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Trial record 92 of 592 for:    binge eating disorder

A Pilot Test of Mood and Circadian Rhythm Mechanisms Driving Binge Eating

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ClinicalTrials.gov Identifier: NCT03680989
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle Patrick De Young, University of Wyoming

Brief Summary:
Mood and circadian rhythm disruptions are associated with binge eating (BE). BE is a discrete, episodic behavior characterized by 1) eating an objectively large amount of food and 2) experiencing a subjective sense of loss of control. BE episodes are often preceded by negative mood states, and a subtype of individuals with BE has high levels of negative moods. This group has more comorbid psychopathology and a poorer response to treatment. Thus, understanding the role of negative mood is a critical area for research on BE. Individuals with BE demonstrate disruptions in several circadian rhythms, including diurnal meal timing, hormone patterns (e.g., daily cortisol rhythms), and mood variations. The most potent synchronizer of circadian rhythms is light. Thus, exposure to light may explain other phenomena that fluctuate similarly, such as mood and the occurrence of BE. Mood is subject to the influence of light, and BE is also influenced by exposure to bright light. It is unknown whether regulating circadian rhythms via regular exposure to light improves BE through its effects on mood or via changes in other biological or behavioral rhythms. This knowledge can inform the development of treatments targeting biobehavioral mechanisms that maintain BE and indicate for whom this may be most effective. This project aims to test the roles of negative mood and circadian rhythms in the relationship between light exposure and BE and identify subtypes of individuals in whom this effect is strong. The investigators hypothesize that individuals exposed to less natural bright light will experience more frequent BE, more negative mood, and a blunted morning cortisol response. The investigators further hypothesize that manipulating exposure to artificial bright light will reduce the frequency of BE and negative mood and increase the morning cortisol response. Finally, the investigators hypothesize that the effects of this artificial bright light exposure on BE frequency will be mediated by changes in negative mood, which itself will be accounted for by changes in circadian rhythms as indicated by the morning cortisol response. Additionally, the investigators have two moderation hypotheses: that the effects of artificial bright light exposure on BE will be greater for those who fit the high negative mood type than those who do not and that the effects will be greater for individuals with a blunted morning cortisol response at baseline than for those without.

Condition or disease Intervention/treatment Phase
Eating Disorder Binge Eating Circadian Dysregulation Device: Bright Light Exposure Device: Natural Light Exposure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Test of Mood and Circadian Rhythm Mechanisms Driving Binge Eating
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Arm Intervention/treatment
Placebo Comparator: Natural Light
Participants will use a therapy light that provides ~500 lux at 22" for 30 minutes each morning beginning 30 minutes after waking.
Device: Natural Light Exposure
For 10 consecutive days, participants will use an Ultralux(R) V HD-LED light therapy light for 30 minutes beginning 30 minutes after waking. The light will be preset to deliver ~500 lux at 22".

Active Comparator: Bright Light
Participants will receive Bright Light Exposure using a therapy light that provides ~10,000 lux at 22" for 30 minutes each morning beginning 30 minutes after waking.
Device: Bright Light Exposure
For 10 consecutive days, participants will use an Ultralux(R) V HD-LED light therapy light for 30 minutes beginning 30 minutes after waking. The light will be preset to deliver ~10,000 lux at 22".




Primary Outcome Measures :
  1. Change in the Cortisol Awakening Response [ Time Frame: Assessed at baseline (days 1 and 2) and after each intervention (days 10 and 11 and days 21 and 22) ]
    The cortisol awakening response will estimated from saliva samples collected at home via passive drool (0.5 ml) at three times: immediately upon waking, 15 minutes after waking, and 30 minutes after waking. The curve of this response can be estimated from these three measurements. The response will be averaged over two consecutive days of collection and then compared between the two intervention phases to quantify the change in the awakening response accounted for by the interventions while controlling for the response at baseline before any interventions have been employed.

