Testing if Reductions in Negative Affect Yield Decreased Emotional Eating Symptoms

NCT03040076 | Terminated

• 1 other identifier: 2016.19855
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder Symptom; Emotional Maladjustment; Negative Thoughts

Outcome Measures

Primary Outcomes (3)

• Change in Emotional Overeating Questionnaire Scores

  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

  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

  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 Outcomes (7)

• Body Mass Index

  Assessed at baseline (time zero).

• Eating Pathology Symptoms Inventory

  Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).

• Depression and Anxiety Stress Scale

  Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).

• State-Trait Anger Expression Inventory, Second Edition

  Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).

• Difficulties in Emotion Regulation Scale

  Assessed at baseline (time zero) and post-treatment (2 weeks after baseline).

Other Outcomes (1)

• Psychological History

  Assessed at baseline (time zero).

Study Arms (2)

Cognitive Bias Treatment

EXPERIMENTAL

Intervention condition

Behavioral: Cognitive Bias Treatment

Relaxation Condition

ACTIVE COMPARATOR

Active control condition

Behavioral: Relaxation Condition

Interventions

Cognitive Bias Treatment BEHAVIORAL

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.

Cognitive Bias Treatment

Relaxation Condition BEHAVIORAL

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.

Relaxation Condition

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Eating Behaviors Research Clinic, Department of Psychology, Florida State University

Tallahassee, Florida, 32308, United States

Location

Related Publications (35)

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Study Officials

• Pamela K Keel, Ph.D.

  Department of Psychology, Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: February 2, 2017
• Study Start: March 28, 2017
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: June 26, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)