Older PeopleNCT06671574
Emotional Intelligence and Relaxation Techniques for Mental Health and Sleep in Older Adults
A study testing Emotional intelligence and Relaxation techniques in people with Older People, run by University of Jaén at 1 site in Spain.
Trial summary
This topic highlights the role of emotional intelligence and relaxation techniques in enhancing mental health for adults over 60. Emotional intelligence, which involves understanding and managing one's emotions, can improve emotional well-being in older adults facing challenges like loneliness and anxiety. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Older People
- What is being tested?
- Emotional intelligence and Relaxation techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2024to 28 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People aged 60 years or older.
- Older adults with mental health problems, such as anxiety, stress, or mild depressive symptoms.
- Participants who report difficulty falling or staying asleep, or who have some type of sleep disorder (such as insomnia or fragmented sleep).
- People willing to participate in emotional intelligence interventions and relaxation techniques.
- Older adults who live in a stable environment (private housing, community centers, etc.) and who have sufficient cognitive abilities to understand and follow basic instructions for relaxation techniques.
Who cannot join
- People under 60 years of age.
- Older adults with serious psychiatric disorders, such as advanced dementia, schizophrenia, or uncontrolled bipolar disorder, that could interfere with effective participation in the interventions.
- Participants with serious physical health problems, such as unstable heart disease or advanced respiratory failure, that could be worsened by relaxation techniques or limit their participation.
- People who are already receiving specific treatment for sleep disorders that includes medication or intensive psychotherapeutic interventions, since these could interfere with the results of the study.
- Older adults with severe sensory limitations (such as deafness or uncorrected blindness) that prevent them from understanding or adequately performing the proposed relaxation techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional Intelligence and Relaxation Techniques in Mental Health, Sleep Disorders, and Quality of Life in Adults Over 60 Years
This topic highlights the role of emotional intelligence and relaxation techniques in enhancing mental health for adults over 60. Emotional intelligence, which involves understanding and managing one's emotions, can improve emotional well-being in older adults facing challenges like loneliness and anxiety. Sleep disorders are common in this age group and can lead to increased mental health issues such as depression. Relaxation techniques, including meditation, yoga, and deep breathing, have been shown to reduce stress and improve sleep quality. By integrating emotional intelligence and relaxation practices into daily life, older adults can enhance their overall quality of life and mental health.
- Conditions
- Older People
- Being tested
- Emotional intelligence and Relaxation techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional intelligence and Relaxation techniquesOther
In each session, participants will engage in exercises aimed at recognizing, understanding, and regulating their emotions. These interactive activities will foster personal reflection and group discussion, helping individuals identify emotions in various situations and their impact on behavior. This approach will enhance emotional awareness and equip participants with practical tools for managing stress and anxiety. Various relaxation techniques will also be introduced. Deep breathing exercises will teach participants to calm their minds and bodies, reducing tension. Guided meditation will help them focus inward, promoting mental peace and deep relaxation. Additionally, visualization exercises will encourage imagining calming scenarios, alleviating anxiety and improving overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will not receive intervention, but will receive information sessions on general health and well-being topics, such as sleep hygiene, healthy lifestyle habits and practical tips to improve rest, in order to control for the placebo effect. These information sessions will be held at the beginning of the study and will be supported by brochures and educational material. |
| Experimental Group | Experimental | This group will participate in a structured program that combines the development of emotional intelligence with relaxation techniques. It will last 12 weeks, with sessions twice a week, each lasting approximately 60 minutes. The sessions will be led by a mental health professional. During the sessions, exercises will be worked on to recognize, understand and regulate emotions, allowing participants to develop skills to better manage stress and anxiety. In addition, relaxation techniques such as deep breathing, guided meditation and visualization will be practiced, which have been shown to be effective in reducing muscle tension, lowering cortisol levels and promoting restful sleep. Receives: Other: Emotional intelligence and Relaxation techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Form-36 Health Survey (SF-36)
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
Measured: Up to twelve weeks
The Yesavage Geriatric Depression Scale
Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
Measured: Up to twelve weeks
Anxiety
Anxiety was assessed using the Hamilton Scale [25], an instrument designed to identify and measure anxiety symptoms, exploring the alteration of the emotional state, as well as subjective sensations of tension, restlessness or nervousness. The scale consists of 14 items covering physical, mental and behavioural symptoms related to anxiety. Of these items, 7 are aimed at assessing psychological anxiety (items 1-6 and 14), while the other 7 focus on somatic anxiety (items 7-13). Each item is scored on a scale ranging from 0 to 4, where: 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very severe. The total score of the scale ranges from 0 to 56 points, with higher values reflecting a greater intensity of anxiety symptoms.
