Brief Strategies for Improving Health Outcomes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- enrollment
研究概览
简要总结
Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common. They are also associated with depression and disordered eating, predictors of early mortality. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling distressing memories, like NEREAs, and generating ideas for bringing support into these memories. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The current study examined the feasibility and acceptability of a remote-delivered, single session of IR in a community sample of men and women with NEREAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years old
- •endorse a history of at least one negative experience related to eating and/or appearance
排除标准
- •endorsed a current major medical condition;
- •met criteria for a full threshold psychiatric disorder (of moderate intensity when severity ratings are necessary, such as for substance use disorders and binge eating disorder);
- •were at high risk for suicide;
- •endorsed current or recent pregnancy or anticipated becoming pregnant within the next year;
- •were taking medication known to affect eating, weight and/or chronic disease risk;
- •were participating in eating, weight, or diabetes programming;
- •experienced weight loss > 10% in the past six months; and/or
- •could not complete study procedures in English.
研究组 & 干预措施
Imagery rescripting
This condition has three stages. In the first stage, participants were asked to select their most distressing memory related to their appearance (not physical or sexual trauma). They were asked to visualize the selected memory, in detail, as if it were happening to them again. Then, interventionists used a downward arrow technique to identify two-to-three maladaptive core schema. In the second stage, participants were asked to identify a real or imagined trusted adult. Then, they were asked to imagine what their younger self might need to cope with or feel calmer in the situation of their selected memory. In the third stage, the participant was instructed to imagine asking the trusted adult for what they need and to imagine the trusted adult providing their selected interventions and describe how they feel afterwards. These procedures were then repeated with participants' most distressing memory related to eating. This session was remote delivered via Zoom.
干预措施: imagery rescripting (Behavioral)
Nutrition education control
The active control condition consisted of a time- and attention-matched general nutrition education session. The curriculum for this intervention included information from the United States Department of Agriculture's Dietary Guidelines (e.g., food labels, describing the benefits of macronutrients). This session was remote delivered using Zoom.
干预措施: nutrition education (Behavioral)
结局指标
主要结局
enrollment
时间窗: once, at baseline, over the duration of recruitment to obtain the sample size of interest
the total number of participants enrolled in the study and a demographic description of these participants, including their sex, gender, race, ethnicity, age and body mass index
fidelity
时间窗: during the intervention session only
the % of intervention curriculum the interventionists cover during their intervention session as rated by research staff using a curriculum checklist
data collection completeness
时间窗: baseline, intervention, 1-month, and 3-month
% of missing data collected at all study visits
intervention acceptability
时间窗: these data will be collected during the 1-month follow-up visit
captured via self-report survey items created by the researchers; participants were asked questions such as the extent to which they liked engaging in the intervention; response options are on a Likert-type scale ranging from strongly agree to strongly disagree; average scores at the item level will be generated by condition
safety
时间窗: these data will be collected during and between all study visits, from baseline though the 3-month follow-up visit
frequency of adverse events
retention
时间窗: from baseline through the 3-month follow-up visit
the % of participants retained at each visit relative to baseline (i.e., percentage of total enrolled who attended the intervention visit, the 1-month follow-up visit, and the 3-month follow-up visit)
次要结局
未报告次要终点