Posttraumatic Stress Disorder (PTSD)ResilienceNCT06746818
Resilience Building Among Older Adults: the Heart Math Based Interventions for Posttraumatic Stress Disorder, Spirituality and Psychosocial Well-being
A study testing Heart Math interventions in people with Posttraumatic Stress Disorder (PTSD), run by Mansoura University at 1 site in Egypt.
Trial summary
Resilience building among older adults: The Heart Math based interventions for posttraumatic stress disorder, spirituality and psychosocial well-being. Resilience building among older adults is critically important, especially in the context of mental health challenges such as posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Heart Math interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Older adults aged 60 or more for both the control and study groups.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Resilience building among older adults: The Heart Math based interventions for posttraumatic stress disorder, spirituality and psychosocial well-being.
Resilience building among older adults is critically important, especially in the context of mental health challenges such as posttraumatic stress disorder (PTSD). Interventions that promote well-being through innovative methods can significantly enhance the quality of life in this demographic. One such approach is the Heart Math-based intervention, which integrates techniques for emotional regulation, stress reduction, and overall psychosocial well-being.
Read more
Understanding Heart Math Interventions The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of older adults with PTSD, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.
. The key components of Heart Math interventions include:
- Heart Rate Variability (HRV) Training: This involves biofeedback techniques to help individuals learn how to control their heart rate and promote emotional balance.
- Quick Coherence Technique: Participants are guided through a series of steps to shift their emotional state from stress to calmness, facilitating a sense of peace and emotional clarity.
- Focus on Positive Emotions: Encouraging individuals to cultivate feelings like gratitude and compassion can enhance resilience and overall mental well-being.
- Mindfulness Practices: Incorporating mindfulness helps individuals become more aware of their thoughts and feelings, allowing them to respond to stressors more effectively.
Impact on PTSD and Psychosocial Well-Being
For older adults experiencing PTSD, Heart Math interventions can offer several benefits:
- Reduced Anxiety and Stress: By learning techniques to control physiological responses to stress, older adults can experience lower levels of anxiety and an improved ability to manage PTSD symptoms.
- Enhanced Emotional Regulation: These interventions help individuals to better regulate their emotions, reducing instances of emotional dysregulation often seen in PTSD.
- Greater Spiritual Connection: Engaging in practices that promote positive emotions and mindfulness can enhance a sense of spirituality and purpose, which is particularly beneficial in aging populations.
- Improved Social Support: Group-based Heart Math interventions can foster social connections, which play a key role in building resilience among older adults.
- Overall Well-Being: Focusing on emotional health fosters a holistic outlook, improving physical, mental, and spiritual well-being.
Practical Implementation
- Workshops and Group Sessions: Facilitate group workshops that incorporate Heart Math techniques. This encourages peer support and sharing of experiences.
- Personal Coaching: Offer one-on-one sessions to guide older adults through Heart Math practices, tailored to their specific needs and trauma experiences.
- Follow-Up and Support: Establish ongoing support systems, such as regular check-ins or additional resources, to help maintain the benefits gained through the interventions.
- Integrate into Existing Programs: Consider incorporating these techniques into existing mental health programs targeting older adults, enhancing current offerings with a focus on resilience. summary Heart Math-based interventions present a promising approach to resilience building among older adults, particularly those dealing with PTSD. By addressing emotional regulation, enhancing spiritual well-being, and fostering psychosocial support, these interventions can lead to significant improvements in quality of life and mental health outcomes. As the population of older adults continues to grow, such innovative approaches will be essential in supporting their mental health and emotional resilience.
