NCT06671574

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2025

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

October 31, 2024

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Up to twelve weeks

Study Arms (2)

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.

Other: Emotional intelligence and Relaxation techniques

Interventions

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.

Experimental Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paola Romera Gasparico

Jaén, 23002, Spain

Location

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 4, 2024

Study Start

November 5, 2024

Primary Completion

January 23, 2025

Study Completion

January 28, 2025

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations