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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06381037
Other study ID # PID2021-127986OB-I00
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date August 31, 2026

Study information

Verified date March 2024
Source CEU San Pablo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors.


Description:

The intervention program "How to improve your strengths and quality of life" consists of 8 individual sessions. The sessions take place weekly, so the total duration of the program is 8 weeks. Each session lasts approximately 1 hour. The sessions will be held both in person and online. Following the principles of the psychoeducational therapy and Positive Psychology, this program is focused on the enhancement of personal strengths and quality of life of the elderly. Specifically, during the sessions, the following topics will be worked on: resilience, gratitude, acceptance, family functioning and quality of life in its different dimensions (control, autonomy, pleasure and self-fulfillment).


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date August 31, 2026
Est. primary completion date January 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Be at least 60 years of age. - Residing in Spain. - Not having a diagnosed neurological disease or severe psychopathological disorder, or other ailment that is incompatible with the understanding of the questionnaires or the intervention program. - Acceptance and signature of the informed consent. Exclusion Criteria: - Do not comply with the established age range. - Present an ailment that makes them unable to respond to the questionnaire.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
"How to improve your strengths and quality of life".
The intervention program "How to improve your strengths and quality of life" consists of 8 individual sessions. The sessions take place weekly, so the total duration of the program is 8 weeks. Each session lasts approximately 1 hour. The sessions will be held both in person and online. The sessions are: Session 1: Introduction to quality of life and personal strengths. Session 2: Self-fulfillment. Session 3: Pleasure. Session 4: Autonomy and control. Session 5: Family functioning and assertive communication. Session 6: Resilience. Session 7: Experiential acceptance. Session 8: Gratitude and closing of the workshop.

Locations

Country Name City State
Spain San Pablo CEU University (Campus Montepríncipe) Alcorcón Madrid

Sponsors (1)

Lead Sponsor Collaborator
CEU San Pablo University

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life Quality of life will be evaluated with Quality of Life Questionnaire for the Elderly (CASP-12)
Scale values: 1 (sometimes), 2, 3, 4 (never).
Interpretation: the higher the score, the greater the quality of life of the person being assessed.
Through study completion, and average of 4 years.
Primary Psychological wellbeing Psychological wellbeing will be evaluated with Ryff's Psychological Wellbeing Scale.
Scale values: 1 (very inadequate to describe me), 2 (quite inadequate to describe me), 3 (some inadequate to describe me), 4 (some adequate to describe me), 5 (quite adequate to describe me), 6 (very adequate to describe me).
Interpretation: the higher the score, the greater the psychological wellbeing of the person being assessed.
Through study completion, and average of 4 years.
Primary Loneliness Loneliness will be evaluated with Three-Item Loneliness Scale.
Scale values: 1 (hardly ever, 2 (some of the time), 3 (often).
Interpretation: the higher the score, the greater the loneliness of the person being assessed.
Through study completion, and average of 4 years.
Primary Anxiety and depression Anxiety and depression Anxiety and depression will be evaluated with Hospital Anxiety and Depression Scale.
Scale values: values 2-4. The meaning of the values are different for each item.
Interpretation: the higher the score, the greater the anxiety and depression of the person being assessed.
Through study completion, and average of 4 years.
Primary Gratitude Gratitude will be evaluated with the short form of the Values in Action Inventory of Strengths (VIA-IS).
Scale values: 1(very different from me), 2 (somewhat different from me), 3 (neutral), 4 (somewhat similar to me), 5 (very similar to me).
Interpretation: the higher the score, the greater the gratitude of the person being assessed.
Through study completion, and average of 4 years.
Primary Experiential acceptance Experiential acceptance will be evaluated with the Acceptance and Action Questionnaire II.
Scale values: 1(never true), 2 (very seldom true), 3 (seldom true), 4 (sometimes true), 5 (frequently true), 6 (almost always true), 7 (always true).
Interpretation: the higher the score, the greater the experiential acceptance of the person being assessed.
Through study completion, and average of 4 years.
Primary Resilience Resilience will be evaluated with the Brief Resilient Coping Scale (BRCS).
Scale values: 1(it does not reflect a typical reaction in my), 2, 3, 4, 5 (it does reflect a typical reaction in my).
Interpretation: the higher the score, the greater the resilience of the person being assessed.
Through study completion, and average of 4 years.
Primary Family functioning Family functioning will be evaluated with the APGAR familiar.
Scale values:0 (never), 1 (rarely), 2 (sometimes), 3 (almost always), 4 (always).
Interpretation: the higher the score, the greater the family functioning of the person being assessed.
Through study completion, and average of 4 years.
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