一项针对饮食和外表负面体验的主要后果的单次图像重新描述的随机试验的可行性和可接受性。

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Nichole R Kelly, Kelly Jean Doty, Bonnie H C Schrag, Shaylah Bryant, Sammy Plezia, Nicholas J Parr, Elizabeth L Budd
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引用次数: 0

摘要

背景:与饮食和外表相关的负面经历(nerea),如父母对食物的批评,是常见的,与抑郁和饮食失调有关。意象重写(IR)是一种治疗过程,在此过程中,个体被引导通过回忆和为痛苦记忆提供支持,如nerea。在女性临床样本中,单次IR治疗有望改变nerea的主要负面影响。该试点试验的主要目的是评估远程提供的单次IR和营养教育对照组在nerea成人社区样本中的可行性和可接受性。方法:在这项平行的双臂试验中,参与者于2023年2月至2024年4月在美国俄勒冈州完成了一次亲自基线访问,一次远程交付的单次干预(IR或注意匹配营养教育控制),以及1个月和3个月的亲自随访。可行性指标包括招募、访问和调查完成率以及干预保真度;使用参与者反馈和不良事件实例来评估可接受性。结果:101名成年人完成了电话筛查;96%报告了至少一次NEREA。这些成年人中的大多数不符合资格,因为他们符合精神障碍标准和/或正在服用已知会影响情绪和/或食欲的药物。32名参与者完成了基线研究访问;89%的参与者(N = 27;平均年龄[SD] = 32.52[15.78],范围= 18-73;56%为顺性别女性;74.1%的非西班牙裔白人、14.8%的亚洲人、11.1%的西班牙裔/拉丁人、7.4%的黑人和3.7%的多种族)被随机分配(使用随机数生成器)到并完成干预条件(IR 13, control 14)。平均而言,IR组的课程依从性为94%,对照组为97%。1个月留存率为82%,3个月留存率为59%。干预后评分显示两组患者的可接受性良好。无不良事件发生。结论:提供的干预措施对社区男性和女性样本是可行和可接受的;因此,建议将来进行一次明确的试验。需要额外的策略来提高留存率。像IR这样的单次干预措施具有高影响和覆盖面的潜力。它们本质上是灵活和具有成本效益的干预措施,可以跨医疗系统提供,而远程提供则减轻了对耻辱和可及性的担忧。试验注册:ClinicalTrial.gov, NCT06610318。于2024年9月23日注册-追溯注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Feasibility and acceptability of a pilot randomized trial of a single session of imagery rescripting targeting the primary consequences of negative experiences with eating and appearance.

Background: Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common and associated with depression and disordered eating. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling and bringing support into distressing memories, like NEREAs. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The primary objectives of this pilot trial were to evaluate the feasibility and acceptability of a remote-delivered, single session of IR and a nutrition education control group in a community sample of adults with NEREAs.

Methods: In this parallel two-arm pilot trial, participants completed an in-person baseline visit, one remote-delivered, single-session intervention (IR or attention-matched nutrition education control), and in-person 1- and 3-month follow-up visits between February 2023 and April 2024 in Oregon, USA. Markers of feasibility included recruitment, visit and survey completion rates, and intervention fidelity; acceptability was evaluated using participant feedback and instances of adverse events.

Results: One hundred one adults completed a phone screen; 96% reported at least one NEREA. Most of these adults were ineligible because they met psychiatric disorder criteria and/or were taking medication known to influence mood and/or appetite. Thirty-two participants completed a baseline study visit; 89% of these participants (N = 27; mean age [SD] = 32.52 [15.78], range = 18-73; 56% cisgender women; 74.1% non-Hispanic White, 14.8% Asian, 11.1% Hispanic/Latine, 7.4% Black, and 3.7% multiracial) were randomly assigned (using a random number generator) to and completed an intervention condition (13 IR, 14 control). Curriculum adherence, on average, was 94% for IR and 97% for control. One-month retention was 82%, and 3-month retention was 59%. Post-intervention ratings indicated good acceptability for both arms. No adverse events occurred.

Conclusions: The delivered interventions are feasible and acceptable to a community sample of men and women; as such, a future definitive trial is recommended. Additional strategies for increasing retention are needed. Single-session interventions, like IR, have the potential for high impact and reach. They are inherently flexible and cost-effective interventions that can be delivered across systems of care, while remote delivery mitigates concerns with stigma and access.

Trial registration: ClinicalTrial.gov, NCT06610318 . Registered on 23 September 2024-retrospectively registered.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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