Mindful Self-Compassion Research Articles

A randomized controlled trial on single-session mindfulness self-compassion interventions for Fibromyalgia Syndrome: evaluating interoceptive awareness, anxiety, and pain

AbstractObjectives: This randomized controlled trial evaluates a single-session Mindfulness Self-Compassion (MSC) intervention for enhancing interoceptive awareness (AI) and alleviating anxiety and reducing pain in Fibromyalgia Syndrome (FMS) patients. The study also examines the intervention’s feasibility and the mediating role of IA in improving clinical outcomes, incorporating nature visuals to address treatment accessibility and adherence. Methods/analysis: Sixty-four FMS patients were randomized into three groups: MSC with audio-only, MSC with audio and nature visuals, or a waitlist control. Validated scales measured interoceptive awareness, anxiety, and pain pre- and post-intervention. ANOVA examined primary outcomes, and mediation analysis explored interoceptive awareness as a mediator. A 7-minute intervention duration was chosen for its balance of effectiveness and feasibility, with nature visuals selected for their calming effects. Findings: Both MSC groups showed significant improvements in IA, anxiety, and pain compared to the control group, with the audio-visual group showing the strongest effects. Enhanced interoceptive awareness significantly mediated anxiety reduction but not pain relief. Nature visuals further reduced anxiety and pain compared to audio-only. Novelty/improvement: This study validates the efficacy of a single-session MSC intervention for FMS, highlighting IA as a crucial mediator of anxiety improvement. Incorporating sensory-rich visual elements enhances therapeutic effects, offering a promising approach for MSC interventions in clinical settings. Future research should explore long-term benefits and optimal dosage of this innovative intervention, addressing the need for accessible, cost-effective FMS treatments.

Neural correlates of reduction in self-judgment after mindful self-compassion training: a pilot study with resting state fMRI

Neural correlates of reduction in self-judgment after mindful self-compassion training: a pilot study with resting state fMRI

Impact of a mindful self-compassion workshop incorporating sandtray on burnout in undergraduate nursing students: A mixed methods, pre-post study

AimTo assess the impact of a 4-hour, hands-on mindful self-compassion workshop incorporating sand tray exercises on undergraduate nursing student understanding of mindfulness and self-compassion, as well as feelings of burnout. BackgroundBurnout is the primary reason nurses leave the profession. Given widespread nursing shortages, it is important to address burnout early, with proven approaches. Mindfulness-based interventions have shown to reduce burnout in healthcare workers. DesignThis is a mixed methods interventional study with a pre-post design. MethodsA pre- and 2-month post-survey of demographic, lifestyle questions and the Maslach Burnout Inventory-Student Edition (MBI-S) was administered to participants and controls. Open-ended questions assessed participants’ understanding of the concepts of mindfulness and self-compassion. A qualitative post-workshop survey assessed participants’ reactions to the workshop. Multivariate regression analysis using a difference-in-differences approach assessed changes in the domains of burnout and overall feelings of burnout. Thematic analysis assessed changes in understanding of mindfulness and self-compassion and effectiveness of the workshop. ResultsA convenience sample of 133 undergraduate nursing students (68 participants, 65 controls) was recruited. The proportion of respondents indicating they feel burned out once a week or more was significantly lower for participants post-intervention than controls, with participants experiencing 71 % reduced odds (OR =.289, P=.085). Additionally, the intervention improved understanding of mindfulness and self-compassion and was considered effective at improving emotional awareness and control. ConclusionA mindful self-compassion workshop using sandtray exercises improved student nurse understanding of these concepts, was well-received and decreased the frequency with which students feel burned out.

A Mixed-Method Mindful Self-Compassion Art Therapy Postpilot Program Evaluation Study: Metaphors and Media to Increase Adults’ Acquisition of MSC Program Benefits (Étude d’évaluation post-pilote d’un programme d’art-thérapie d’auto-compassion à méthodes mixtes : métaphores et médias pour accroître l’acquisition des avantages du programme MSC pour les adultes)

