Mindfulness

This is a single center, randomized, open label study to assess the feasibility of a low-protein diet intervention in cancer patients who are receiving immunotherapies. Subjects will be randomized in a 1:1 ratio to either immunotherapy plus control diet arm (\~20% protein content) or immunotherapy plus intervention low-protein diet arm (10% protein content).

Parenting children with special health care needs can be stressful and weigh on the caregivers' mental health. For the individuals with special needs, the mismatch between their needs and the normative practice in the world around them can be frustrating and detrimental to their functioning. The demands and concerns to these families can be so real that it may not be sensible to examine the validity or helpfulness of the distressing thoughts or feelings but to promote psychological flexibility, which is a key to value-guided living. This pilot study explores the effects and feasibility of a group-based intervention for families of individuals with special health care needs.

This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.

Traditional Chinese medicine is effective for precocious puberty which is mild or moderate, but not effective for the one that is severe and rapidly progressing. Acupuncture can effectively regulate sex hormone levels and ovarian function, promote ovulation, and have therapeutic effect for polycystic ovary syndrome and irregular menstruation. Studies have shown that acupuncture and auricular point compression stimulation is effective for premature thelarche, yet there are few studies on idiopathic precocious puberty. Clinical evidence is still needed to support whether acupuncture point stimulation combined with traditional Chinese Medicine herbs can enhance the effect and prevent the progression into severe or rapidly progressing precocious puberty, hence the study is to be carried out.

Being a parent of the child with medical complexity poses enormous stress because CMC have a chronic complex health condition, which may result in premature death of the CMC. Psychological symptoms commonly experienced by the parents of a CMC. Having a CMC is an ongoing stressor including diagnosis, daily nursing care and symptom management, uncertainty of prognosis that can adequately fear the possibility of relapse. Therefore, seeking an intervention consisting of "Psychological flexibility" is crucial for these parents to manage their stress and difficult emotions more effectively. The ACT intervention help individuals concentrate more on their problems with positive attitude and take initiatives and workable actions to fix the problems associated from the caregiving activities. As a result, they will experience less stress when encountering difficulties and challenges and adapt more effectively. These individuals probably have the potential of natural recoveries from adverse events once the stressor is terminated. Knowledge gap: A review of the literature reveals a paucity of studies on ACT for Chinese parents of the CMC to decrease their psychological symptoms while enhancing their psychological flexibility in local communities. To fill the knowledge gap, this proposal therefore endeavors to develop an ACT and test its preliminary effects and feasibility.

