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

NCT03680989 | Completed

• 1 other identifier: 20180706KD02033
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder; Binge Eating; Circadian Dysregulation

Outcome Measures

Primary Outcomes (3)

• Change in the Cortisol Awakening Response

  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.

  Assessed at baseline (days 1 and 2) and after each intervention (days 10 and 11 and days 21 and 22)

• Change in Binge Eating (i.e., degree of loss of control over eating)

  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.

  Multiple ratings per day for 22 days

• Change in Momentary Negative Mood

  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.

  Multiple ratings per day for 22 days

Secondary Outcomes (2)

• Change in severity of global eating disorder symptoms due to intervention phases

  Protocol day 0, 12, and 22

• Change in severity of clinical depression symptoms due to intervention phases

  Protocol day 0, 12, and 22

Study Arms (2)

Natural Light

PLACEBO COMPARATOR

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

Bright Light

ACTIVE COMPARATOR

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

Interventions

Bright Light Exposure DEVICE

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".

Bright Light

Natural Light Exposure DEVICE

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".

Natural Light

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wyoming: lead

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperphagia; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 21, 2018
• Study Start: February 15, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)