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Emotional RegulationNCT05920057

Constructive Emotional Management Interventions

A study testing constructive emotional management interventions in people with Emotional Regulation and Peace of Mind, run by Alexandria University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Emotional dysregulation is considered a phenotypic finding that has a purported impact on older adults' peace of mind. In this venue, employing constructive emotional management intervention is one of the breakthroughs that has been empirically targeted to restore positive emotional states and strengthen mental… Read more about this study

Who is it for?
Ages 60 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Emotional Regulation, Peace of Mind, Older Adults
What is being tested?
constructive emotional management interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesEgypt
Study dates
22 Jan 2023to 30 Mar 2023
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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Inclusion Criteria:1. The ability to write and read. 2. Had a Mini Mental State Examination Scale (MMES) score of 24 or higher, indicating normal cognitive function.

  1. Did not have depression, according to the Geriatric Depression Scale Short Form (GDS SF), which has a 0 to 4 score range.
  2. Difficulties with emotional regulation: a score of 17 or higher on the Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16.

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Exclusion Criteria: those who have cognitive impairment such as dementia

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Trial locations and contacts

2 sites in 1 country.

Egypt2 sites
  • Faculty of Nursing

    Alexandria, 21523

  • Faculty of Nursing

    Alexandria

Other trials in Egypt

About this study

Official title: Effect of Constructive Emotional Management Interventions on Emotional Regulation Difficulties and Peace of Mind Among Older Adults: Current Gap and Future Orientation

Emotional dysregulation is considered a phenotypic finding that has a purported impact on older adults' peace of mind. In this venue, employing constructive emotional management intervention is one of the breakthroughs that has been empirically targeted to restore positive emotional states and strengthen mental clarity in the geriatric population. Aim: to determine the effect of constructive emotional management interventions on emotional regulation difficulties and peace of mind among older adults. Design: The present study adopted a quasi-experimental methodological approach.

Read the detailed description

Most elderly people are emotionally stable and well-regulated up until the age of 70 to 80. Due to the effects of changes in their personal circumstances, some older people, however, regard their mental and physical deterioration as becoming self-evident before they turn 70. In old age, it's normal to experience things like forced retirement, the death of a spouse, changes in the home, or financial insecurity. In old age, a great variety of emotions are felt (Kunzmann et al., 2022).

Emotion is a psychological and cultural adaptation process that enables each person to respond adaptably and dynamically to environmental changes. Emotions add meaning to life, deepen human connections, teach people about their needs and feelings, and inspire them to take action (Troy et al., 2018). The phenomenon of emotions is complex. A single emotion consists of a cognitive evaluation, a bodily sensation, an intention, a personal sentiment, a motor response, and, frequently, an interpersonal component (Rompilla et al., 2022). Everyone, especially older adults, experience emotions on a regular basis. They face a wide range of emotions throughout any given day, along with their highs and lows. While some of these are manageable, others are more intense and challenging. It's common to experience those emotions occasionally. Yet, if they struggle with emotion management for an extended length of time, it may result in mental health issues and emotional regulation difficulties (McRae \& Gross 2020).

A response to emotions that is poorly controlled and does not fall within the parameters of an acceptable emotional reaction is referred to as having problems with emotional regulation. The terms marked mood fluctuation, mood swings, and labile mood are also used to describe emotional regulation difficulties. Anger outbursts, anxiety, sadness, substance misuse, suicidal ideation, self-harm, and other self-destructive behaviors may be displayed by older adults who have trouble controlling their emotions. Negative moods, personality disorders, psychosis, and post- traumatic stress disorder are all strongly predicted by problems with emotional regulation. Over time, this disorder may affect older persons' quality of life, social contacts, and personal relationships (Dunn et al., 2018).

One's life balance can be thrown off by negative emotions, which are harmful. Lower mental health and inner peace are associated with higher levels of internal conflict, violence, and negative feelings and ideas. In fact, negative emotions and thoughts play a significant influence in the peace of mind maladjustment. In later life, especially, there may be a considerable correlation between peace of mind and effective emotion control. The spiritual and wisdom frequently represent a sense of inner harmony and a sense of wholeness and integration of the mind and body. The more inner peace elderly people have, the better off their minds are. As a result, regulating emotions may be a key therapy goal in psychological interventions for older persons (Isaacowitz 2022).

A reduction in the ability to control older adults' emotions might happen suddenly, but it can also happen gradually, slowly, and subtly. Hence, gerontological nurses should evaluate and identify any potential mental and emotional distress related to this crucial transitional aging era. Anxiety, despair, worry, and fear are frequently present throughout this time. Also, gerontological nurses should intervene to teach elders how to effectively control and manage their emotions and build personalized plans for each elder. Also, they should take action to stop older persons from making self- destructive decisions and engaging in behaviors like loneliness, sadness, suicide, denial of treatment, and denial of care from family members or medical professionals (Erhan et al.,2021).

Older persons who participate in educational emotional management nursing programs may experience an increase in positive emotions and a decrease in negative ones. The recommended therapies for the current study, constructive emotional management interventions, were constructed on the Dialectical Behavioral Therapy model (DBT). Linehan (2015) developed DBT, a cognitive behavioral treatment that incorporates evidence-based psychotherapy. Borderline personality disorder was its original intended application (BPD). Nowadays, it is utilized to treat a variety of emotional dysregulation and impulse control disorders and symptoms (Linehan \& Wilks 2015).

Constructive emotional management therapies, which are based on DBT, are made up of a variety of skills that assist older persons in controlling their emotions, fostering better relationships, and enduring difficult circumstances without impulsivity. These interventions involve skills that should be incorporated and practiced into the daily lives of older individuals. They function similarly to muscles strengthen with use over

time. They instruct elderly people on what best skills are needed, when, and how to implement them. Thus further, constructive emotional management interventions could increase mental clarity, restore emotional dimensions, improve coping mechanisms, and lessen depressive symptoms as people age. The prevention or treatment of mental health issues as well as enhancing mental well-being and peace of mind in old age appear to be potential outcomes of constructive emotional management interventions with an emphasis on emotion-regulation. (Delhom et al., 2018).

Being tested
constructive emotional management interventions
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • constructive emotional management interventionsBehavioural

    The Constructive emotional management interventions sessions were conducted in the activity rooms of the elderly clubs where the researchers met the participants. Participants completed a baseline evaluation of the outcome measures of the researched variables after being found to be eligible for the current study and indicating their willingness to participate willingly. After explaining the study's objectives to participants, the researchers themselves delivered the Constructive Emotional Management Interventions program, which had been vetted by experts in the field.

Study groups in NCT05920057
Study groupRoleWhat they receive
interventional groupExperimentalsenior citizens aged 60 and more were randomly assigned into two equal groups at and placed in the study group, which received the constructive emotional management interventions
Receives: Behavioral: constructive emotional management interventions
control groupNo interventionthe control group, which received the elderly clubs' regular services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mini-Mental State Examination Scale (MMES)

    Measured: 3 month

Secondary outcomes (1)
  1. II) Geriatric Depression Scale- Short Form (GDS-SF)

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start22 Jan 2023
  3. Primary completion28 Feb 2023
  4. Study completion30 Mar 2023

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05920057
Sponsor's protocol ID
1512023
Status last verified
Jun 2023
First submitted
16 Jun 2023
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing constructive emotional management interventions in people with Emotional Regulation and Peace of Mind, run by Alexandria University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. 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?

Mini-Mental State Examination Scale (MMES) (time frame: 3 month). 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 27 Jun 2023.

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