This mixed-method quasi-experimental design pilot study evaluates the integration of the Mindful Self-Compassion (MSC) program with art therapy, utilizing the Expressive Therapies Continuum (ETC) to select media and metaphors that enhance self-compassion and emotional well-being. A MSC Art Therapy Group was held with 11 adult participants (male = 18.2%, female = 81.8%). Postgroup feedback was collected through a survey with Likert scale and open-ended questions. The ETC framework informed the selection of art materials and metaphors to promote therapeutic benefits. Feedback from 18.2% of participants produced mean scores of 90% for both helpfulness and enjoyment. Qualitative responses highlighted the facilitation of community, creative expression, and emotional processing, which may have affected increased self-compassion and emotional resilience. The pilot study suggests that merging MSC with art therapy can positively impact self-compassion and emotional well-being. The limitations include a small sample size, lack of a control group, and potential self-selection bias. Future research should involve larger, more diverse populations and rigorous control measures. This study provides initial support for combining MSC with art therapy and highlights the value of intentional media and metaphor selection in enhancing therapeutic outcomes.

Early appearance concerns after burns: Investigating the roles of psychological flexibility and self-compassion

Few qualitative studies have explored appearance concerns soon after burn injuries. This study aimed to understand the early experiences of appearance concerns after burns, through the lens of psychological flexibility and self-compassion. Template analysis informed data collection and analysis. Fifteen adults (nine female, six male) with appearance concerns were interviewed within three months of their burns. Three superordinate themes were identified: (1) Need for social connection; (2) Distress through difference; and (3) Experiential avoidance and self-criticism in response to early appearance concerns. Findings highlighted that early appearance concerns are influenced by the need for social acceptance and the desire to conform to societal ideals. Internalised gender and appearance ideals and concerns about rejection and stigma were activated by the burn, and individuals had difficulty responding to their early appearance concerns with psychological flexibility and self-compassion. Instead, attempts to avoid distress (experiential avoidance) occurred. Self-criticism in response to distress was evident which, for some, extended to the event leading to their burns. Early interventions to enhance psychological flexibility and self-compassion (e.g., acceptance and commitment therapy, mindful self-compassion), to help individuals respond to appearance concerns with less experiential avoidance and self-criticism, would likely promote adjustment to changes in appearance after burns.

Reducing Suicide Ideation in Transgender Adolescents with Mindful Self-Compassion: An Open Trial

Reducing Suicide Ideation in Transgender Adolescents with Mindful Self-Compassion: An Open Trial

Effects of Mindful Self-Compassion Training on Increasing Self-Compassion Among Health Professions Students: A Pilot Study

Abstract Date Presented 03/21/24 A five-week mindful self-compassion (MSC) training significantly improved self-compassion among health professions students, demonstrating its potential as an effective tool for promoting student well-being and supporting academic and clinical success. Primary Author and Speaker: Danielle Losonci

Effects of online mindful self-compassion intervention on negative body image in breast cancer patients: A randomized controlled trail

PurposeThe incidence of breast cancer patients with negative body image has increased. However, research on interventions that explicitly reduce negative body image among breast cancer patients remains inadequate. The development of more pragmatic interventions is imperative. Therefore, we conducted this study to assess the effectiveness of a 6-week online Mindful Self-Compassion (MSC) intervention to reduce the negative body image in breast cancer patients. MethodsWe randomly assigned 64 female breast cancer patients to either the MSC group or the control group. The MSC group received a 6-week online Mindful Self-Compassion intervention, while the control group received no psychological training. Participants were surveyed by the Self-Compassion Scale-Short Form (SCS-SF), the Self-Acceptance Questionnaire (SAQ), the Chinese Perceived Stress Scale (CPSS), and the Body Image Scale (BIS) at baseline (T1), post-intervention (T2), and 1-month follow-up (T3). ResultsAll outcome variables demonstrated significant time main effects and nonsignificant group main effects. The MSC and control groups had significant time × group interaction effects on self-compassion, self-acceptance, perceived stress, and negative body image. Simple main effects analysis revealed significant improvements in outcome variables at three-time points for the MSC group. ConclusionA 6-week online Mindful Self-Compassion intervention can improve self-compassion and self-acceptance and reduce perceived stress and negative body image among the breast cancer patients in MSC group. Mindful Self-Compassion intervention shows promise as a viable way to maintain the mental well-being of breast cancer patients.

