Taylor Janiece L, Clair Catherine A, Atkins Shelbie, Wang Claire, Booth Ashley, Reid M Carrington, Wethington Elaine, Regier Natalie G
Johns Hopkins School of Nursing, Baltimore, MD, United States of America.
Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.
Contemp Clin Trials. 2025 Mar;150:107826. doi: 10.1016/j.cct.2025.107826. Epub 2025 Jan 28.
Women aging with disabilities experience higher rates of chronic pain and co-occurring depressive symptoms than women without disabilities and men with and without disabilities. Pain and depression can exacerbate the inability to fulfill social roles and complete activities of daily living among women with disabilities. Although there are existing interventions for both pain and depressive symptoms, few interventions have been developed with women aging with disabilities that address both chronic pain and depressive symptoms.
The aim of this study is to ascertain the acceptability and feasibility of the Women in Pain Reduction & Improved Mood through Empowerment (PRIME) intervention in a sample of middle-aged and older women living with pain, depressive symptoms, and physical disabilities (i.e., mobility disability).
In this wait-list, randomized controlled trial we will assess the intervention's 1) feasibility by determining recruitment and retention rates; 2) acceptability through qualitative interviews with all enrolled participants; and 3) preliminary efficacy by determining changes in pain and depressive symptoms between immediate intervention and waitlist control participants to estimate effect sizes to inform future research.
This intervention has two main components, which have the potential to decrease pain and depressive symptoms and lead to increased quality of life. It is imperative that clinical trials are designed and structured with the partnership and needs of women with disabilities at the center. This trial is registered at clinicaltrials.gov, NCT05619510, 11/09/2022.
与无残疾女性以及有残疾和无残疾男性相比，残疾老年女性患慢性疼痛和并发抑郁症状的比例更高。疼痛和抑郁会加剧残疾女性履行社会角色和完成日常生活活动的能力障碍。尽管现已有针对疼痛和抑郁症状的干预措施，但很少有专门为残疾老年女性开发的、能同时解决慢性疼痛和抑郁症状的干预措施。
本研究旨在确定“通过赋权减轻疼痛、改善情绪的女性（PRIME）”干预措施在患有疼痛、抑郁症状和身体残疾（即行动不便）的中老年女性样本中的可接受性和可行性。
在这项等待名单随机对照试验中，我们将评估该干预措施的：1）可行性，通过确定招募率和保留率；2）可接受性，通过对所有登记参与者进行定性访谈；3）初步疗效，通过确定立即干预组和等待名单对照组参与者之间疼痛和抑郁症状的变化，以估计效应大小，为未来研究提供信息。
该干预措施有两个主要组成部分，有可能减轻疼痛和抑郁症状并提高生活质量。必须以残疾女性的伙伴关系和需求为中心来设计和构建临床试验。该试验已在clinicaltrials.gov上注册，NCT05619510，2022年11月9日。
