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

October 25, 2016 updated by: University of North Carolina, Chapel Hill

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Center of Excellence for Eating Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Couples
The patient and their significant other receive psychotherapy treatment for the patient's BED.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Post-treatment (on average 6 months after beginning 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.
Post-treatment (on average 6 months after beginning treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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
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
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)
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)
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
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
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)
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)
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
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
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)
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)
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
16-item self-report scale assessing the presence of specific binge-eating behaviors commonly observed in individuals with BED.
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)
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)
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
Clinical interview used to assess obsessiveness of binge-eating thoughts and compulsiveness of binge-eating behaviors.
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)
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)
Change from Baseline to 3-Month Follow-up in the Eating Disorder Examination (EDE) Total Score- Patient
Time Frame: Baseline, 3-Month Follow-up
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
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)
8-item self-report scale assessing beliefs about the controllability of obesity.
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
8-item self-report scale assessing beliefs about the controllability of obesity.
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)
20-item self-report scale assessing perceptions and attitudes about obese people.
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
20-item self-report scale assessing perceptions and attitudes about obese people.
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)
21-item self-report scale assessing severity of current depressive symptoms.
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
21-item self-report scale assessing severity of current depressive symptoms.
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)
21-item self-report scale assessing severity of current anxiety symptoms.
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
21-item self-report scale assessing severity of current anxiety symptoms.
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)
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)
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
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
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)
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)
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
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
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)
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)
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
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
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)
32-item self-report scale assessing the quality of the relationship perceived by participants
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
32-item self-report scale assessing the quality of the relationship perceived by participants
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)
32-item self-report scale assessing the quality of the relationship perceived by participants
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
32-item self-report scale assessing the quality of the relationship perceived by participants
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)
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)
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
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
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)
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)
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
11-item self-report scale assessing how couple communicates about eating and binge eating disorder.
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)
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)
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
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
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)
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)
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
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
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)
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)
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
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
Change from Baseline to Post-Treatment in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
Time Frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
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)
Change from Baseline to 3-Month Follow-up in the Marital Satisfaction Inventory-Revised (MSI-R) Affective Communication (AFC)- Partner
Time Frame: Baseline, 3-Month Follow-up
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
Change from Baseline to Post-Treatment in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
Time Frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
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)
Change from Baseline to 3-Month Follow-up in the Accommodation and Enabling Scale for Eating Disorders (AESED)- Partner
Time Frame: Baseline, 3-Month Follow-up
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
Change from Baseline to Post-Treatment in the Beliefs about Obese People Scale (BAOP) Total Score- Partner
Time Frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
8-item self-report scale assessing beliefs about the controllability of obesity.
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
Time Frame: Baseline, 3-Month Follow-up
8-item self-report scale assessing beliefs about the controllability of obesity.
Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Attitudes Towards Obese People (ATOP) Total Score- Partner
Time Frame: Baseline, Post-treatment (on average 6 months after beginning treatment)
20-item self-report scale assessing perceptions and attitudes about obese people.
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
Time Frame: Baseline, 3-Month Follow-up
20-item self-report scale assessing perceptions and attitudes about obese people.
Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Beck Depression Inventory-II Scale (BDI-II) Total Score- Partner
Time Frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
21-item self-report scale assessing severity of current depressive symptoms.
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
Time Frame: Baseline, 3-Month Follow-up
21-item self-report scale assessing severity of current depressive symptoms.
Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Beck Anxiety Inventory Scale (BAI) Total Score- Partner
Time Frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
21-item self-report scale assessing severity of current anxiety symptoms.
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
Time Frame: Baseline, 3-Month Follow-up
21-item self-report scale assessing severity of current anxiety symptoms.
Baseline, 3-Month Follow-up
Change from Baseline to Post-Treatment in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
Time Frame: Baseline, Post-Treatment (on average 6 months after beginning treatment)
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)
Change from Baseline to 3-Month Follow-up in the Difficulties in Emotion Regulation Scale (DERS) Total Score- Partner
Time Frame: Baseline, 3-Month Follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hilda & Preston Davis Foundation
Global Foundation for Eating Disorders

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cristin D Runfola, Ph.D., University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-1599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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