Effects of a Virtual Mindful Self-Compassion Training on Mindfulness, Self-compassion, Empathy, Well-being, and Stress in Uruguayan Primary School Teachers During COVID-19 Times

Effects of a Virtual Mindful Self-Compassion Training on Mindfulness, Self-compassion, Empathy, Well-being, and Stress in Uruguayan Primary School Teachers During COVID-19 Times

자기자비 마음챙김 훈련집단과 자기자비 ACT집단에서 심리적 안녕감, 자기자비와 수용의 변화 과정

Self-compassion is a treatment mechanism closely related to acceptance, so it needs to be used as a component of Acceptance Commitment Therapy (ACT) explicitly and integratively. This study explored changes in psychological well-being, self-compassion, and acceptance among three groups: mindful self-compassion training (n=11), ACT-based self-compassion (n=8), and control (n=8) undergraduates. Mindful self-compassion training comprised 8 sessions of 16 to 20 minutes each, while ACT-based self-compassion group program involved 8 sessions of 90 minutes per week. Using latent growth modeling, changes were analyzed at four time points: pre, mid, post, and follow-up. Results showed that in the training group, the three variables increased but rapidly decreased at follow-up. In the ACT group, self-compassion increased and then decreased slowly at follow-up. These findings suggest mindful self-compassion training enhances psychological well-being, self-compassion, and acceptance. Incorporating self-compassion interventions into ACT helps maintain self-compassion effects over time.

Mindful self-compassion program based on Watson's theory of human caring in nursing students: A randomized controlled study

Aims and backgroundThis study investigated the impact of the Mindful Self-Compassion Program, based on Watson's Theory of Human Caring Model, on the physical and mental health of nursing students. The essence of nursing is care and compassion. While there are studies on compassion in nursing care, nurses' self-compassion is an underrecognized concept in the literature. MethodsThe study employed a randomized controlled design and involved 80 seconds-grade nursing students from a university in Turkey between December 2021 and June 2022. The intervention group received an online program consisting of six weekly sessions, while the control group did not receive any intervention. The data were collected using the Promotive and Protective Health Behaviors Scale, Watson Caritas Self-Rating Score, Brief Resilience Scale, and Self-Compassion Scale before, at the end of, and 5 months after the program. ResultsIn both the post-test and follow-up test, the intervention group exhibited an increase in health-promoting and protective behaviors, self-care perception, psychological resilience, and self-compassion compared to the control group. ConclusionTherefore, it is recommended to use the program to improve the physical and mental health of individuals in nursing practice areas. Additionally, it would be beneficial to include the program in the nursing education curriculum. Our findings provide evidence supporting the use of the program for nursing students and nurses.

Addressing Ethical Concerns in Implementing Mindfulness-Based Interventions in Educational Setting

The burgeoning interest in mindfulness and the way it has been stripped from its Buddhist ontological roots and popularized in the West has recently raised ethical concerns regarding its application in various domains, and more specifically in the educational field. We will address in this article three main ethical concerns regarding implementing mindfulness-based interventions (MBIs) in the educational field. Firstly, how do we help educators and students cultivate personal awareness while at the same time being conscious of the needs of others and promote a pro-social orientation? Secondly, how do we ethically implement MBIs in the current neoliberal social, cultural, and political context? Thirdly, how do we implement MBIs in a culturally sensitive manner respecting the ethics of other ethnic groups and other societies? We will attempt to offer solutions to those issues by exemplifying how MBIs are integrated with compassion-based interventions (e.g., mindful self-compassion (MSC)) and social-emotional learning (understanding and managing emotions, building positive relationships, and making responsible decisions) among educators and students in Jewish and Arab schools in Israel. We will discuss three MBI programs that incorporate strategies addressing social ailments such as stereotyping and prejudicial attitudes and promote pro-social behavior as well as share research findings regarding their efficacy. Additionally, we will outline ways in which these mindfulness-based programs were adapted to suit different populations. Finally, we will conclude by pointing to future means to address these issues.