Research hypothesis: Older adults with PTSD who participate in HeartMath training program will show a statistically significant increase in resilience, spiritualty, and psychosocial wellbeing compared to those who do not participate in the program Setting: Elderly homes, Damanhour city, Elbehaira Governorate, Egypt. Subject: 120 older adults with PTSD. Tools: The posttraumatic Diagnostic scale, The Connor Davidson Resilience scale-10, Spiritual wellbeing scale, and psychosocial wellbeing questionnaire.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Heart Math interventions
- Keywords
- Resilience, older adults, posttraumatic stress disorder, spirituality, psychosocial well-being
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Math interventionsBehavioural
. The key components of Heart Math interventions include:
- Heart Rate Variability (HRV) Training: This involves biofeedback techniques to help individuals learn how to control their heart rate and promote emotional balance.
- Quick Coherence Technique: Participants are guided through a series of steps to shift their emotional state from stress to calmness, facilitating a sense of peace and emotional clarity.
- Focus on Positive Emotions: Encouraging individuals to cultivate feelings like gratitude and compassion can enhance resilience and overall mental well-being.
- Mindfulness Practices: Incorporating mindfulness helps individuals become more aware of their thoughts and feelings, allowing them to respond to stressors more effectively.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | No care |
| Intervention | Experimental | . The key components of Heart Math interventions include:
1. Heart Rate Variability (HRV) Training: This involves biofeedback techniques to help individuals learn how to control their heart rate and promote emotional balance.
2. Quick Coherence Technique: Participants are guided through a series of steps to shift their emotional state from stress to calmness, facilitating a sense of peace and emotional clarity.
3. Focus on Positive Emotions: Encouraging individuals to cultivate feelings like gratitude and compassion can enhance resilience and overall mental well-being.
4. Mindfulness Practices: Incorporating mindfulness helps individuals become more aware of their thoughts and feelings, allowing them to respond to stressors more effectively. Receives: Behavioral: Heart Math interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tool II: The Posttraumatic Diagnostic Scale (The PDS-5)
Primary Outcome Measure: The PDS-5 is a self-report instrument that involves 24 elements and evaluates PTSD symptom severity in the past month in accordance with DSM-5 criteria (Foa et al., 2016). The PDS-5 begins with trauma-history screen questions to assess the trauma history of the participant. Twenty questions were devised to assess the presence and severity of the PTSD symptoms in relation to the index trauma; symptom questions were based on the DSM-5 symptom clusters of intrusion (Items 1-5), avoidance (Items 6 -7), changes in mood and cognition (Items 8 -14), and arousal and hyper-reactivity (Items 15-20).
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Tool III: The Connor-Davidson Resilience Scale-10-Item
The original Connor-Davidson Resilience Scale 10 (CDRISC 10) was developed by Campbell-Sills \& Stein (2007) that was prepared based on the CD-RISC 25 (Connor \& Davidson, 2003) comprises 10 self-report items, each rated on a Likert-type scale from 0 (not true at all) to 4 (true nearly all the time). In its original version, all of the 10 items load on a single dimension. The respondents complete the scale based on the degree to which they admit each item on the scale was applicable to them in the preceding 1 month. The total score could range from 0 to 40 with higher scores indicating greater resilience of the respondent.
Measured: through study completion, an average of 1 year
Tool IV: Spiritual Well-being Scale
This scale was developed by Ellison (1983). It was widely used and well validated scale (Ellison \& Smith, 1991). It is designed to assess religious and existential well-being. It was translated into Arabic language by Musa \& Pevalin (2012) and proved to be valid. The scale comprises 20 statements. It is consisting of two subscales of 10 items each. The Religious Well-Being (RWB) subscale assesses the degree to which individuals report that they experience a satisfying relationship with God. Items of the Existential Well-Being (EWB) subscale relate to a sense of life satisfaction and purpose. Negatively worded items are reverse scored. Even numbered items assess existential well-being and odd numbered items assess religious well-being. The responses are rated on a 6-point Likert scale ranging from (1) indicating "strongly disagree" to (6) indicating "strongly agree".