State the primary objective(s) of the study: The objective of the study is to assess the effectiveness of "ACT with CF Self Help Toolkit" in improving cognitive fusion, depression, anxiety, psychological flexibility and value-based living among adults with cystic fibrosis. State the secondary objectives(s) of the study: The investigators are aiming to examine whether the ACT with CF Self Help Toolkit improves medication adherence, and spirometry results among adults with cystic fibrosis. Data collected from electronic health records will be used for analysis. What benefit or knowledge will be gained? Findings can inform psychosocial interventions for adults with cystic fibrosis and other chronic health conditions. State hypothesis tested: ACT with CF Self Help Toolkit will prove more effective than Waitlist Control in reducing cognitive fusion, depression and anxiety, and improving psychological flexibility and value-based living among adults with cystic fibrosis. Similarly, those in the Waitlist Control will, once they receive access to the Toolkit 6 weeks later, also demonstrate significant improvements in cognitive fusion, depression and anxiety, psychological flexibility and value-based living. Patients will be recruited from the following: Thomas Jefferson University Hospital Cystic Fibrosis Clinic, the Boomer Esiason Foundation social media pages (facebook, instagram), Cystic Fibrosis Foundation listserv (used by CF Clinic Mental Health Providers), CF Social Worker listserv, other mental health provider listservs, physicians who recruited patients for our previous clinical trials, and the Cystic Fibrosis Research Institute. Patients who are interested in participating must show that they have a diagnosis of cystic fibrosis (sharing a MyChart or similar record, referral from a CF physician specialist). If patients are willing to be in the study, they will be given a consent form to sign and return as well as a packet of screening questionnaires containing the GAD-7, PHQ-9, and some questions regarding their CF diagnosis to determine eligibility. If found eligible, they will then be sent a baseline measures packet containing demographic questions, questions regarding their feelings about ACT, the CF Mental Health and Wellness Self-Report Measure, the AAQ-II, the CFQ-13, the BDI-II, the BAI, the VLQ, the Styles of Coping Word Pairs Measure, the B-PQSI, and the CFQ-R. All packets will be sent to participants digitally using RedCap. These questionnaires will ask patients: 1) how often the participant experiences different thoughts and feelings, including some related to having cystic fibrosis; 2) how often the participant takes their cystic fibrosis medications; 3) the participant's coping style, including how long they persist in thinking about something that has happened to them. The participant will complete each questionnaire again after 6 weeks, and again about 3-months later. Some variation exists in the packets based on timepoint. Participants in the waitlist condition will receive a secondary baseline packet before starting the ACT with CF intervention. This packet includes all the same measures as the original waitlist packet, but also contains the GAD-7 and PHQ-9 to observe any change in measures collected during screening. 6 weeks after beginning treatment, all participants will complete another measures packet. This packet contains all previously used measures. Additionally, this packet includes the TEX-Q2 and a series of novel qualitative and quantitative measures to establish participant feelings about ACT with CF. All participants will complete their final packet 3 months after treatment. This packet will contain all previous measures, as well as some of the novel measures about ACT that were included in the 6 week packet. These questionnaires take about 45 minutes to complete. Participants in the Waitlist Control condition will also complete this packet prior to gaining access to the ACT with CF Self-Help Toolkit (so will complete measures at baseline, 6 weeks/start of Toolkit, 6 weeks later, and 3 months later). The ACT with CF Self-Help Toolkit will include 6 main modules, each with 3 or 4 kernels, which will be short videos, in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., anxiety, depression) and to engage in positive behaviors. These videos are based on the main interventions in our ACT with CF individual therapy protocol. For example, the first main module focuses on how the participant wants to live their life (Values Clarification Intervention), and the kernels in this module are 1-3 minute video clips demonstrating different ways to figure this out (Card Sort, 70th Birthday exercise, accessing barriers). De-identified data will be sent to UNC-Chapel Hill for analysis. In addition, the investigators estimate that power will be more favorable to characterize the associations between intervention process measures and treatment-related changes in psychological functioning throughout the active treatment period. Using similar assumptions to our primary model above, the investigators anticipate that a sample size of 42 individuals would be sufficient to examine associations from a linear, repeated measures, mixed modeling approach incorporating data from weeks one through six. The investigators will analyze the data with each subject serving as their own control, with the first packet of questionnaires prior to accessing the Toolkit being compared with the questionnaires immediately after having the Toolkit for 6 weeks and then three months later. The investigators will use a standard data analysis using a two-tailed t-test to see if there are significant differences between their responses in the first set of questionnaires before receiving the Toolkit to the second set after having access to the Toolkit for 6 weeks. Repeated measures mixed modeling will be used to examine changes in depressive and anxious symptoms over time, with psychological functioning measured as a mean rank score across all four measures. Within this model the investigators will control for baseline psychological functioning, age, gender, and FEV1 values, with treatment group as the predictor of interest. The investigators will also examine the interaction between frequency of ACT with CF Toolkit access (how often participants engage with the Toolkit) and outcome scores. In addition, explanatory analyses of process-related psychological mechanisms will be examined using general linear models

This randomized, double-blind clinical trial will look to examine the efficacy of the Alii supplement, compared to a placebo, on reducing symptoms related to nutritional depletion in hormonal birth control pill users. This clinical trial will be conducted on 68 female university students. Participants will fill out measures of happiness, mood swings, digestive health, vulnerability to disease, and energy at time 1. Participants will then be randomly assigned to take a placebo or the Alii supplement for 28 days. Specifically, participants will take three capsules per day, with or without food. Participants will receive daily reminders to take their capsules. After taking the placebo or the supplement for 28 days, participants will again fill out the same measures of happiness, mood swings, digestive health, vulnerability to disease, and energy. Differences in these outcomes over time will be assessed to determine if taking the Alii supplement can improve these outcomes.