Effectiveness of mindful self-compassion therapy on psychopathology symptoms, psychological distress and life expectancy in infertile women treated with in vitro fertilization: a two-arm double-blind parallel randomized controlled trial

ObjectivesInfertility is a prominent problem affecting millions of couples worldwide. Recently, there has been a hightened emphasis on elucidating the subtle linkages between infertility treatment leveraging assisted reproductive technology and the complex realm of psychological challenges, as well as efforts in implementation of psychological interventions.The Mindful Self-Compassion (MSC) program seeks to improve self-compassion, compassion for others, mindfulness, and life satisfaction while reducing depression, anxiety, and stress. In the current study, an MSC intervention was performed on infertile women (IW) undergoing in vitro fertilization (IVF) to assess the effectiveness of this intervention in reducing psychological distress and psychopathological symptoms and enhancing life expectancy.MethodsFifty-seven IW undergoing IVF were randomly allocated to two groups: MSC (n = 29) or treatment as usual (TAU; n = 28). Participants in MSC met once a week for two hours for eight weeks and attended a half-day meditation retreat. The Synder's Hope questionnaire and the Revised 90-Symptom Checklist (SCL-90-R) were used as the primary outcome measures. Data were obtained before the intervention, immediately after the intervention, and two months post-intervention. Repeated measures of ANCOVA and paired t-tests in all assessment points were used to compare the MSC and the TAU groups in outcomes.ResultsIn the MSC group, hopelessness, anger-hostility, anxiety, interpersonal sensitivity difficulties, and depression were significantly reduced compared with the TAU group, and those improvements persisted at the two-month follow-up. Reliable change index revealed that the MSC group's gains were both clinically significant and durable.ConclusionsMSC can facilitate higher life satisfaction and mental well-being for IW undergoing IVF by reducing psychological distress, psychopathological symptoms, and hopelessness. These encouraging findings call for more research into the effectiveness of mindfulness-based therapies in addressing psychological problems among IW undergoing IVF.

The Effect of a Mindful Self-Compassion Intervention on Burden, Express Emotion and Mental Well-Being in Family Caregivers of Patients with Schizophrenia: A Randomized Controlled Trial.

The objective of this randomized controlled trial was to examine the impact of a mindful self-compassion intervention on burden, express emotion, and mental well-being in family caregivers of patients with schizophrenia. Standardized measures, including the ZARIT Caregiving Burden Scale, Expressed Emotion Scale and Warwick-Edinburgh Mental Well-Being Scale, were administered at baseline, post-intervention. Statistical analysis was conducted to assess differences between the two groups. Significant reductions in caregiver burden, expressed emotion, and enhanced mental well-being in the intervention group compared to the control group at post-intervention. The results of this randomized controlled trial indicate that the mindful self-compassion intervention significantly reduces caregiver burden, expressed emotion, and improves mental well-being in family caregivers of patients with schizophrenia. These findings underscore the potential utility of mindful self-compassion interventions as effective support for this population, highlighting the importance of integrating such interventions into caregiver support programs.

Mindful self-compassion for veteran women with a history of military sexual trauma: feasibility, acceptability, potential benefits, and considerations

ABSTRACT Background: Military sexual trauma (MST) is reported by up to 74% of women veterans in the United States and is a driver of poor behavioural and physical health. Self-compassion is a transdiagnostic, protective factor linked with improved posttraumatic stress disorder (PTSD), depression, and health behaviours. Thus, Mindful Self-Compassion training (MSC) may help ameliorate MST-related impacts. However, MSC can also temporarily increase distress (i.e. backdraft). Delivering it with elective trauma-informed yoga (TIY), which regulates acute distress, may help address this issue. Objective: This VA quality improvement project examined feasibility, acceptability, and reported benefits and challenges of a manualized 8-week MSC including within non-randomized subgroups: MSC (n = 4) and MSC+ elective TIY classes (MSC+; n = 4). Methods: Nine women veterans with a history of MST at a Vet Center in the Northeastern U.S.A. enrolled; eight completed, excluding one MSC+ participant. Measures included attrition (n = 9), attendance (n = 8), weekly (n = 8) and posttreatment acceptability (n = 6), validated symptom severity assessments (n = 7), and an exit interview (n = 8). Results: Among completers, MSC attendance was excellent (89%) and higher among in MSC+ vs. MSC (94% vs. 84% sessions completed). On average across the two groups, depressive and PTSD symptom severity decreased by 21% and 30%, respectively. In exit interviews, participants across groups described improved coping with distress and psychiatric symptoms, reduced stress, and improved self-care and health behaviours. Although women in both groups reported backdraft during the programme, MSC+ also reported healthier coping and improved emotional processing. Conclusion: The results of this programme evaluation infer MSC may be feasible, acceptable, and beneficial for women survivors of MST in one Vet Center in the Northeastern USA. Further, temporary elevations in MSC-related distress may be ameliorated with adjunctive TIY. Given requests of women veterans in the USA. for additional complementary and integrative health treatment options, formal research on these approaches is warranted.

