Preventing Type 2 Diabetes Through Using Acceptance and Commitment Therapy Principles to Target Illness Perceptions and Controllability Awareness in Educational Materials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Brief Illness Perceptions Questionnaire
研究概览
简要总结
The investigators will evaluate whether a brief intervention (i.e. a workbook and video presenting educational information and activities materials for diabetes prevention) that incorporates principles drawn from focused Acceptance and Commitment Therapy frameworks impact positive and negative affect, stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, stress, diabetes distress, weight stigma internalization, controllability awareness, psychological flexibility, and self-efficacy - compared to standard diabetes prevention education materials.
详细描述
The investigators aim for this study to represent community-based, participatory research which is accessible, effective, understandable, and minimizing of stigma. Prior to conducting the study, the investigators will develop a community advisory board, consisting of practitioners who have expertise with the development and delivery of the intervention material and study population. Advisory board members will review the study materials and provide feedback for refining the study via meetings with the Principle Investigator. In addition, the investigators will hold a focus group composed of members of the community who have prediabetes or Type 2 Diabetes and who are interested in contributing to the study design. The focus group participants will review the study materials and provide feedback for improvement in understandability, minimizing stigma, effectiveness, access and relatability to the general public. Content from the community advisory board meetings and focus group will be used to inform the study design and will not be used for dissemination of data.
For the study implementation, the investigators will distribute online questionnaires on Amazon's Mechanical Turk and use CloudResearch service to recruit participants and manage the online project. Amazon's Mechanical Turk hosts research opportunities, called Human Intelligence Tasks, to online "workers". To distribute our surveys to this participant pool the investigators will embed our Qualtrics survey link in each Human Intelligence Tasks. The description of study purpose, time commitment, and research method will be available to the online "workers" who meet the inclusion criteria set on CloudResearch.
Participants will be assessed for eligibility (see below) via a qualtrics survey sent via Amazon Mechanical turk. As the eligibility process screens for risk of diabetes and assesses perceived stress, socioeconomic indicators, health status, and state anxiety, participants will also complete an initial consent form prior to eligibility screening. This process generates three distinct participant groups: study 1 ("Randomized Control Trial"), study 2 ("Cross-Sectional") and study 3 ("Sub-study"). The summary of measures given to each group is outlined in Table 1 below.
Study 1 ("Randomized Control Trial"): Participants will complete "pre-intervention measures" to assess individual differences (diabetes risk, diabetes program prevention participation, socioeconomic status, subjective social standing, co-morbidities, health status, illness perceptions, self-efficacy, and perceived stress). Participants will be randomized into either a brief standard diabetes education intervention or a brief diabetes education and acceptance and commitment therapy intervention. Acceptance and Commitment Therapy-informed materials will retain facts about the condition, but will modify health messaging (adapted from the Center for Diseases Control and Prevention's National Diabetes Prevention Program) to clarify common inaccurate illness perceptions, reduce body size discrimination, and encourage psychological flexibility through framing illness perceptions, controllability awareness (i.e. ability to distinguish modifiable from unmodifiable components), non-judgmental awareness of what is occurring, willingness to allow experiences to occur, and the ability to step back from cognitions, acting according to personal values. Following, participants will complete "post-intervention measures" to assess psychosocial variables (i.e. stress perceptions, treatment expectations and intentions to engage, motivation and activation, illness perceptions, acute stress, diabetes distress, diabetes locus of control, self-efficacy, controllability awareness, psychological flexibility, and self-efficacy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •United States Residency
- •90% or higher Human Intelligence Task completion ratings (ratings which are assigned by mTurk researchers to workers upon completion of a Human Intelligence Task , and to indicate quality of worker history with mTurk).
- •At least 18 years of age
- •English-speaking
- •High-risk for Type 2 Diabetes, as indicated by a score of 5 or greater on the American Diabetes Association's diabetes risk test.
排除标准
- •Having been enrolled in a lifestyle program for diabetes prevention presently or within the past year.
- •Type 1 Diabetes diagnosis
- •Type 2 Diabetes diagnosis
结局指标
主要结局
Brief Illness Perceptions Questionnaire
时间窗: Directly following the intervention
The Brief Illness Perceptions Questionnaire is a 9-item survey to rapidly assess the cognitive and emotional representations of illness tailored to focus on illness perceptions regarding diabetes risk. There are 5 items to measure cognitive representation of illness perceptions: consequences, timeline, personal control, treatment control, identity; two items to measure emotional representation: concern and emotional response; one item to measure illness comprehensibility / understanding; and one item designed to assess causal representation which asks participants to "rank-order the three most important factors that \[the participant\] believe caused \[the participants\] diabetes risk." Responses for the first 8 items are collected on an eleven-point Likert scale (e.g. Not at all affected emotionally (0) to Extremely affected emotionally (10)), where higher scores reflect a more extreme illness perception. Causal representation is an open-ended response.