Measured: through study completion, an average of 1 year
Tool V: Psychosocial Wellbeing Questionnaire
It was developed by HalimahAwang et al., (2021) , which composed of 17 statements, eight positive and nine negative related to the outlook on life as experienced by the respondents in the past six months. It covering the domains of psychosocial wellbeing which include loneliness, life satisfaction and happiness. Each statement was measured on a five-point Likert scale where 1=never, 2=rarely, 3=sometimes, 4=often and 5=always.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jul 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Heart Math Institute has been researching the relationship between the heart, brain, and body and its association to personal well-being and optimal functioning. Based on extensive research, the institute has developed a program that teaches participants the science behind and techniques designed to reduce the negative effects of stress and increase resilience (HeartMath Institute, 2020). The HeartMath intervention was conducted after the researcher successfully completed 13 hours (over two months) training of professional development in "The Resilience Heart TM: Trauma- Sensitive HeartMath Course" from HeartMath Institute.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hashem El-Monshed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746818
- Sponsor's protocol ID
- EHEART
- Acronym
- Resilience
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Building Among Older Adults: the Heart Math Based Interventions for Posttraumatic Stress Disorder, Spirituality and Psychosocial Well-being
- ClinicalTrials.gov ID
- NCT06746818
- Acronym / sponsor ID
- Resilience / EHEART
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Resilience, older adults, posttraumatic stress disorder, spirituality, psychosocial well-being
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 24 Dec 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.
Resilience building among older adults: The Heart Math based interventions for posttraumatic stress disorder, spirituality and psychosocial well-being.
Resilience building among older adults is critically important, especially in the context of mental health challenges such as posttraumatic stress disorder (PTSD). Interventions that promote well-being through innovative methods can significantly enhance the quality of life in this demographic. One such approach is the Heart Math-based intervention, which integrates techniques for emotional regulation, stress reduction, and overall psychosocial well-being.
Understanding Heart Math Interventions The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of older adults with PTSD, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.
. The key components of Heart Math interventions include:
- Heart Rate Variability (HRV) Training: This involves biofeedback techniques to help individuals learn how to control their heart rate and promote emotional balance.
- Quick Coherence Technique: Participants are guided through a series of steps to shift their emotional state from stress to calmness, facilitating a sense of peace and emotional clarity.
- Focus on Positive Emotions: Encouraging individuals to cultivate feelings like gratitude and compassion can enhance resilience and overall mental well-being.
- Mindfulness Practices: Incorporating mindfulness helps individuals become more aware of their thoughts and feelings, allowing them to respond to stressors more effectively.
Impact on PTSD and Psychosocial Well-Being
For older adults experiencing PTSD, Heart Math interventions can offer several benefits:
- Reduced Anxiety and Stress: By learning techniques to control physiological responses to stress, older adults can experience lower levels of anxiety and an improved ability to manage PTSD symptoms.
- Enhanced Emotional Regulation: These interventions help individuals to better regulate their emotions, reducing instances of emotional dysregulation often seen in PTSD.
- Greater Spiritual Connection: Engaging in practices that promote positive emotions and mindfulness can enhance a sense of spirituality and purpose, which is particularly beneficial in aging populations.
- Improved Social Support: Group-based Heart Math interventions can foster social connections, which play a key role in building resilience among older adults.
- Overall Well-Being: Focusing on emotional health fosters a holistic outlook, improving physical, mental, and spiritual well-being.
Practical Implementation
- Workshops and Group Sessions: Facilitate group workshops that incorporate Heart Math techniques. This encourages peer support and sharing of experiences.
- Personal Coaching: Offer one-on-one sessions to guide older adults through Heart Math practices, tailored to their specific needs and trauma experiences.
- Follow-Up and Support: Establish ongoing support systems, such as regular check-ins or additional resources, to help maintain the benefits gained through the interventions.
