A protocol for a wait list control trial of an intervention to improve pain and depressive symptoms among middle-aged and older women living with disabilities

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-01-28 DOI:10.1016/j.cct.2025.107826

Janiece L. Taylor , Catherine A. Clair , Shelbie Atkins , Claire Wang , Ashley Booth , M. Carrington Reid , Elaine Wethington , Natalie G. Regier

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Abstract

Background

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.

Purpose

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).

Methods

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.

Conclusion

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.

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一项改善中老年残疾妇女疼痛和抑郁症状的干预措施的等候名单对照试验方案。

背景：老年残疾妇女慢性疼痛和并发抑郁症状的发生率高于无残疾妇女和有残疾和无残疾男子。疼痛和抑郁会加重残疾妇女履行社会角色和完成日常生活活动的能力。虽然已有针对疼痛和抑郁症状的干预措施，但针对老年残疾妇女的治疗慢性疼痛和抑郁症状的干预措施很少。目的：本研究的目的是确定妇女在疼痛减轻和改善情绪通过授权（PRIME）干预的可接受性和可行性的样本生活的中老年妇女疼痛，抑郁症状和身体残疾（即行动障碍）。方法：在这项等待名单随机对照试验中，我们将通过确定招募率和保留率来评估干预措施的可行性；2)通过对所有入组参与者的定性访谈，可接受性；3)通过确定立即干预和候补对照参与者之间疼痛和抑郁症状的变化来估计效果大小，为未来的研究提供信息。结论：这种干预有两个主要组成部分，有可能减少疼痛和抑郁症状，从而提高生活质量。临床试验的设计和结构必须考虑到中心残疾妇女的伙伴关系和需求。该试验已注册在clinicaltrials.gov, NCT05619510, 11/09/2022。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.