Mindful self-compassion for psychological distress -associated with skin conditions: An online intervention study.

Background Chronic skin conditions are different from internal illnesses since they are often immediately visible to others. Patients feel self-conscious and often go through depression, anxiety, fear of stigma and a substantial psychological, social and economic impact. It is crucial for healthcare professionals to gather information about various strategies and psychosocial interventions that can be used to manage psychological distress associated with skin conditions and avoid it from being neglected amidst other health conditions. Mindful Self-Compassion (MSC) can be used for this. It is a resource-building mindfulness-based self-compassion training programme that uses a combination of personal development training and psychotherapy designed to enhance one's capacity for self-compassion by cultivating spacious awareness as a basis for compassionate action. Aims This study examined the impact of mindful self-compassion on depression, anxiety, stress, dermatology-specific quality of life, self-esteem and well-being in a sample of 88 adults aged 18-55 years suffering from chronic skin conditions. Methods This study used an experimental waitlist control design. Participants were recruited from two skin clinics using purposive sampling in Mumbai, Maharashtra. Pre-test data was collected through self-reported questionnaires on psychological distress, dermatology-specific quality of life, self-esteem and well-being. Participants who were experiencing psychological distress were randomly assigned to either the experimental or waitlist control group. The intervention named 'mindful self-compassion' was delivered through an online platform, twice a week, over a period of 4 weeks. Post-test data was collected later on all variables. Results ANCOVA was utilised where pre-test scores were used as covariates. Differences in pre-test and post-test scores between the intervention group and waitlist control group for depression, anxiety, stress, dermatology-specific quality of life, self-esteem and well-being were analysed. Participants in the intervention group were found to have lower levels of depression, anxiety and stress as compared to the waitlist control group and also had enhanced levels of self-esteem, well-being and dermatological quality of life. These differences were found to be statistically significant (p < 0.001). Limitations The sample reflected heterogenous skin conditions, not a specific skin condition. The study was quantitative in nature, and we could not use any qualitative methods to assess the subjective experience of participants. Due to time constraints, follow-up data could not be gathered from participants to assess long-term effects on participants. Conclusion Mindful self-compassion can be effectively used to manage psychological distress in skin conditions. Dermatologists can become acquainted with basic signs of mental distress and the importance of psychological interventions. By collaborating with mental health professionals, patients can be given holistic treatment.

Improved Soft-Skill Competencies of ABA Professionals Following Training and Coaching: A Feasibility Study

The field of applied behavior analysis currently faces critique regarding the need for increased compassion and interprofessional collaboration training toward culturally and emotionally responsive practice. Mindful self-compassion is evidenced to improve self-compassion and compassion. The purpose of the current study was to improve soft-skill competencies in collaboration and compassion of behavior analytic professionals. In this feasibility study, two cohorts of American behavior analytic professionals (N = 24) received a 4-month training-and-coaching sequence, with a pre-program focus group serving as the program’s needs assessment. The Interprofessional Collaborative Competency Attainment Survey and Self-Compassion Scale, Short Form were administered pre- and post-intervention to ascertain program effectiveness, alongside open-ended survey questions. Training included experiential learning opportunities in small groups, with participants practicing self-compassion and collaboration skills. Coaching included additional individual practice opportunities. Pre- and post-whole test scores were significantly different on both instruments, with p set at .05, demonstrating preliminary effectiveness. Significance on paired-sample t-test for the Interprofessional Collaborative Competency Attainment Survey whole score fell at <.001, while for the Self-Compassion Scale, Short Form, it fell at .004. While prior studies have demonstrated the need for collaboration and compassion training within the ABA workforce, the current study reports on an implementation procedure to improve upon these skill sets, addressing a noted gap. Furthermore, the current study operationalizes collaboration alongside self-compassion, demonstrating the importance of centering collaborative practice within soft-skill awareness and competency. Future research can incorporate direct measures of these skill sets.

