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Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms

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ClinicalTrials.gov Identifier: NCT03040076
Recruitment Status : Terminated (Data collection suggested that more work was needed to validate the theoretical connections between the constructs of interest, before doing a treatment trial.)
First Posted : February 2, 2017
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Florida State University

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.

Condition or disease Intervention/treatment Phase
Eating Disorder Symptom Emotional Maladjustment Negative Thoughts Behavioral: Cognitive Bias Treatment Behavioral: Relaxation Condition Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms: A Cognitive Bias Intervention
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : May 3, 2017

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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."

  4. 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).

  5. 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.

  6. 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).

  7. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040076


Locations
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United States, Florida
Eating Behaviors Research Clinic, Department of Psychology, Florida State University
Tallahassee, Florida, United States, 32308
Sponsors and Collaborators
Florida State University
Investigators
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Principal Investigator: Pamela K Keel, Ph.D. Department of Psychology, Florida State University

Publications:
Van Strien T, Frijters JE, Bergers G, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders 5(2): 295-315, 1986.
Spielberger CD, Reheiser EC. Assessment of emotions: Anxiety, anger, depression, and curiosity. Applied Psychology: Health and Well-Being 1(3): 271-302, 2009.
Hindash AHC, Amir N. Negative interpretation bias in individuals with depressive symptoms. Cognitive Therapy and Research 36(5): 502-511, 2012.
Kirschbaum, C. (2010). Trier social stress test. In I.P. Stolerman (Ed.), Encyclopedia of Psychopharmacology (pp. 1346-1346). Germany: Springer Berlin Heidelberg.
World Health Organization. (2000). Part I: The problem of overweight and obesity. In Obesity: Preventing and managing the global epidemic. Retrieved from http://libdoc.who.int/trs/WHO_TRS_894.pdf
First, M.B., Williams, J.B.W., Karg, R.S., & Spitzer, R.L (2015). Structured clinical interview for DSM-5 disorders. Arlington, VA: American Psychiatric Publishing.
Lovibond, S. H., & Lovibond, P. F. (1995). Manual for the Depression Anxiety Stress Scales (DASS). Sydney, Australia: Psychology Foundation of Australia.
Spielberger, C. D. (1999). State-Trait Anger Expression Inventory-2: Professional Manual. Lutz, FL: Psychological Assessment Resources.
Yiend J, Parnes C, Shepherd K, Roche MK, Cooper M. Negative self-beliefs in eating disorders a cognitive-bias-modification study. Clinical Psychological Science, 2(6): 756-766, 2014.
Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment 26(1): 41-54, 2004.

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Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT03040076     History of Changes
Other Study ID Numbers: 2016.19855
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders