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临床试验/NCT03680989
NCT03680989已完成不适用

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

University of Wyoming2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change in the Cortisol Awakening Response

研究概览

简要总结

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.

详细描述

Women (N = 30) who are at least 18 years of age with minimally normal body weight (BMI ≥ 18.5 kg/m2) and exhibit clinically significant binge eating (BE; ≥ 2 BE episodes/week over the previous 3 months) and clinically significant impairment will be eligible to participate. Binge eating will be defined as described in the DSM-5: consuming an objectively large amount of food in a discrete period of time while experiencing a sense of loss of control over eating. The minimum frequency of 2 BE episodes/week will prevent a statistical floor effect from making decreases in BE frequency too small to reliably detect. Further, this frequency should ensure that a sufficient number of BE events occur during the sampling period. A nontreatment-seeking sample is appropriate because the vast majority of individuals with eating disorders do not seek treatment (e.g., 6% of individuals with bulimia nervosa receive mental health services per year).

Participants will be recruited from the community using advertisements (e.g., flyers, newspaper ads, listservs, social media). Advertisements will inform interested individuals that they can complete a brief online or phone-based eligibility screen. Individuals who appear eligible on the online screen will be called by a trained research assistant to confirm the screening results. Thus, all prospective participants will be screened by a trained research assistant over the phone. The eligibility screen is modeled off an existing validated tool (i.e., the Eating Disorder Diagnostic Scale) that is modified to assess specific inclusion/exclusion criteria.

Individuals will be excluded for several factors that impact hormone function, weight, or appetite or may result in changes in binge eating, including medical conditions and/or medication use in the past 6 weeks months and underweight status, or receiving psychotherapy or psychotropic medication for the 6 weeks prior to study entry. In addition, individuals for whom engaging in the manipulation may be dangerous (e.g., those with diabetes or bipolar disorder) will be excluded. Individuals who appear to meet study eligibility based on the telephone screening and are interested in participating will be scheduled for their baseline appointment.

Baseline Assessment The baseline appointment will begin by obtaining informed consent. Participants will be informed of their rights as research participants, the foreseeable risks involved in participation, expected benefits, and other relevant issues (e.g., remuneration schedule).Body Mass Index (BMI) will be assessed via height and weight measured with a stadiometer and digital scale. Inclusion/exclusion criteria will be confirmed via clinical interviews: Eating Disorders Examination (EDE) and Structured Clinical Interview for DSM-5 Axis I disorders (SCID-I). The EDE will be used to confirm current eating disorder symptoms and diagnoses. The SCID-I will be used to assess lifetime history of an eating disorder, and current and lifetime presence of other Axis I disorders that frequently co-occur with eating disorders. The SCID interview will also be used to assess exclusion criteria (e.g., bipolar disorder). Interviews will conducted by doctoral students in clinical psychology who are equivalent to master's degree level mental health professionals. They will be trained by the PI. Their interviews will be audio recorded to assess interrater reliability. Participants will also complete baseline self-report measures at this visit. These include the Clinical Impairment Assessment, the Change in Eating Disorder Symptoms scale, the Pittsburgh Sleep Quality Index, the Center for Epidemiological Studies Depression scale - Revised, the Positive and Negative Affect Schedule, and Subjective Appetite Scales. Prior to leaving this baseline appointment, research assistants will train participants on the use of the therapy light box, the Actiwatch device, and on the proper collection of saliva samples, and they will explain what appointment reminders participants should expect, in addition to querying their preferred method of reminder delivery (e.g., phone call, text, or email).

Ecological Momentary Assessment (EMA) At the first day of the 22-day sampling period, EMA data collection will begin to capture daily eating patterns and subjective loss of control during eating and negative mood. Signal-contingent ratings will be semi-randomly sampled six times per day during waking hours. These will assess the strength of negative mood. These ratings will be made when the Actiwatch device alerts participants by vibrating that a rating is being requested. These assessments take only a moment to complete using an ordered rating scale. Participants will also be asked to complete ratings following eating episodes (Event-contingent ratings). They will indicate the extent of loss of control experienced and the strength of negative mood. These data will allow the investigators to evaluate daily patterns in the timing of eating and rates of dysregulated eating episodes. All ratings provided (i.e., regardless of the type of EMA sampling schedule) are time stamped, so that reports cannot be retrospectively completed or backdated. Data are saved locally to the device and are downloaded when participants return the device to the lab.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

结局指标

主要结局

Change in the Cortisol Awakening Response

时间窗: 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.

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

时间窗: 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.

Change in Momentary Negative Mood

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyle Patrick De Young

Assistant Professor of Psychology

University of Wyoming

研究点 (2)

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