Parental BurnoutNCT05620368
Mindfulness for Mothers of Children With Disabilities
A study testing Mindfulness and Compassionate Living Course (MCLC) in people with Parental Burnout and Caregiver Burnout, run by Wroclaw University of Health and Sport Sciences at 3 sites in Poland.
Trial summary
The main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parental Burnout, Caregiver Burnout
- What is being tested?
- Mindfulness and Compassionate Living Course (MCLC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesPoland
- Study dates
- 1 Oct 2021to 28 Feb 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- mother of childern with disabilities
Who cannot join
- substance abuse;
- participation in another therapeutic project or individual psychotherapy;
- antidepressant treatment.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Jan Dlugosz University in Czestochowa
Częstochowa, Upper Silesia, 42-200
University of Silesia in Katowice
Katowice, Upper Silesi, 40-007
Wroclaw University of Health and Sport Sciences
Wroclaw, Lower Silesian Voivodeship, 51-612
About this study
Official title: Mindfulness-Based Online Support Program for Mothers of Children With Disabilities
The main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities.
Read the detailed description
Parenthood is accompanied by significant mental and physical effort accompanied by different sources of long-term stress and encumbrance. The results of this research indicate serious difficulties in the functioning of parents of children with disabilities, such as pain, emotional and physical discomfort, anxiety, depression, and problems resulting from the realization of everyday life activities combined with the care of the child. They indicate how serious this crisis is and how important life constraints it brings to the individual and the social functioning of the family.
A parent's ability to adapt to stressful situations depends on several variables, including an individual's psychological strengths, individual and family resources, and the type of coping strategies utilized. Parental burnout is defined as a syndrome that occurs in response to chronic parental stress. The risk of parental burnout is related to family functioning. In the concept of family as an interactional system, "family adaptability is the degree to which the family is flexible and can regain equilibrium in stressful and challenging situations or environments".
Positive coping styles such as positive perceptions and effective problem-solving skills were associated with successful family adaptation and resilience. Twenty years ago, the concept of mindful parenting was introduced as an alternative to traditional discipline-oriented methods by focusing on the quality of a parent's presence in the parent-child dyad. It focuses on cultivating mindfulness and attunement with the parent's inner experience while interacting with the child, and feeling the full range of emotions related to parenting. Mindful parenting involves cultivating non-judgmental awareness of the unfolding of internal and external experiences in daily life, practicing emotion regulation skills, learning about adaptive responses to distress, and developing a self-compassionate attitude toward one's fallibility, limitations, and suffering.
Compassion- and mindfulness-based interventions (CMBIs) hold promise in supporting parental resilience by enabling adaptive stress appraisal and coping, mindful parenting, and self-compassion. These interventions also aimed to reduce social isolation by increasing the capacity for connections. Perceived social support, an aspect of compassionate behavior, is a potent buffer against stress on health outcomes.
Therefore, the main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities. The investigators hypothesize that the mindfulness-based teleintervention compared with the control group will lead to (A) an improvement in positive aspects of mental health, including quality of life, and self-compassion, and (B) a reduction in psychopathological variables including perceived stress and parental burnout.
- Conditions
- Parental Burnout, Caregiver Burnout
- Being tested
- Mindfulness and Compassionate Living Course (MCLC), Usual care intervention
- Keywords
- parental burnout, meditation, mindfulness, self-compassion, stress level, parents of children with disability, autism, quality of life
- Medical subject headings
- Caregiver Burden, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Compassionate Living Course (MCLC)Behavioural
The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours) between sessions 6 and 7.
On the structural level, every course session consists of four elements: (1) an educational input, (2) mindfulness and compassion exercises (eg, sitting meditation, body scan, mindful walking, self-compassion break), (3) a reflection of one's practice (inquiry), (4) and home assignments.
Usual care interventionBehavioural
If necessary, psychological support is organized at the request of the parent.
Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based teleintervention | Experimental | 8-week Mindfulness and Compassionate Living Course (MCLC). The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours). Receives: Behavioral: Mindfulness and Compassionate Living Course (MCLC) |
| Usual care intervention | Active comparator | The facility provides psychological support for parents as needed and at the request of the parent. Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week). Receives: Behavioral: Usual care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Families in Early Intervention Quality of Life (FEIQoL)
Families in Early Intervention Quality of Life (FEIQoL) questionnaire will be used for assessing the quality of life. Participants answer 40 items using a five-point Likert scale (1, 'poor' to 5, 'excellent') in the aspects of family life (24 items), and child's functioning (16 items).
Measured: 15 minutes
Secondary outcomes (4)
Parental Burnout Measure (PBM-12)
Parental Burnout will be assessed with the Parental Burnout Measure (PBM-12) measures parental burnout in two dimensions: exhaustion and helplessness. Both dimensions are measured as a sum of 6 items, answered on a 4-point Likert scale (1, 'never' to 4, 'very often'). Fully satisfactory internal reliability indicators (Cronbach's alpha) were reached by all burnout measures - PBM-12 total score (.90), exhaustion subscale (.88), and helplessness sub-scale (.80).
Measured: 7 minutes
Self-Compassion Scale (SCS)
To assess self-compassion we will use a polish adaptation of the Self-Compassion Scale (SCS). Items on the SCS use a five-point Likert scale to measure conformity (1, 'almost never' to 5, 'almost always'). The final SCS score ranges from 26 to 130. A higher score indicates a higher level of self-compassion. This scale has good internal consistency and test-retest reliability (.93).
Measured: 7 minutes
Perceived Stress Scale (PSS-10)
The 10-item Perceived Stress Scale (PSS-10) will be used to measure self-reported stress. This scale includes 10 questions, with answers ranked using a 5-point Likert scale, and assesses stressful experiences and responses to stress over the previous 4 weeks. Scores range from 0 to 56, with higher scores indicating higher levels of perceived stress.
Measured: 7 minutes
Ego Resilience Scale (ER89)
The Ego-Resiliency Scale (ER89) measures the construct of ego-resiliency, which refers to the dynamic capacity of an individual to modify a characteristic level of ego-control, in either direction, as a function of the demand characteristics of the environmental context, so as to preserve or enhance system equilibration. It consists of 14 items, each responded to on a 4-point scale (1 = "does not apply at all"; 2 = "applies slightly, if at all"; 3 = "applies somewhat"; and 4 = "applies very strongly").
Measured: 7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Oct 2021
- Primary completion30 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parental BurnoutStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Silesia in Katowice, Jan Dlugosz University in Czestochowa
- Responsible party
- Principal investigator, Błażej Cieślik, Wroclaw University of Health and Sport Sciences
- Investigators
- Małgorzata Sekułowicz, Professor, Study chair, Wroclaw University of Health and Sport SciencesKrystyna Boroń-Krupińska, PhD, Principal investigator, Wroclaw University of Health and Sport SciencesSylwia Wrona, PhD, Principal investigator, University of Silesia in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620368
- Sponsor's protocol ID
- 01/2021
- Status last verified
- Dec 2022
- First submitted
- 9 Nov 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zessin U, Dickhauser O, Garbade S. The Relationship Between Self-Compassion and Well-Being: A Meta-Analysis. Appl Psychol Health Well Being. 2015 Nov;7(3):340-64. doi: 10.1111/aphw.12051. Epub 2015 Aug 26.
PubMed 26311196Allen AB, Leary MR. Self-Compassion, Stress, and Coping. Soc Personal Psychol Compass. 2010 Feb 1;4(2):107-118. doi: 10.1111/j.1751-9004.2009.00246.x.
PubMed 20686629Neece CL, Chan N, Klein K, Roberts L, Fenning RM. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: Understanding the Experiences of Latino Families. Mindfulness (N Y). 2019 Jun;10(6):1017-1030. doi: 10.1007/s12671-018-1011-3. Epub 2018 Sep 6.
PubMed 31191735Bohadana G, Morrissey S, Paynter J. Self-compassion: A Novel Predictor of Stress and Quality of Life in Parents of Children with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Oct;49(10):4039-4052. doi: 10.1007/s10803-019-04121-x.
