Stress, PsychologicalNCT06557486
The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities
A study testing Mindfulness-Based Stress reduction in people with Stress, Psychological and Stress, Emotional, run by Universitat de Lleida at 1 site in Spain.
Trial summary
The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological, Stress, Emotional, Stress
- What is being tested?
- Mindfulness-Based Stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2025to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not having attended previously a mindfulness course
- A score equal to or greater than 23 points at the PSS.
- >18 years old
- Children <18y with motor/physical disability due to a Neurological disorder.
- Spanish/Catalan speaking
Who cannot join
- Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
- Regular meditation practice (once a week in the past 12 months)
- Diagnose of hypertension stage 2
- Pregnancy in the case of mothers
- Present hyperthyroidism
- Primary adrenal insufficiency syndromes such as Cushing syndrome or Addison disease
- Present any kind of infection or inflammation process, different from the interestingly to the present study that could differ the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mindfulness-Based Stress Reduction Program on the Psychological and Physiological Stress of Family or Caregivers of Children With Motor Disabilities Due to a Neurological Disorder: A Randomized Controlled Trial
The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.
- Conditions
- Stress, Psychological, Stress, Emotional, Stress
- Being tested
- Mindfulness-Based Stress reduction
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress reductionBehavioural
Participants assigned to the 8-week mindfulness program attended weekly 120-150 minute in-person group sessions for the entire duration. In these sessions, the instructor progressively will introduce and guide formal mindfulness practices while facilitating the sharing of experiences.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress reduction arm | Experimental | Not described Receives: Behavioral: Mindfulness-Based Stress reduction |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
To measure participants perceived stress, the Perceived Stress Scale 14 item Spanish version will be used (PSS 14). It consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress).
Measured: baseline, two months (through study completion), and follow-up of one month
Cortisol levels
The cortisol measurement will be sampled with a serum blood test. It is recommended to advise the participants to be fasted. 63 Cortisol levels fluctuate throughout the day, being highest in the morning and lowest at night.63,64 The sample will be collected between 8-9 am to get the highest cortisol.
Measured: baseline and two months (through study completion)
Secondary outcomes (7)
Severity of clinic anxiety
To measure the severity of clinic anxiety, the Bech Anxiety Inventory will be used. It consists of 21 self-administered questions about how the individual has been feeling the last week, expressed in common anxiety symptoms. It takes up to 5-10 minutes. Scores 0-7 indicate minimal anxiety, 8-15 mild anxiety, 16-25 moderate anxiety and 26-63 severe anxiety. Each item on the BAI includes an anxiety symptom and for each of them, the participant must assess the degree to which they have been affected by it during the last week. Possible answers are: not at all, mildly but it didn't bother me much, moderately it wasn't pleasant at times, severely it bothered me a lot. (0 to 3 respectively).
Measured: baseline, two months (through study completion), and follow-up of one month
Sleep Quality
To measure sleep quality, the Pittsburgh Sleep Quality Index (PSQI) will be assessed. It is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The instrument should require between 5 and 10 min for completion. The questionnaire consists of a combination of Likert-type and open-ended questions (later converted to scaled scores using provided guidelines). Respondents are asked to indicate how frequently they have experienced certain sleep difficulties over the past month and to rate their overall sleep quality. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances. Developers have suggested a cutoff score of 5 for the global scale. The seven component scores are then combined to produce a global PSQI score, which ranges from 0 to 21; higher scores reflect poorer sleep quality
Measured: baseline, two months (through study completion), and follow-up of one month
Quality of Life assessment
To measure the impact of paediatric chronic health conditions on parents and the family, the last developed PedsQL™ Family Impact Module will be used. The module measures multidimensions parent self-report; physical, emotional, social, and cognitive functioning, communication, and worry. It is used to assess health-related QoL in children aged 2-18 years. It takes up to 5-10 minutes to be completed.It assesses 8 main factors: physical functioning (6 items), emotional functioning (5 items), social functioning (4 items), cognitive functioning (4 items), communication (3 items), worry (5 items), daily activities (3 items) and family relationships (5 items). The answers are given on a 5-point Likert scale (0 = it is never a problem, 4 = it is almost always a problem) and are reversed scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) so that a greater score indicates better functioning
Measured: baseline, two months (through study completion), and follow-up of one month
Blood pressure
BP will be measured, after 5 min of rest, three times at intervals of 1 minute using a sphygmomanometer. The clinical BP values used in the analysis will be the averages for the three measurements. BP measurements will be done pre-intervention, post-intervention and with a follow-up of one mont. both systolic and diastolic measures.
