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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Did not have depression, according to the Geriatric Depression Scale Short Form (GDS SF), which has a 0 to 4 score range.
- 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.
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).
- Conditions
- Emotional Regulation, Peace of Mind, Older Adults
- 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 group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | senior 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 group | No intervention | the 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.
Mini-Mental State Examination Scale (MMES)
Measured: 3 month
Secondary outcomes (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.
- First posted27 Jun 2023
- Study start22 Jan 2023
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha salah elsayed eweida, Alexandria University
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Constructive Emotional Management Interventions on Emotional Regulation Difficulties and Peace of Mind Among Older Adults: Current Gap and Future Orientation
- ClinicalTrials.gov ID
- NCT05920057
- Acronym / sponsor ID
- 1512023
- Conditions
- Emotional Regulation, Peace of Mind, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 27 Jun 2023 (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.
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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Behavioral: constructive emotional management interventionssenior 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 |
| control group | No intervention | –the control group, which received the elderly clubs' regular services |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| constructive emotional management interventionsThe 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. | Behavioural | interventional group |
Primary outcome
Mini-Mental State Examination Scale (MMES)
Time frame: 3 month
1 secondary outcome
II) Geriatric Depression Scale- Short Form (GDS-SF)
Time frame: 3 month
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 27 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
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.