PubMed 31267283Bohadana G, Morrissey S, Paynter J. Self-Compassion in Mothers of Children with Autism Spectrum Disorder: A Qualitative Analysis. J Autism Dev Disord. 2021 Apr;51(4):1290-1303. doi: 10.1007/s10803-020-04612-2.
PubMed 32656737Bogels SM, Lehtonen A, Restifo K. Mindful Parenting in Mental Health Care. Mindfulness (N Y). 2010 Jun;1(2):107-120. doi: 10.1007/s12671-010-0014-5. Epub 2010 May 25.
PubMed 21125026Wang H, Wang Q, Hu X, Han ZR. Mindfulness and Stress Among Parents of Children with Autism Spectrum Disorder in China. J Autism Dev Disord. 2022 May;52(5):2035-2045. doi: 10.1007/s10803-021-05011-x. Epub 2021 May 29.
PubMed 34050845Cousineau TM, Hobbs LM, Arthur KC. The Role of Compassion and Mindfulness in Building Parental Resilience When Caring for Children With Chronic Conditions: A Conceptual Model. Front Psychol. 2019 Aug 5;10:1602. doi: 10.3389/fpsyg.2019.01602. eCollection 2019.
PubMed 31428005Duncan LG, Coatsworth JD, Greenberg MT. A model of mindful parenting: implications for parent-child relationships and prevention research. Clin Child Fam Psychol Rev. 2009 Sep;12(3):255-70. doi: 10.1007/s10567-009-0046-3.
PubMed 19412664Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686.
PubMed 32876685Friis AM, Johnson MH, Cutfield RG, Consedine NS. Kindness Matters: A Randomized Controlled Trial of a Mindful Self-Compassion Intervention Improves Depression, Distress, and HbA1c Among Patients With Diabetes. Diabetes Care. 2016 Nov;39(11):1963-1971. doi: 10.2337/dc16-0416. Epub 2016 Jun 22.
PubMed 27335319Homan KJ, Sirois FM. Self-compassion and physical health: Exploring the roles of perceived stress and health-promoting behaviors. Health Psychol Open. 2017 Sep 14;4(2):2055102917729542. doi: 10.1177/2055102917729542. eCollection 2017 Jul-Dec.
PubMed 29379620Ten Hoopen LW, de Nijs PFA, Duvekot J, Greaves-Lord K, Hillegers MHJ, Brouwer WBF, Hakkaart-van Roijen L. Children with an Autism Spectrum Disorder and Their Caregivers: Capturing Health-Related and Care-Related Quality of Life. J Autism Dev Disord. 2020 Jan;50(1):263-277. doi: 10.1007/s10803-019-04249-w.
PubMed 31625009Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4.
PubMed 30900195Robinson S, Hastings RP, Weiss JA, Pagavathsing J, Lunsky Y. Self-compassion and psychological distress in parents of young people and adults with intellectual and developmental disabilities. J Appl Res Intellect Disabil. 2018 May;31(3):454-458. doi: 10.1111/jar.12423. Epub 2017 Nov 9.
PubMed 29119672
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Online Support Program for Mothers of Children With Disabilities
- ClinicalTrials.gov ID
- NCT05620368
- Acronym / sponsor ID
- 01/2021
- Conditions
- Parental Burnout, Caregiver Burnout
- Keywords
- parental burnout, meditation, mindfulness, self-compassion, stress level, parents of children with disability, autism, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- University of Silesia in Katowice, Jan Dlugosz University in Czestochowa
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 17 Nov 2022 (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 main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities.
Detailed description
Parenthood is accompanied by significant mental and physical effort accompanied by different sources of long-term stress and encumbrance. The results of this research indicate serious difficulties in the functioning of parents of children with disabilities, such as pain, emotional and physical discomfort, anxiety, depression, and problems resulting from the realization of everyday life activities combined with the care of the child. They indicate how serious this crisis is and how important life constraints it brings to the individual and the social functioning of the family.
