Clinical trial NCT03040076: Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms
Official title: Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms: A Cognitive Bias Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eating Disorder Symptom
Emotional Maladjustment
Negative Thoughts
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Emotional Overeating Questionnaire Scores
timeFrame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
measure: Change in Positive and Negative Affect Schedule Scores
timeFrame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
measure: Change in Word Sentence Association Paradigm Scores
timeFrame: Assessed at baseline (time zero), mid-treatment (8 days after baseline), and post-treatment (2 weeks after baseline).
Secondary outcomes:
measure: Body Mass Index
timeFrame: Assessed at baseline (time zero).
measure: Eating Pathology Symptoms Inventory
timeFrame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
measure: Depression and Anxiety Stress Scale
timeFrame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
measure: State-Trait Anger Expression Inventory, Second Edition
timeFrame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
measure: Difficulties in Emotion Regulation Scale
timeFrame: Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).
measure: Visual Analogue Scale Ratings
timeFrame: Assessed at post-treatment (2 weeks after baseline).
measure: Frozen Yogurt Consumption
timeFrame: Assessed at post-treatment (2 weeks after baseline).
Other outcomes:
measure: Psychological History
timeFrame: Assessed at baseline (time zero).
Locations:
city: Tallahassee
country: United States
facility: Eating Behaviors Research Clinic, Department of Psychology, Florida State University
state: Florida
Study officials:
affiliation: Department of Psychology, Florida State University
name: Pamela K Keel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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