Multicomponent program to alleviate loneliness in widowed women: study protocol for a pilot randomized controlled trial

一项旨在缓解丧偶女性孤独感的多组分项目:一项试点随机对照试验的研究方案

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Abstract

BACKGROUND: Older adults, particularly women, face high loneliness risks due to longer lifespans and widowhood. This study aims to describe a therapeutic tourism program for widowed women experiencing loneliness in Spain’s Jerte Valley. METHODS: Using a randomized controlled trial (following CONSORT guidelines and employing mixed methods), 50 participants will be assigned (2:1 ratio) to either an intervention or a control group. Primary outcomes will assess loneliness using the De Jong Gierveld and UCLA Loneliness scales. Secondary measures include quality of life (15-D), physical activity (IPAQ), and nature connectedness (CNS). Qualitative data from video-recorded interviews will explore widowhood experiences. The intervention will involve therapeutic activities facilitated by nursing professionals experienced in grief support and mental health, alongside outdoor sports activities led by experts in physical activity. DISCUSSION: The implementation of this pilot study addresses various practical and operational challenges inherent to rural environments, such as geographical dispersion and limited resources, thereby reinforcing the design’s relevance and applicability in real-world conditions. The rigorous methodological approach and multi-component nature of the program are expected to generate valuable evidence on the effectiveness of interventions that combine contact with nature, physical exercise, and emotional support. This protocol represents an innovative, person-centered proposal with an interdisciplinary foundation, making it a promising tool for improving the emotional well-being of vulnerable widowed women and potentially replicable in other rural or community contexts. TRIAL REGISTRATION: This study was registered on 12 February 2025 in the ISRCTN Clinical Trials Register recognized by the World Health Organization (WHO) and the International Committee of Medical Journal Editors (ICMJE) (trial number: ISRCTN15668430).

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