment of Eating Disorders (UNITE): Pilot Study for a Couple-based Intervention for Binge-eating Disorder
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).
Read the 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.
- Conditions
- Binge-eating Disorder, Eating Disorder
- Being tested
- Psychotherapy treatment
- Keywords
- couples, relationships, binge eating, eating disorder, couple therapy
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Couples | Experimental | The patient and their significant other receive psychotherapy treatment for the patient's BED. Receives: Behavioral: Psychotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (on average 6 months after beginning 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.
Measured: Post-treatment (on average 6 months after beginning treatment)
Secondary outcomes (54)
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.
Measured: Post-treatment (on average 6 months after beginning treatment)
Number of patients with binge eating remission (0 objective binge-eating episodes in last 28 days) at 3-month follow-up determined by the Eating Disorder Examination (EDE)
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.
Measured: 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
16-item self-report scale assessing the presence of specific binge-eating behaviors commonly observed in individuals with BED.
Measured: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Total Score- Patient
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
8-item self-report scale assessing beliefs about the controllability of obesity.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP)
20-item self-report scale assessing perceptions and attitudes about obese people.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II (BDI-II) Total Score- Patient
21-item self-report scale assessing severity of current depressive symptoms.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
21-item self-report scale assessing severity of current anxiety symptoms.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
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.
Measured: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
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.
Measured: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
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.
Measured: Baseline, 3-Month Follow-up
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
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Patient
32-item self-report scale assessing the quality of the relationship perceived by participants
Measured: Baseline, 3-Month Follow-up
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
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Partner
32-item self-report scale assessing the quality of the relationship perceived by participants
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
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.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
8-item self-report scale assessing beliefs about the controllability of obesity.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP) Total Score- Partner
20-item self-report scale assessing perceptions and attitudes about obese people.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
21-item self-report scale assessing severity of current depressive symptoms.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
21-item self-report scale assessing severity of current anxiety symptoms.
Measured: Baseline, 3-Month Follow-up
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.
Measured: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
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.
Measured: Baseline, 3-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-eating DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- The Hilda & Preston Davis Foundation, Global Foundation for Eating Disorders
- Responsible party
- Sponsor
- Investigators
- Cristin D Runfola, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419326
- Sponsor's protocol ID
- 14-1599
- Acronym
- UNITE
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uniting Couples In the Treatment of Eating Disorders (UNITE): Pilot Study for a Couple-based Intervention for Binge-eating Disorder
- ClinicalTrials.gov ID
- NCT02419326
- Acronym / sponsor ID
- UNITE / 14-1599
- Conditions
- Binge-eating Disorder, Eating Disorder
- Keywords
- couples, relationships, binge eating, eating disorder, couple therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- The Hilda & Preston Davis Foundation, Global Foundation for Eating Disorders
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples | Experimental | Behavioral: Psychotherapy treatmentThe patient and their significant other receive psychotherapy treatment for the patient's BED. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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)
Key exclusion criteria (11 listed)
- 1) Post-bariatric
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy treatmentUNITE 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. | Behavioural | Couples |
Primary outcome
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient
Time frame: Post-treatment (on average 6 months after beginning treatment)
8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Partner
Time frame: Post-treatment (on average 6 months after beginning treatment)
8-item self-report scale assessing the effectiveness of, and satisfaction with, content and format of treatment.
54 secondary outcomes
Number of patients with binge-eating remission (0 objective binge episodes over last 28 days) at post-treatment determined by Eating Disorder Examination (EDE)
Time frame: Post-treatment (on average 6 months after beginning treatment)
Number of patients with binge eating remission (0 objective binge-eating episodes in last 28 days) at 3-month follow-up determined by the Eating Disorder Examination (EDE)
Time frame: 3-Month Follow-up
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Binge Eating Episode Frequency Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Number of Days Binge Eating Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Binge Eating Scale (BES) Binge Eating Symptom Severity- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Eating Disorder Examination (EDE) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beliefs about Obese People Scale (BAOP) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Attitudes Towards Obese People (ATOP)
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beck Depression Inventory-II (BDI-II) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Beck Anxiety Inventory Scale (BAI) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS)- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the 12-Item Short Form Health Survey (SF-12) Mental Component Summary (MCS)- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Dyadic Adjustment Scale (DAS) Total Score- Partner
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Dyadic Adjustment Scale (DAS) Total Score- Partner
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Communication Patterns Questionnaire Short Form (CPQ-SF) Total Score- Partner
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Patient
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Problem Solving Communication (PSC)- Partner
Time frame: Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
Time frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Patient
Time frame: Baseline, 3-Month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristin D Runfola, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy treatment in people with Binge-eating Disorder and Eating Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score at Post-treatment of the Client Satisfaction Questionnaire-8 (CSQ-8)- Patient (time frame: Post-treatment (on average 6 months after beginning treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.