- Integrate into Existing Programs: Consider incorporating these techniques into existing mental health programs targeting older adults, enhancing current offerings with a focus on resilience. summary Heart Math-based interventions present a promising approach to resilience building among older adults, particularly those dealing with PTSD. By addressing emotional regulation, enhancing spiritual well-being, and fostering psychosocial support, these interventions can lead to significant improvements in quality of life and mental health outcomes. As the population of older adults continues to grow, such innovative approaches will be essential in supporting their mental health and emotional resilience.
Research hypothesis: Older adults with PTSD who participate in HeartMath training program will show a statistically significant increase in resilience, spiritualty, and psychosocial wellbeing compared to those who do not participate in the program Setting: Elderly homes, Damanhour city, Elbehaira Governorate, Egypt. Subject: 120 older adults with PTSD. Tools: The posttraumatic Diagnostic scale, The Connor Davidson Resilience scale-10, Spiritual wellbeing scale, and psychosocial wellbeing questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The Heart Math Institute has been researching the relationship between the heart, brain, and body and its association to personal well-being and optimal functioning. Based on extensive research, the institute has developed a program that teaches participants the science behind and techniques designed to reduce the negative effects of stress and increase resilience (HeartMath Institute, 2020). The HeartMath intervention was conducted after the researcher successfully completed 13 hours (over two months) training of professional development in "The Resilience Heart TM: Trauma- Sensitive HeartMath Course" from HeartMath Institute.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –No care |
| Intervention | Experimental | Behavioral: Heart Math interventions. The key components of Heart Math interventions include: 1. Heart Rate Variability (HRV) Training: This involves biofeedback techniques to help individuals learn how to control their heart rate and promote emotional balance. 2. Quick Coherence Technique: Participants are guided through a series of steps to shift their emotional state from stress to calmness, facilitating a sense of peace and emotional clarity. 3. Focus on Positive Emotions: Encouraging individuals to cultivate feelings like gratitude and compassion can enhance resilience and overall mental well-being. 4. Mindfulness Practices: Incorporating mindfulness helps individuals become more aware of their thoughts and feelings, allowing them to respond to stressors more effectively. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older adults aged 60 or more for both the control and study groups.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Heart Math interventions. The key components of Heart Math interventions include: 1. Heart Rate Variability (HRV) Training: This involves biofeedback techniques to help individuals learn how to control their heart rate and promote emotional balance. 2. Quick Coherence Technique: Participants are guided through a series of steps to shift their emotional state from stress to calmness, facilitating a sense of peace and emotional clarity. 3. Focus on Positive Emotions: Encouraging individuals to cultivate feelings like gratitude and compassion can enhance resilience and overall mental well-being. 4. Mindfulness Practices: Incorporating mindfulness helps individuals become more aware of their thoughts and feelings, allowing them to respond to stressors more effectively. | Behavioural | Intervention |
Primary outcome
Tool II: The Posttraumatic Diagnostic Scale (The PDS-5)
Time frame: through study completion, an average of 1 year
Primary Outcome Measure: The PDS-5 is a self-report instrument that involves 24 elements and evaluates PTSD symptom severity in the past month in accordance with DSM-5 criteria (Foa et al., 2016). The PDS-5 begins with trauma-history screen questions to assess the trauma history of the participant. Twenty questions were devised to assess the presence and severity of the PTSD symptoms in relation to the index trauma; symptom questions were based on the DSM-5 symptom clusters of intrusion (Items 1-5), avoidance (Items 6 -7), changes in mood and cognition (Items 8 -14), and arousal and hyper-reactivity (Items 15-20).
3 secondary outcomes
Tool III: The Connor-Davidson Resilience Scale-10-Item
Time frame: through study completion, an average of 1 year
Tool IV: Spiritual Well-being Scale
Time frame: through study completion, an average of 1 year
Tool V: Psychosocial Wellbeing Questionnaire
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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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.
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 Heart Math interventions in people with Posttraumatic Stress Disorder (PTSD), run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 Dec 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Tool II: The Posttraumatic Diagnostic Scale (The PDS-5) (time frame: through study completion, an average of 1 year). 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 24 Dec 2024.