Measured: Up to twelve weeks
Perceived Stress
The Perceived Stress Scale (PSS) is a self-administered questionnaire designed to measure the level of perceived stress over the past month [28,29]. This instrument consists of 14 items that are answered using a five-point scale (0 = never, 1 = almost never, 2 = sometimes, 3 = often, 4 = very often). To calculate the total score, the responses to items 4, 5, 6, 7, 9, 10, and 13 are reversed (assigning values of 0=4, 1=3, 2=2, 3=1, and 4=0) and then the scores for all items are summed. The total range varies between 0 and 56 points, with higher scores indicating a higher level of perceived stress.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start5 Nov 2024
- Primary completion23 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671574
- Sponsor's protocol ID
- ^University of Jaén^
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Intelligence and Relaxation Techniques in Mental Health, Sleep Disorders, and Quality of Life in Adults Over 60 Years
- ClinicalTrials.gov ID
- NCT06671574
- Acronym / sponsor ID
- ^University of Jaén^
- Conditions
- Older People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This topic highlights the role of emotional intelligence and relaxation techniques in enhancing mental health for adults over 60. Emotional intelligence, which involves understanding and managing one's emotions, can improve emotional well-being in older adults facing challenges like loneliness and anxiety. Sleep disorders are common in this age group and can lead to increased mental health issues such as depression. Relaxation techniques, including meditation, yoga, and deep breathing, have been shown to reduce stress and improve sleep quality. By integrating emotional intelligence and relaxation practices into daily life, older adults can enhance their overall quality of life and mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will not receive intervention, but will receive information sessions on general health and well-being topics, such as sleep hygiene, healthy lifestyle habits and practical tips to improve rest, in order to control for the placebo effect. These information sessions will be held at the beginning of the study and will be supported by brochures and educational material. |
| Experimental Group | Experimental | Other: Emotional intelligence and Relaxation techniquesThis group will participate in a structured program that combines the development of emotional intelligence with relaxation techniques. It will last 12 weeks, with sessions twice a week, each lasting approximately 60 minutes. The sessions will be led by a mental health professional. During the sessions, exercises will be worked on to recognize, understand and regulate emotions, allowing participants to develop skills to better manage stress and anxiety. In addition, relaxation techniques such as deep breathing, guided meditation and visualization will be practiced, which have been shown to be effective in reducing muscle tension, lowering cortisol levels and promoting restful sleep. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People aged 60 years or older.
- Older adults with mental health problems, such as anxiety, stress, or mild depressive symptoms.
- Participants who report difficulty falling or staying asleep, or who have some type of sleep disorder (such as insomnia or fragmented sleep).
- People willing to participate in emotional intelligence interventions and relaxation techniques.
- Older adults who live in a stable environment (private housing, community centers, etc.) and who have sufficient cognitive abilities to understand and follow basic instructions for relaxation techniques.
Key exclusion criteria (5 listed)
- People under 60 years of age.
- Older adults with serious psychiatric disorders, such as advanced dementia, schizophrenia, or uncontrolled bipolar disorder, that could interfere with effective participation in the interventions.
- Participants with serious physical health problems, such as unstable heart disease or advanced respiratory failure, that could be worsened by relaxation techniques or limit their participation.
- People who are already receiving specific treatment for sleep disorders that includes medication or intensive psychotherapeutic interventions, since these could interfere with the results of the study.
- Older adults with severe sensory limitations (such as deafness or uncorrected blindness) that prevent them from understanding or adequately performing the proposed relaxation techniques.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional intelligence and Relaxation techniquesIn each session, participants will engage in exercises aimed at recognizing, understanding, and regulating their emotions. These interactive activities will foster personal reflection and group discussion, helping individuals identify emotions in various situations and their impact on behavior. This approach will enhance emotional awareness and equip participants with practical tools for managing stress and anxiety. Various relaxation techniques will also be introduced. Deep breathing exercises will teach participants to calm their minds and bodies, reducing tension. Guided meditation will help them focus inward, promoting mental peace and deep relaxation. Additionally, visualization exercises will encourage imagining calming scenarios, alleviating anxiety and improving overall well-being. | Other | Experimental Group |
Primary outcome
The Short Form-36 Health Survey (SF-36)
Time frame: Up to twelve weeks
Used extensively for assessing health-related quality of life. The results are values between 0 and 100. Optimal health is represented by scores of 100 and very poor health would equal 0.
The Yesavage Geriatric Depression Scale
Time frame: Up to twelve weeks
Questionnaire used to screen for depression in older people. Scores from 00 to 05 indicate Normal screening, 06 to 10 Moderate Depression screening, and 11 to 15 Severe Depression screening.
Anxiety
Time frame: Up to twelve weeks
Anxiety was assessed using the Hamilton Scale [25], an instrument designed to identify and measure anxiety symptoms, exploring the alteration of the emotional state, as well as subjective sensations of tension, restlessness or nervousness. The scale consists of 14 items covering physical, mental and behavioural symptoms related to anxiety. Of these items, 7 are aimed at assessing psychological anxiety (items 1-6 and 14), while the other 7 focus on somatic anxiety (items 7-13). Each item is scored on a scale ranging from 0 to 4, where: 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe and 4 = Very severe. The total score of the scale ranges from 0 to 56 points, with higher values reflecting a greater intensity of anxiety symptoms.
Perceived Stress
Time frame: Up to twelve weeks
The Perceived Stress Scale (PSS) is a self-administered questionnaire designed to measure the level of perceived stress over the past month [28,29]. This instrument consists of 14 items that are answered using a five-point scale (0 = never, 1 = almost never, 2 = sometimes, 3 = often, 4 = very often). To calculate the total score, the responses to items 4, 5, 6, 7, 9, 10, and 13 are reversed (assigning values of 0=4, 1=3, 2=2, 3=1, and 4=0) and then the scores for all items are summed. The total range varies between 0 and 56 points, with higher scores indicating a higher level of perceived stress.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional intelligence and Relaxation techniques in people with Older People, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Short Form-36 Health Survey (SF-36) (time frame: Up to twelve weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.