  2. Change in Binge Eating (i.e., degree of loss of control over eating) [ Time Frame: Multiple ratings per day for 22 days ]
    Participants will report using ecological momentary assessment (EMA) when they eat the degree to which they experienced their eating as out of control. These reports are provided after each eating episode that occurs during the study period (i.e., days 1 -22 of the protocol). The ratings will be averaged within protocol phases (i.e., average loss of control for eating episodes occurring during first intervention phase and the average during the second intervention phase) and compared to quantify the change in binge eating accounted for by the difference between the two interventions.

  3. Change in Momentary Negative Mood [ Time Frame: Multiple ratings per day for 22 days ]
    Participants will be signaled using ecological momentary assessment (EMA) at six times per day distributed across their waking hours and will be asked to provide momentary negative mood ratings. Participants will also be asked to initiate reports after they have eaten, and they will provide ratings for mood then as well. These ratings will be made on a scale ranging from 1 to 9 using a wrist-worn electronic device. The ratings will be averaged within protocol phases (i.e., average negative mood occurring during first intervention phase and the average during the second intervention phase) and compared to quantify the change in negative mood accounted for by the difference between the two interventions.


Secondary Outcome Measures :
  1. Change in severity of global eating disorder symptoms due to intervention phases [ Time Frame: Protocol day 0, 12, and 22 ]
    Participants will complete a self-report measure of recent change in eating disorder symptoms (the Change in Eating Disorder Symptoms Scale; Spangler, 2010) at laboratory visits as secondary, aggregate measures of clinical change. This measure contains seven subscales (body preoccupation, body dissatisfaction, body checking, binge eating, restrictive eating, food preoccupation, and vomiting) in addition to the total score. Thirty-five items are rated on a 0 to 4 scale, with higher scores indicating more severe eating disorder symptoms. The change in these symptom scores between baseline (protocol day 0) and each light phase (protocol days 12 and 22, respectively) will serve as an index of the change in the severity of global eating disorder symptoms accounted for by each intervention.

  2. Change in severity of clinical depression symptoms due to intervention phases [ Time Frame: Protocol day 0, 12, and 22 ]
    Participants will complete a self-report measure of depressive symptoms (the Center for Epidemiological Studies Depression scale - Revised; Eaton et al., 2004) at laboratory visits as secondary, aggregate measure of clinical change in depression symptoms. Twenty items are rated on a 0 to 4 scale, with higher scores indicating more severe depressive symptoms. The change in this score between baseline (protocol day 0) and following each light phase (protocol days 12 and 22, respectively) will serve as an index of the change in the severity of clinical depressive symptoms accounted for by each intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female sex
  2. Age of at least 18 years
  3. Minimally normal body weight (BMI ≥ 18.5 kg/m2)
  4. Clinically significant binge eating (i.e., ≥ 2 binge-eating episodes/week over the previous 3 months
  5. Clinically significant eating disorder-related impairment (indicated by a score of > 16 on the Clinical Impairment Assessment)

Exclusion Criteria:

  1. Receiving psychotherapy or psychotropic medication for the 6 weeks prior to study entry.
  2. Presence of medical conditions or medications that result in changes in hormone function, weight or appetite.
  3. Lifetime presence of bipolar disorder.

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): NCT03680989


Contacts
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Contact: Kyle P De Young, PhD 307-314-2233 kyle.deyoung@uwyo.edu
Contact: Farrell Rapp 307-766-2047 fgraf@uwyo.edu

Locations
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United States, Wyoming
University of Wyoming Recruiting
Laramie, Wyoming, United States, 82071
Contact: Kyle P De Young, PhD    307-223-2223    kyle.deyoung@uwyo.edu   
Sponsors and Collaborators
University of Wyoming

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Responsible Party: Kyle Patrick De Young, Assistant Professor of Psychology, University of Wyoming
ClinicalTrials.gov Identifier: NCT03680989     History of Changes
Other Study ID Numbers: 20180706KD02033
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
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
Bulimia
Binge-Eating Disorder
Chronobiology Disorders
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Nervous System Diseases