Program to improve the quality of life due to unwanted loneliness in widowed women. Nature, an ally to accompany you
| ISRCTN | ISRCTN15668430 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15668430 |
| Secondary identifying numbers | Protocolo 1 |
- Submission date
- 10/07/2024
- Registration date
- 12/02/2025
- Last edited
- 12/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This project aims to combine tourism with the unique features of the Jerte Valley as a therapy to combat loneliness. It involves a series of nature-based activities that will position the Jerte Valley as a specialized tourist destination in therapeutic tourism, understood as tourism that aims to improve and maintain general health and specifically address loneliness, enhancing aspects that are impacted by this situation, such as quality of life, self-concept, resilience, etc. Particularly, this project addresses the issue of unwanted solitude among elderly widowed women, recognizing solitude in women as one of the social problems with the highest incidence and risk of social isolation, worsening the morbidity and mortality among women. Through a program of nursing interventions with other health agents and specialists in loneliness, we have developed a multi-component program based on therapeutic tourism. The main objectives of the presented project are to conduct a pilot experience of therapeutic tourism in the Jerte Valley and to analyse the efficacy of a multi-component program that combines nursing interventions, support from loneliness specialists, social anthropology, and psychology, along with nature activities, to foster socialization and improve the quality of life for these women. Lastly, the expected results of the program are the implementation of a pilot experience of therapeutic tourism in the Jerte Valley that could be generalizable to other vulnerable groups requiring special attention to the recovery of socialization. The study will involve the dissemination, in scientific, and cultural forums, and to the national loneliness observatory, of the program's efficacy.
Who can participate?
Women between the ages of 60 and 85 years old who live independently in the community and have feelings of loneliness
What does the study involve?
This study will:
SO1: Evaluate the variables of loneliness, despair, and quality of life before the intervention of the control group and the experimental group to establish the baseline.
SO2: Nursing interventions with emotional support in the experimental group over 6 weekends, with the first four weekends being consecutive, taking a break on the fifth weekend, and then resuming for two more consecutive weekends, totaling 48 hours of interventions received by the end of the program.
SO3: Assess the variables of loneliness, despair, and quality of life after the completion of the intervention program.
SO4: Evaluate the intervention variable in both groups (control and experimental) one month after the intervention's completion to analyze the long-term maintenance of the results.
SO5: Disseminate the pilot experience of therapeutic tourism in the Jerte Valley through Conferences on therapeutic tourism in the Jerte Valley and the prevention of unwanted loneliness, reporting of scientific articles, and a documentary of the experience.
What are the possible benefits and risks of participating?
Benefits include being able to socialize as well as create support networks, and tools to combat loneliness and increase the quality of life. The study does not involve risks, the accompaniment of these women is fundamental, the group of professionals who will develop the interventions are trained to accompany and resolve any situation that may arise.
Where is the study run from?
University of Extremadura
When is the study starting and how long is it expected to run for?
January 2024 to September 2024
Who is funding the study?
The Diputación de Cáceres
Who is the main contact?
Belinda Basilio Fernández, bbasfer@unex.es
Contact information
Public, Scientific, Principal Investigator
-
Plasencia
10600
Spain
 ORCID ID |
0000-0003-3756-9586 |
|---|---|
| Phone | +34649320344 |
| bbasfer@unex.es |
Study information
| Study design | Prospective cohort randomized controlled trial (RCT) with a mixed approach |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Home |
| Study type | Quality of life |
| Participant information sheet | 45767_PIS.pdf |
| Scientific title | A multicomponent program to improve the quality of life of widowed women with unwanted loneliness: a study protocol for a pilot randomized controlled trial |
| Study objectives | Multicomponent intervention to improve the quality of life in widowed women with unwanted loneliness |
| Ethics approval(s) |
Approved 21/03/2024, Bioethics and Biosecurity Commission of The University of Extremadura (Comisión de Bioética y Bioseguridad de la Universidad de Extremadura) (C/ Elvas s/n., Badajoz, 06006, Spain; +34 924289300; irocha@unex.es), ref: 46/2024 |
| Health condition(s) or problem(s) studied | Quality of life related to unwanted loneliness in widows |
| Intervention | 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 standard deviation of the UCLA Loneliness Scale-Revised standard deviation of the UCLA Loneliness Scale-Revised (UCLA LS-R) in women over 65 years of age. Because no studies defined the minimum clinical change it has been set at 4 points, it would require a minimum of 25 participants per group (50 in total) with a power of 80%, an α value of 0.05 and an estimated loss rate of 20%. To perform this calculation, an online sample calculator an online sampling calculator was used to perform this calculation. A member of the research team who will not be directly involved in the trial will create a simple computer-generated randomization sequence using Research Randomizer software (Version 4.0, Urbaniak GC and Plous S., Middletown, CT, USA; 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 (experimental or control). Intervention Both the experimental group (regular users + multicomponent program) and the control group (regular users) will undergo pre-intervention, post-intervention and follow-up phases for 1 month. The difference between the two groups lies in the fact that the participants in the experimental group will be the only ones who will undergo the intervention based on a multicomponent psychosocial program. The intervention program will be composed of 6 sessions that will be carried out on 4 continuous weekends beginning in April. They will consist of outings to the Jerte Valley to participate in therapeutic tourism. The sessions will be divided into a therapeutic component (first part of the session) with at least two members of the team and up to 4 maximum, who are professionals in the field of nursing, with experience in the field of bereavement and work with women. The second component of the session (second part of the part of the session) will be focused on the realization of sports in nature led by experts in the field and supported by the team and its accompaniment. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | Interpretation of the participant's change in quality of life will be measured using the interview transcriptions during the study's qualitative research |
| Overall study start date | 01/01/2024 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Upper age limit | 85 Years |
| Sex | Female |
| Target number of participants | Two groups. Intervention group and control group. (2:1) 25 participants per group (50 in total) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/02/2024 |
| Date of final enrolment | 21/03/2024 |
Locations
Countries of recruitment
- Spain
Study participating centre
Plasencia
10600
Spain
Sponsor information
University/education
C/Elvas s/n
Badajoz
06006
Spain
| Phone | +34 924289300 |
|---|---|
| vrinvestigacion@unex.es | |
| Website | https://www.unex.es/organizacion/gobierno/vicerrectorados/viceinves |
"ROR" |
https://ror.org/0174shg90 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 13/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in a peer-reviewed journal 2. International Conference on unwanted loneliness in widowed women in Extremadura |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 11/07/2024 | No | Yes |
Additional files
Editorial Notes
12/09/2024: Study's existence confirmed by the Bioethics and Biosecurity Commission of The University of Extremadura. The Commission had permitted the study to start recruiting before it could communicate full ethics approval officially.