Measured: baseline, two months (through study completion), and follow-up of one month
Resting Heart rate
HR will be measured, after 5 min of rest, three times at intervals of 1 minute using a pulsometer on the index finger. The clinical HR values used in the analysis will be the averages for the three measurements.
Measured: baseline, two months (through study completion), and follow-up of one month
Respiratory rate
Respiratory rate will be measured after 5 min of rest, three times at intervals of 1 minute using the same sphygmomanometer of the BP. The clinical RR values used in the analysis will be the averages for the three measurements. RR measurements will be done pre-intervention, post-intervention and with a follow-up of one month.
Measured: baseline, two months (through study completion), and follow-up of one month
Interleukin 6 (IL-6)
The same procedure will be taken for the IL-6 .65 Under homeostatic conditions, IL-6 levels in the circulation are as low as 1-5 pg/ml, but during inflammatory states, these levels can rise more than 1,000-fold
Measured: baseline and two months (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startJan 2025 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clàudia Arumí, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557486
- Sponsor's protocol ID
- ULleida2
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness-Based Stress Reduction Program on the Psychological and Physiological Stress of Family or Caregivers of Children With Motor Disabilities Due to a Neurological Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06557486
- Acronym / sponsor ID
- ULleida2
- Conditions
- Stress, Psychological, Stress, Emotional, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Aug 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.
The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress reduction arm | Experimental | Behavioral: Mindfulness-Based Stress reduction |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Not having attended previously a mindfulness course
- A score equal to or greater than 23 points at the PSS.
- >18 years old
- Children <18y with motor/physical disability due to a Neurological disorder.
- Spanish/Catalan speaking
Key exclusion criteria (7 listed)
- Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
- Regular meditation practice (once a week in the past 12 months)
- Diagnose of hypertension stage 2
- Pregnancy in the case of mothers
- Present hyperthyroidism
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 |
|---|---|---|
| Mindfulness-Based Stress reductionParticipants assigned to the 8-week mindfulness program attended weekly 120-150 minute in-person group sessions for the entire duration. In these sessions, the instructor progressively will introduce and guide formal mindfulness practices while facilitating the sharing of experiences. | Behavioural | Mindfulness-Based Stress reduction arm |
Primary outcome
Perceived Stress
Time frame: baseline, two months (through study completion), and follow-up of one month
To measure participants perceived stress, the Perceived Stress Scale 14 item Spanish version will be used (PSS 14). It consists of 14 items scored from 0 up to 4 (0=never, 1 = rarely 2= sometimes 3= usually 4 =almost always). The total scores on the scale can range from 0 (no stress) to 56 (extreme stress).
Cortisol levels
Time frame: baseline and two months (through study completion)
The cortisol measurement will be sampled with a serum blood test. It is recommended to advise the participants to be fasted. 63 Cortisol levels fluctuate throughout the day, being highest in the morning and lowest at night.63,64 The sample will be collected between 8-9 am to get the highest cortisol.
7 secondary outcomes
Severity of clinic anxiety
Time frame: baseline, two months (through study completion), and follow-up of one month
Sleep Quality
Time frame: baseline, two months (through study completion), and follow-up of one month
Quality of Life assessment
Time frame: baseline, two months (through study completion), and follow-up of one month
Blood pressure
Time frame: baseline, two months (through study completion), and follow-up of one month
Resting Heart rate
Time frame: baseline, two months (through study completion), and follow-up of one month
Respiratory rate
Time frame: baseline, two months (through study completion), and follow-up of one month
Interleukin 6 (IL-6)
Time frame: baseline and two months (through study completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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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 Mindfulness-Based Stress reduction in people with Stress, Psychological and Stress, Emotional, run by Universitat de Lleida 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 7 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 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?
Results are not available in the source record.
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?
Perceived Stress (time frame: baseline, two months (through study completion), and follow-up of one month). The study lists 2 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 16 Aug 2024.