Expected Program-Related Controllability Awareness Scale
时间窗: Directly following the intervention
The Expected Program-Related Controllability Awareness Scale was created to measure ''controllability awareness',": how much an individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. . Participants are provided a description of controllability awareness and then about the degree to which they agree with the statement "A diabetes prevention program like this one would help me prevent diabetes by teaching me to pay attention to the things about my situation that I can change and the things about my situation that I cannot change". Subjects indicate how much they agree or disagree with the statement on a 5-point scale from 1 = disagree strongly to 5 = agree strongly, where higher scores reflect higher controllability awareness.
(Modified) Brief Diabetes Risk-Related Distress
时间窗: Directly following the intervention
The Diabetes Risk Distress Scale is a 5-item survey designed to measure patient concerns about diabetes prevention efforts and emotional burden of diabetes risk. The scale is modified for use in populations at high-risk of developing diabetes from the Brief Diabetes Distress Scale, with the inclusion of an additional item from the original 17-item Diabetes Distress Scale . Responses are collected using a 6-point likert scale ranging from "Not a problem" (1) to "A Very Serious Problem" (6), with higher scores reflecting higher levels of diabetes distress. Two subscales will also be considered: emotional burden and diabetes distress.
Expected Diabetes Prevention-Related Controllability Awareness Scale
时间窗: Directly following the intervention
The Expected Diabetes Prevention-Related Controllability Awareness Scale is a 20- item survey designed to measure ''controllability awareness,": the extent to which the individual's behavioral and emotional responses to daily life situations reflect awareness of the controllable and uncontrollable aspects of the outcomes of those situations without focusing explicitly on controllability distinctions. The inventory was developed to assess controllability awareness as a characteristic of stress tolerance. The inventory consists of 20 simple statements assessing awareness of various aspects of controllability including personal control, shared control, others in control, and no one in control. Subjects indicate how much they agree or disagree with each statement from 1 = disagree strongly to 5 = agree strongly. Scores from all items are summed for a scoring running from 20-100, where higher scores reflect higher levels of controllability awareness.
Phenomenological Body Shame Scale - Revised
时间窗: Directly following the intervention
The Phenomenological Body Shame Scale - Revised is an 8 item survey derived from the original 18 item Phenomenological Body Shame Scale designed to measure the motivational and behavioral components of experiencing shame when participants imagine looking at themselves in a mirror, such as the desire to hide, escape, or disappear. Sample statements include "These diabetes education materials made me feel like covering my body." and "These diabetes education materials made me wish I were invisible." and are measured on a 5 point likert scale ranging from "not at all" scored as 1 to "extremely" scored as 5. Possible scores range from 8 to 40 with higher scores reflecting higher body shame.
Personalized Psychological Flexibility Index-Diabetes Prevention
时间窗: Directly following the intervention
The Personalized Psychological Flexibility Index-Diabetes Prevention is a 15-item survey designed to measure the ability to pursue valued life aims despite the presence of distress, which is a fundamental contributor to health. The index measures tendencies to avoid, accept, and harness discomfort during valued goal pursuit. For this study, we modified the scale to tailor the wording to goals related to diabetes prevention. In this study, three subscales are calculated: Avoidance subscale, Acceptance subscale, and Harnessing subscale. Items are measured on a 7 point likert scale of "strongly disagree" (1) to "strongly agree" (7). Psychological flexibility scores are computed by summing all items and range from 15-105, with higher scores reflecting more challenge in pursuing valued life goals despite presence of distress.
Brief Health Belief Model
时间窗: Directly following the intervention
The Brief Health Belief Model measure is designed to assess patient beliefs about the perceived seriousness ("If someone had Type 2 Diabetes or another related disease (such as stroke or heart disease), their whole life would change"), perceived susceptibility ("It is likely that I will get Type 2 Diabetes or another related disease (such as stroke or heart disease"), perceived prevention program benefits ("If I do a lifestyle change program for diabetes prevention it will decrease my chances of getting Type 2 Diabetes"), confidence ("I am confident that I could do what is recommended in the Diabetes Prevention Program if I wanted to"), and health motivation ("Maintaining good health is extremely important to me"). Each item is scored from 1 to 5 based on a Likert scale: "I strongly disagree" (1 point), "I disagree" (2 points), "I am not sure" (3 points), "I agree" (4 points), and "I strongly agree" (5 points).
次要结局
- Short-form State-Trait Anxiety Inventory(Directly following the intervention)
- (Modified) 3-item Positive and Negative Affect(Directly following the intervention)
研究者
Megan Lipsett
Principal Investigator
University of Oregon