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Program to improve the quality of life due to unwanted loneliness in widowed women. Nature, an ally to accompany you

A multicomponent program to improve the quality of life of widowed women with unwanted loneliness: a study protocol for a pilot randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15668430
Enrollment
50
Registered
2025-02-12
Start date
2024-02-26
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of life related to unwanted loneliness in widows Mental and Behavioural Disorders

Interventions

This study will be carried out in the province of Cáceres, taking the population of widowed women. The sample size has been calculated using data from a previous study considering the mean and standar
http://www.randomizer.org). The assignment will be hidden with a password-protected file. Researchers involved in the data analysis processes will not know to which group each woman will be assigned (

Sponsors

University of Extremadura
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Be a woman between the ages of 60 and 85 years old 2. Living independently in the community 3. Feelings of loneliness

Exclusion criteria

Exclusion criteria: 1. Comorbidity with other mental health problems such as severe mental disorders (schizophrenia or bipolar disorders), personality disorders, dementias, and major depressions 2. Comorbidity of physical problems that prevent them from performing adventure activities in nature, such as severe musculoskeletal injuries 3. Women who do not know the Spanish language well enough to hold a conversation

Design outcomes

Primary

MeasureTime frame
The following primary outcome measures will be assessed before and after the intervention (in the control group, at the beginning and the end of the program): 1. Sociodemographic variables (age, educational level, socioeconomic status, whether living alone, etc.) measured using a sociodemographic data sheet during the study 2. Experiences regarding loneliness and the experience of the intervention measured using semi-structured interviews 3. Feeling of loneliness measured using a focus group with the experimental group 4. Loneliness measured using the University of California Loneliness Scale 5. Health status and well-being measured using the EQ5-5D-5L HRQoL (health-related quality of life) measurement instrument 6. HRQoL measured using the SF-12 7. HRQoL measured using the 5-D 8. HRQoL measured using the AQOL-8D 9. Hopelessness measured using the Beck Hopelessness Scale 10. Depression measured using the Yesavage Depression Scale 11. Physical activity during the last 7 days measured using the International Physical Activity Questionnaires (IPAQ)

Secondary

MeasureTime frame
Interpretation of the participant's change in quality of life will be measured using the interview transcriptions during the study's qualitative research

Countries

Spain

Contacts

Public ContactBelinda Basilio Fernández
bbasfer@unex.es+34649320344

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026