Self-Compassion-Based Interventions in Oncology: A Review of Current Practices

Self-compassion consists of an attitude of self-support and self-benevolence. In the general population, increased self-compassion has been associated with well-being and decreased psychopathology. In oncology, higher self-compassion has also been linked with various benefits, such as lower emotional distress, fatigue, body-image disturbances, and sleep difficulties. Self-compassion also seems to foster treatment adherence. Various interventions based on self-compassion have recently been designed and tested in different clinical and non-clinical populations. They are particularly relevant in oncology, as patients are increasingly interested in complementary approaches to help them manage their symptoms and difficulties benevolently and without judgment. In this review, we described various self-compassion-based interventions that have been or will be proposed to patients with cancer, as well as their first results. The main interventions that have been tested are compassion-focused therapy, the combination of self-hypnosis and self-compassion learning, mindful self-compassion training, cognitively-based compassion training, and loving-kindness meditation. Other interventions include a self-compassion-focused writing activity, a mobile self-compassion application, and a self-compassion group therapy focused on the fear of cancer recurrence. Many of these studies were quasi-experimental or protocols. However, existing results tend to suggest the benefits of these interventions to improve different symptoms often endured by patients with cancer. Further research is needed to conduct rigorous studies on these approaches and to determine how and for whom they are efficient.

Role of Compassion Fatigue and Burnout in Existing and Upcoming Interventions for Mental Health Professionals: A Literature Review

ABSTRACT Mental health professionals face several difficulties, particularly in the form of burnout and compassion fatigue (CF). The rate of burnout and CF is on the rise with changing times. Providing mental health services while being burnout or going through CF can be challenging. Therefore, there is a need to explore existing interventions for mental health professionals. This article aims to explore burnout and CF in relation to existing interventions for mental health professionals and highlight implications for further interventions. Recently, mindfulness interventions such as mindfulness-based stress reduction, mindfulness-based cognitive therapy, mindfulness self-compassion training, and interpersonal mindfulness program have been studied as a potential intervention for mental health professionals. Another recent intervention called as compassion-focused therapy is on the rise, and the article will research its efficacy in use with mental health professionals. The present article has implications in the field of positive psychology, clinical psychology, and health psychology.

Teaching Adolescents With Type 1 Diabetes Self-Compassion (TADS) to Reduce Diabetes Distress: Protocol for a Randomized Controlled Trial.

Adolescents living with type 1 diabetes (T1D) often experience diabetes distress (DD), a construct distinct from depression or anxiety that refers to the negative emotions that arise from living with and managing diabetes. Self-compassion, which involves being open to one's own suffering and treating oneself with the same care one would show to loved ones, is associated with better psychological and clinical outcomes among individuals with T1D. Self-compassion is a skill that can be taught and therefore represents an opportunity for intervention. The overall aim of this study is to assess the effectiveness of a web-based mindful self-compassion for teens (MSC-T) intervention on improving DD, anxiety, depression, diabetes-related disordered eating, and suicidal ideation experienced by youth with T1D (aged between 12 and 17 years) compared with a waitlist control group (standard of care). We will also explore (1) if the effect of the MSC-T intervention changes over time, (2) if the MSC-T intervention has a positive impact on measures of glycemic control, and (3) if the effect of the MSC-T intervention differs based on self-reported gender. We will conduct a single-center, parallel-group randomized controlled trial of 140 adolescents with T1D followed for 12 months. Participants will be randomly allocated (using hidden allocation) in a 1:1 ratio to either the MSC-T intervention or the waitlist control group. Our primary outcome is DD, as measured by the Problem Areas in Diabetes-Teen (PAID-T) version at 3 months. Secondary outcomes, assessed at 3 and 12 months, include anxiety (Generalized Anxiety Disorder 7-item [GAD-7] scale), depression (Patient Health Questionnaire-9 [PHQ-9]), diabetes-related disordered eating (Diabetes Eating Problem Survey-Revised [DEPS-R] version), and suicidal ideation (using 1 question from the PHQ-9). Study recruitment began in October 2022 and was completed in March 2023, with a total of 141 participants enrolling. Data collection will be ongoing until March 2024. The first results are expected in June 2024. This study will be the first randomized trial to assess the effectiveness of the web-based MSC-T intervention on adolescents with T1D. Given that adolescence is a period where individuals are typically required to assume more responsibility for their diabetes care, providing adolescents with the tools they need to better manage the stress that often accompanies T1D management is paramount. ClinicalTrials.gov NCT05463874; https://clinicaltrials.gov/study/NCT05463874. DERR1-10.2196/53935.