A parent's ability to adapt to stressful situations depends on several variables, including an individual's psychological strengths, individual and family resources, and the type of coping strategies utilized. Parental burnout is defined as a syndrome that occurs in response to chronic parental stress. The risk of parental burnout is related to family functioning. In the concept of family as an interactional system, "family adaptability is the degree to which the family is flexible and can regain equilibrium in stressful and challenging situations or environments".
Positive coping styles such as positive perceptions and effective problem-solving skills were associated with successful family adaptation and resilience. Twenty years ago, the concept of mindful parenting was introduced as an alternative to traditional discipline-oriented methods by focusing on the quality of a parent's presence in the parent-child dyad. It focuses on cultivating mindfulness and attunement with the parent's inner experience while interacting with the child, and feeling the full range of emotions related to parenting. Mindful parenting involves cultivating non-judgmental awareness of the unfolding of internal and external experiences in daily life, practicing emotion regulation skills, learning about adaptive responses to distress, and developing a self-compassionate attitude toward one's fallibility, limitations, and suffering.
Compassion- and mindfulness-based interventions (CMBIs) hold promise in supporting parental resilience by enabling adaptive stress appraisal and coping, mindful parenting, and self-compassion. These interventions also aimed to reduce social isolation by increasing the capacity for connections. Perceived social support, an aspect of compassionate behavior, is a potent buffer against stress on health outcomes.
Therefore, the main objective of this study is to evaluate the effectiveness of an eight-week mindfulness-based teleintervention in improving quality of life, parental burnout, self-compassion, and stress level in mothers of children with disabilities. The investigators hypothesize that the mindfulness-based teleintervention compared with the control group will lead to (A) an improvement in positive aspects of mental health, including quality of life, and self-compassion, and (B) a reduction in psychopathological variables including perceived stress and parental burnout.
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 teleintervention | Experimental | Behavioral: Mindfulness and Compassionate Living Course (MCLC)8-week Mindfulness and Compassionate Living Course (MCLC). The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours). |
| Usual care intervention | Active comparator | Behavioral: Usual care interventionThe facility provides psychological support for parents as needed and at the request of the parent. Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- mother of childern with disabilities
Key exclusion criteria (3 listed)
- substance abuse;
- participation in another therapeutic project or individual psychotherapy;
- antidepressant treatment.
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 and Compassionate Living Course (MCLC)The course will be held online (using the Zoom platform) with weekly sessions lasting 2.5 hours each, as well as a day of silent practice (mini-retreat of 4 hours) between sessions 6 and 7. On the structural level, every course session consists of four elements: (1) an educational input, (2) mindfulness and compassion exercises (eg, sitting meditation, body scan, mindful walking, self-compassion break), (3) a reflection of one's practice (inquiry), (4) and home assignments. | Behavioural | Mindfulness-based teleintervention |
| Usual care interventionIf necessary, psychological support is organized at the request of the parent. Support includes individual support of a psychologist (1h / week), consultation with a teacher (special pedagogue and early school education teacher, 1h / week), individual consultation with observation of a child with a Venetian mirror (1h / week). | Behavioural | Usual care intervention |
Primary outcome
Families in Early Intervention Quality of Life (FEIQoL)
Time frame: 15 minutes
Families in Early Intervention Quality of Life (FEIQoL) questionnaire will be used for assessing the quality of life. Participants answer 40 items using a five-point Likert scale (1, 'poor' to 5, 'excellent') in the aspects of family life (24 items), and child's functioning (16 items).
4 secondary outcomes
Parental Burnout Measure (PBM-12)
Time frame: 7 minutes
Self-Compassion Scale (SCS)
Time frame: 7 minutes
Perceived Stress Scale (PSS-10)
Time frame: 7 minutes
Ego Resilience Scale (ER89)
Time frame: 7 minutes
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 20 Mar 2023.
- Background: PubMed 26311196Zessin U, Dickhauser O, Garbade S. The Relationship Between Self-Compassion and Well-Being: A Meta-Analysis. Appl Psychol Health Well Being. 2015 Nov;7(3):340-64. doi: 10.1111/aphw.12051. Epub 2015 Aug 26.
