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
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorder Symptom Emotional Maladjustment Negative Thoughts||Behavioral: Cognitive Bias Treatment Behavioral: Relaxation Condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Cognitive Bias Treatment
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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."
- 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).
- 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.
- 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).
- 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.
- 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.
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
|United States, Florida|
|Eating Behaviors Research Clinic, Department of Psychology, Florida State University|
|Tallahassee, Florida, United States, 32308|
|Principal Investigator:||Pamela K Keel, Ph.D.||Department of Psychology, Florida State University|