Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms

June 21, 2018 updated by: Florida State University

Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms: A Cognitive Bias Intervention

The purpose of this study to test a computerized treatment designed to help people with high levels of emotional eating, which is when people eat to cope with negative emotions and/or stressful situations. The investigators are interested in comparing two different ways of coping with negative emotions, relaxation training or training in how to think differently about such situations. Additionally, the researchers' study seeks to understand more about the psychological factors that may contribute to someone having difficulty with emotional eating.

Study Overview

Status

Status

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

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

Emotional eating, or eating as a mechanism for coping with negative affect, is present across a spectrum of eating disorders and is associated with poor health outcomes, namely obesity. Research suggests that individuals with emotional eating experience urges to eat in response to multiple negative emotions, including anxiety, depression, and anger. While emotional eating is related to binge eating, it can be examined in a more dimensional fashion because it is not associated with a specific size criterion or a requirement of loss of control over eating. As such, emotional eating is a useful analog through which to understand mechanisms of binge eating and test the preliminary efficacy of treatment interventions. Interventions that target mechanisms of regulating negative affect may reduce both negative affect and emotional eating, increasing their transdiagnostic value. Research suggests that a large gap exists between the prevalence of psychopathology and access to psychological treatment, and this gap extends to individuals with eating disorders. A potential solution to these challenges is the use of computerized methodologies that may be easier to disseminate, allow for a gradient of treatment intensity, and do not rely upon training treatment providers. Computer-administered CBM interventions address the need for more easily disseminated treatments. CBM interventions are based in research suggesting that negative interpretation biases cause negative emotionality and subsequent symptom expression. Negative interpretation biases are the tendency to draw threatening conclusions about ambiguous information. Thus, CBM paradigms train people to make neutral or positive attributions about situations they would typically view through the lens of their negative biases. CBM interventions have been tested across a range of psychopathology, including anxiety disorders, depression, and anger, and using a variety of different bias modification techniques. Two recent CBM studies have been tested within the field of eating disorders. Although results were promising, both studies were marked by methodological limitations and neither addressed emotional eating specifically. The purpose of the present study is to test a CBM intervention designed to help individuals with elevated emotional eating improve their ability to regulate negative affect. In doing so, the investigators will determine if modifying the interpretation of ambiguous situations that would typically result in negative affect can reduce negative affect in individuals with high emotional eating. The researchers will in turn determine if those individuals have decreased food consumption under conditions that would otherwise elicit negative emotions. This project extends initial research on CBMs in eating disorders, as well as research suggesting that basic emotion regulation training can decrease emotional eating.

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.
28

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
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Eating Behaviors Research Clinic, Department of Psychology, Florida State University

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 to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female between the ages of 18 and 45 years of age
  • An emotional eating score more than one SD above the mean (>2.9) on the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating scale (van Strien, Frijters, Bergers, & Defares, 1986).
  • Regular computer and internet access
  • Rate liking of vanilla frozen yogurt as a 6 or higher on a 10 point scale.

Exclusion Criteria:

  • Body mass index (BMI; kg/m2) less than 18.5 (World Health Organization, 2000), given known cognitive impairments that can result from being underweight (Fowler et al., 2006).
  • Current psychotic, manic, or substance use disorders, as these may interfere with their ability to cognitively engage in the intervention.
  • Food allergies that would prevent consumption of vanilla frozen yogurt.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

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: Cognitive Bias Treatment
Intervention condition
Behavioral: Cognitive Bias Treatment
Two computerized tasks will be administered during four intervention sessions. During the first task, the Word Sentence Association Paradigm, participants see a threat or benign word and then an ambiguous sentence. Participants press one if they believe the word and sentence are related and two if they believe the word and sentence are not related. Participants are given feedback that they responded correctly if they state that a benign word is related to the sentence or they state that a threat word is not related to the sentence. The second task is the Ambiguous Scenarios Task. In each trial, an ambiguous scenario, ending in a benign word, appears on the screen. After the scenario is presented, participants respond to a comprehension question and are given feedback on their performance.
ACTIVE_COMPARATOR: Relaxation Condition
Active control condition
Behavioral: Relaxation Condition
Participants assigned to the active control group will complete four sessions of progressive muscle relaxation training. Two alternating relaxation scripts will be used. The scripts will be presented as Youtube videos with a blank black screen and will instruct participants to keep their eyes closed for the duration of the training. Participants will access the videos through Qualtrics to ensure that data can be gathered about their compliance. The relaxation scripts used in the present study will be modified versions of those currently being tested by other researchers utilizing cognitive bias modification paradigms. The relaxation training sessions will be matched to the length of the treatment condition and therefore will last approximately 30 minutes.

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
Change in Emotional Overeating Questionnaire Scores
Time Frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Emotional eating will be measured using the 6-item Emotional Overeating Questionnaire (EOQ; Masheb & Grilo, 2006), in which participants report on the frequency of eating in response to five negative emotions and one positive emotion. The instructions and item scaling will be modified to decrease the timeframe assessed from 28 days to 5 days, in order to be sensitive to changes during the present intervention. Each item will be assessed on a 5-point scale (0= no days to 5 = every day). Further, the instructions will be modified to not specifically reference eating an objectively large amount of food. This change is made in order to ensure consistency with how emotional eating is conceptualized in the literature (i.e., no specific size criterion). Change in scores at each of the time points will be used to determine symptom improvement.
Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Change in Positive and Negative Affect Schedule Scores
Time Frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Negative affect will be assessed using the negative affect scale of the Positive and Negative Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988), which is a 10-item measure of negative emotions on a scale of 1 ("very slightly or not at all) to 5 ("extremely"). The instructions can be modified as needed to reflect the desired timeframe of assessment (Watson et al., 1988) and therefore, we will instruct participants to consider the past five days.Change in scores at each of the time points will be used to determine symptom improvement.
Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Change in Word Sentence Association Paradigm Scores
Time Frame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
A modified version of the treatment condition Word Sentence Association Paradigm (WSAP; Amir & Taylor, 2012b; Beard & Amir, 2008; Hindash & Amir, 2012) will be used to assess interpretation bias. The ambiguous sentences will be distinct from those used in the bias modification program in order to allow for a more generalized assessment of change in biases. However, to permit an accurate assessment of changes in bias, the WSAP task will be the same at pre-, mid and post treatment. Scores on the WSAP task are calculated as the ratio of percent threatening to percent benign interpretations across the trials. Change in scores at each of the time points will be used to determine symptom improvement.
Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).

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
Body Mass Index
Time Frame: Assessed at baseline (time zero).
Body mass index (BMI) will be computed using participants' height, measured with a wall-mounted ruler, and weight, measured with an electronic scale.
Assessed at baseline (time zero).
Eating Pathology Symptoms Inventory
Time Frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Eating disorder symptoms will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from "never" to "very often." The EPSI scale is designed to assess behavior over the past 28 days (Forbush et al., 2013); however, to be sensitive to the timeframe of the present study, the instructions will be modified to ask participants to consider the past week.
Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Depression and Anxiety Stress Scale
Time Frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Depression, anxiety, and stress symptoms will be measured using the Depression and Anxiety Stress Scale (DASS; Lovibond & Lovibond, 1995a). The DASS is a 42-item measure that assesses such symptoms over the preceding week on a 0 to 3 scale from "did not apply to me at all" to "applied to me very much, or most of the time."
Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
State-Trait Anger Expression Inventory, Second Edition
Time Frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Anger symptoms will be measured using the trait anger scale of the State-Trait Anger Expression Inventory, Second Edition (STAXI-2; Spielberger, 1999). Only the trait scale will be used in the present study given our interest in assessing overall anger symptoms, not momentary anger levels, as a moderating variable. The trait scale consists of 10 items that assess frequency of anger a 4-point scale from "almost never" to "almost always," but is not measured across a specific timeframe (Spielberger & Reheiser, 2009).
Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Difficulties in Emotion Regulation Scale
Time Frame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Emotion dysregulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). The DERS is a 36-item measure of six aspects of emotion dysregulation; all items are measured on a 1 ("almost never") to 5 ("almost always") scale and are not anchored to a specific timeframe.
Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
Visual Analogue Scale Ratings
Time Frame: Assessed at post-treatment (2 weeks after baseline).
Before, during, and after a behavioral task designed to measure food consumption following stress, participants will complete Visual Analogue Scale (VAS; Rolls et al., 1992) ratings of hunger and fullness, as well as state affect (e.g., sad, anxious, frustrated, angry) by marking a 100-mm line (ends labeled from not at all to extremely).
Assessed at post-treatment (2 weeks after baseline).
Frozen Yogurt Consumption
Time Frame: Assessed at post-treatment (2 weeks after baseline).
Food intake will be measured as the difference in weight of the frozen yogurt before and after the test meal (Geliebter et al., 2012) that is part of the behavioral stress task. The investigators will also record the time taken (out of fifteen minutes) participants used to consume the food.
Assessed at post-treatment (2 weeks after baseline).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological History
Time Frame: Assessed at baseline (time zero).
Trained graduate students will administer modules of the Structured Clinical Interview for DSM 5 (SCID-5; First, Williams, Karg, & Spitzer, 2015), which will allow for an assessment of psychological treatment history and past/present eating disorder diagnoses.
Assessed at baseline (time zero).

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.
Florida State University

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: Pamela K Keel, Ph.D., Department of Psychology, Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

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.
March 28, 2017

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.
May 3, 2017

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.
May 3, 2017

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).
January 4, 2017

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.
January 30, 2017

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.
February 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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.
June 26, 2018

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.
June 21, 2018

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.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 2016.19855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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