- Background: PubMed 20686629Allen AB, Leary MR. Self-Compassion, Stress, and Coping. Soc Personal Psychol Compass. 2010 Feb 1;4(2):107-118. doi: 10.1111/j.1751-9004.2009.00246.x.
- Background: PubMed 31191735Neece CL, Chan N, Klein K, Roberts L, Fenning RM. Mindfulness-Based Stress Reduction for Parents of Children with Developmental Delays: Understanding the Experiences of Latino Families. Mindfulness (N Y). 2019 Jun;10(6):1017-1030. doi: 10.1007/s12671-018-1011-3. Epub 2018 Sep 6.
- Background: PubMed 31267283Bohadana G, Morrissey S, Paynter J. Self-compassion: A Novel Predictor of Stress and Quality of Life in Parents of Children with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Oct;49(10):4039-4052. doi: 10.1007/s10803-019-04121-x.
- Background: PubMed 32656737Bohadana G, Morrissey S, Paynter J. Self-Compassion in Mothers of Children with Autism Spectrum Disorder: A Qualitative Analysis. J Autism Dev Disord. 2021 Apr;51(4):1290-1303. doi: 10.1007/s10803-020-04612-2.
- Background: PubMed 21125026Bogels SM, Lehtonen A, Restifo K. Mindful Parenting in Mental Health Care. Mindfulness (N Y). 2010 Jun;1(2):107-120. doi: 10.1007/s12671-010-0014-5. Epub 2010 May 25.
- Background: PubMed 34050845Wang H, Wang Q, Hu X, Han ZR. Mindfulness and Stress Among Parents of Children with Autism Spectrum Disorder in China. J Autism Dev Disord. 2022 May;52(5):2035-2045. doi: 10.1007/s10803-021-05011-x. Epub 2021 May 29.
- Background: PubMed 31428005Cousineau TM, Hobbs LM, Arthur KC. The Role of Compassion and Mindfulness in Building Parental Resilience When Caring for Children With Chronic Conditions: A Conceptual Model. Front Psychol. 2019 Aug 5;10:1602. doi: 10.3389/fpsyg.2019.01602. eCollection 2019.
- Background: PubMed 19412664Duncan LG, Coatsworth JD, Greenberg MT. A model of mindful parenting: implications for parent-child relationships and prevention research. Clin Child Fam Psychol Rev. 2009 Sep;12(3):255-70. doi: 10.1007/s10567-009-0046-3.
- Background: PubMed 32876685Ettman CK, Abdalla SM, Cohen GH, Sampson L, Vivier PM, Galea S. Prevalence of Depression Symptoms in US Adults Before and During the COVID-19 Pandemic. JAMA Netw Open. 2020 Sep 1;3(9):e2019686. doi: 10.1001/jamanetworkopen.2020.19686.
- Background: PubMed 27335319Friis AM, Johnson MH, Cutfield RG, Consedine NS. Kindness Matters: A Randomized Controlled Trial of a Mindful Self-Compassion Intervention Improves Depression, Distress, and HbA1c Among Patients With Diabetes. Diabetes Care. 2016 Nov;39(11):1963-1971. doi: 10.2337/dc16-0416. Epub 2016 Jun 22.
- Background: PubMed 29379620Homan KJ, Sirois FM. Self-compassion and physical health: Exploring the roles of perceived stress and health-promoting behaviors. Health Psychol Open. 2017 Sep 14;4(2):2055102917729542. doi: 10.1177/2055102917729542. eCollection 2017 Jul-Dec.
- 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.
Małgorzata Sekułowicz, Professor study chair
Wroclaw University of Health and Sport Sciences
Krystyna Boroń-Krupińska, PhD principal investigator
Wroclaw University of Health and Sport Sciences
Sylwia Wrona, PhD principal investigator
University of Silesia in Katowice
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Compassionate Living Course (MCLC) in people with Parental Burnout and Caregiver Burnout, run by Wroclaw University of Health and Sport Sciences at 3 sites in Poland.
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 3 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: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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?
Families in Early Intervention Quality of Life (FEIQoL) (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620368, which also lists 16 linked publications.
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 20 Mar 2023.