Haematological malignancies have several unpleasant consequences on psychological and physical health. Indeed, an important fatigue and reduction of functional capacities appear. Reduction of functional capacities leads to the reduction of autonomy in Acts of Daily Living (ADL) and impact negatively the global Quality of Life (GQoL). Patients who undergo high dose treatment in protected area have higher risks of functional decline. In addition, hospital stay alone in sterile room favours increase of anxiety and depression. Health care strategies are going to integrate and use more of support care as APA and relaxation. Regular APA practice leads to maintain and/or improve physical functioning and psychological well-being. Physical Activity ensures to maintain or develop muscular strength and cardio-respiratory capacities that patients loose if they stay inactive during hospital stay. APA practice participates too in regulation of emotional states. Indeed, it favours positive emotions as self-esteem, self-confidence, satisfaction and pleasure. In the order to limit or reduce anxiety level, relaxation provides an effective response. Maintain functional capacities and reduce negatives emotional states participate to reduce fatigue too. Also, APA associated with relaxation seems to be a good effective support care strategy. The aim of this study is to implement a supervised APA program with entertaining devices as Exergaming and Biofeedback relaxation for patients undergo high dose treatment in protected area. Exergaming consists on exercise and training through fun or recreative situations. Biofeedback device is a relaxation tool that gives feedback on functioning of nervous system in real time. The objective is to leads patients to become aware of their body-information to finally, associate them to sensations and more effectively control them. The objectives of this study are to: 1. To reduce state anxiety level and psychological fatigue impact on GQoL and 2. To Maintain or improve functional capacities and reduce physical fatigue. The main hypotheses are: 1. Each of the three programs leads to the objectives specified above. 2. APA associated with biofeedback relaxation reduce more state anxiety level than APA with Exergaming that is more effective than APA classic. 3. APA with Exergaming and biofeedback practice gender more satisfaction and adhesion than APA classic The program takes place 3 times per week. Each session lasts between 30 and 60 min. Intensity of effort is defined as light to moderate. Participants are assigned to one of the tree groups: 1-APA classic / 2-APA with Exergaming / 3-APA and Biofeedback relaxation. Aerobic activity is performed on a cyclo-ergometer (Groups 1 and 3) classic or exergaming (group 2). At the end of session, patients in relaxation group (Group 3) realise relaxation as recovery whereas other groups rest and stretch. Functional capacities are assessed twice by submaximal tests: at the beginning and directly after APA program, just before hospital discharge. The first session affords to estimate subjects capacities and to create and individualised and adapted programme. The second affords to compare groups themselves and each other. Cardio-respiratory capacity is evaluated by the 2min Walk Test (2WT) and lower limbs muscular strength by the 5 Times Sit to Stand Test (FTSST). State anxiety level and fatigue are assessed by State and Trait Anxiety Inventory-YA (STAI-YA) and Multi-Fatigue Inventory\_20items (MFI-20) respectively. At the inclusion, we complete the profile of individuals with the Hospital Anxiety and Depression Scale (HADS). Adhesion and satisfaction are assessed by feedbacks of participants and by the comparison of the number of planned versus performed sessions.

The Apple Health Study aims to build a diverse and inclusive group of participants to help researchers advance our understanding of how signals and information collected from apps and devices relate to health and may be used to predict, detect, monitor, and manage changes in health. To enroll, US residents who have an iPhone can download the Apple Research app from the App Store and go through the introduction and informed consent for the Apple Health Study. This study is fully remote, and all are invited to enroll if the eligibility criteria are met. Participants will be asked to complete tasks and surveys, using their iPhone and Apple Research app which include: * Selecting the types of data they would like to share with the study such as health and sensor data * Completing tasks and surveys including areas such as personal demographic information, personal medical history, family history, and social determinants of health

Title of Study: Assessment of the Impact of Art-Based Pain Assessment Tool on Pain Communication, Joint Function, and Anxiety in Patients with Temporomandibular Disorders (TMD): A Randomized Controlled Trial Location: King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About? This study examines how an art-based tool can help improve communication and understanding of pain among patients with jaw joint disorders (TMD). It compares two groups: * Standard care: Routine diagnostic and therapeutic procedures * Intervention: Standard care plus a guided art-based tool using paintings to express and discuss the TMD experiences What Is the Art-Based Tool? This novel method, called the Artistic Pain Exploration (APE), uses paintings to help patients describe their pain that relates to TMD and its effect on their quality of life: 1. Participants will be shown three paintings (e.g., The Scream by Edvard Munch) 2. Participants will choose the one that best resonates with them 3. A guided discussion follows, exploring how the image relates to their physical and emotional pain as well as the effect of pain on their daily activities Research Questions: 1. Does using the APE method help participants better communicate and understand their pain? 2. Does it improve jaw function and reduce anxiety more than standard assessment? Who Can Participate? Participants may be eligible if they: * Are 18 years or older * Have early-stage TMD (not needing surgery) * Can give informed consent Participants cannot participate if they: * Require jaw surgery * Have severe mental illness (e.g., psychosis or bipolar disorder) * Take narcotic pain medications regularly What Will Happen During the Study? * Participants are randomly assigned to one of the two groups. * Each participant will complete a standardized questionnaire before and after two weeks to assess the level of anxiety. * All participants will be screened for depression via a standardized questionnaire before the first visit. * All will undergo a clinical exam to assess the TMJ pain and function and receive appropriate medications and lifestyle instructions. * Some participants (intervention group) will also discuss their pain using the artwork. * All participants will be seen for a follow up in 2 weeks to assess the TMJ function and pain. Potential Risks and Discomforts Participants may experience: * Emotional discomfort while discussing pain * Mild anxiety during interviews or questionnaires If needed, a psychiatrist on the research team will provide support or referrals. Potential Benefits * A better understanding of pain * Improved communication with care provider * Possible improvement in pain and jaw function Costs There are no costs to participate. All treatments are provided free of charge. Compensation / Treatment for Injury * If participants experience harm from this study, necessary medical care will be provided by the research team. * No financial compensation will be provided by King Abdulaziz University. Confidentiality Participants' identity and medical records will remain confidential. Only approved researchers and auditors will have access to data, in accordance with applicable laws. Any results published will not include participants' name or identifying details.