Treatment Trials

258 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Well-being in Students and Teachers Study
Description

The goal of this randomized trial is to test the effectiveness of two universal classroom-based mindfulness social and emotional learning (SEL) programs (one for students and one for teachers) by examining behavioral outcomes on 5th and 6th grade students and their teachers. The main questions it aims to answer are: * What are the singular and combined effects of a mindfulness-based SEL education programs for teachers and their students on the development of students' and their teachers' social, emotional, and cognitive competence, and well-being? * Can mindfulness-based SEL education programs for students and teachers foster the creation of caring, inclusive, equitable, and collaborative classroom contexts? * Can mindfulness-based SEL education programs support the development of students' and teachers' prosocial attitudes, mindsets that positively impact student learning? * Are the effects durable beyond the end of the programs with regard to the singular and combined mindfulness-based SEL interventions? A total of 24 classrooms will be randomized into one of three study conditions: 1. Mindfulness SEL program for Educators only 2. Mindfulness SEL program for Educators and Mindfulness SEL program for Students in combination, and 3. "Business as usual" (comparison groups in which regular classroom SEL curricula is implemented). Data will be obtained via multiple objective and subjective methods (e.g., self- and teacher-reports, peer behavioral assessments) from different sources (e.g., self-, peer-, and teacher-reports). Data will also be collected to monitor implementation of the two programs. To explore the ways in which these two programs impact student, teacher, and classroom outcomes, data will be analyzed to compare students and teachers in the three conditions. In Phase One (year one), the investigators will conduct an experimental "outcome" study to examine the singular and combined effects of the two programs by comparing pre-test and post-test measures across the three conditions. In Phase Two (year two), the investigators will conduct a six-month follow up with those teachers and students who participated in Phase One in order to determine the degree to which the program effects are durable after the program has ended.

RECRUITING
A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
Description

The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.

ENROLLING_BY_INVITATION
Research and Engagement on Substance Use: Harnessing Awareness and Personalized Education (RESHAPE) to Improve Well-being and Self-efficacy
Description

The goal of this study is to gather feedback on a potential program that collects and shares real-world information to help create products and services to support people who have substance use disorders.

COMPLETED
Self-efficacy for Interprofessional Experiential Learning Through an International Service Trip
Description

This pilot mixed-methods educational study examines the impact of interprofessional experiential learning on self-efficacy during a service trip to Guatemala. Methods: Fourteen participants were recruited from occupational therapy, physical therapy, and speech pathology students at a university. They engaged in a 9-day international interprofessional learning service trip and completed pre- and post-surveys with open-ended questions to measure and reflect on the impact of service trips on self-efficacy.

Conditions
ENROLLING_BY_INVITATION
Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability
Description

EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.

RECRUITING
Self-efficacy-based Auditory Rehabilitation with Over-the-Counter Hearing Aids
Description

This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids. The main questions it aims to answer are: * Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids? * Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids. Participants will: * Visit for one appointment to complete a few questionnaires without OTC hearing aids * Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences * Visit for a second appointment to complete the same questionnaires with OTC hearing aids.

RECRUITING
Assessing the Efficacy of Self-Driven Repetitive Artmaking Practice
Description

The primary purpose of this study is to assess the acceptability of self-directed art making for people with chronic pain and OUD/opioid misuse, or to state it another way, whether people with chronic pain and OUD/opioid misuse will realistically do this artistic practice on their own. A secondary question of this study is to explore whether doing this art practice can help minimize pain during the artistic process, lessen depression and anxiety, and improve feelings of social connection.

ACTIVE_NOT_RECRUITING
Feasibility of a Self-Efficacy Ecological Momentary Intervention (EMA) App
Description

This "SeApp" study aims to test a self-efficacy Ecological Momentary Intervention (EMI) in healthy students in the context of COVID-19. EMIs are mostly smartphone-based applications that deliver interventions to people while being engaged in their daily life activities. The app harnesses the power of self-efficacy autobiographical memories (e.g. problem-solving memories, memories of success). Ecological Momentary Assessments (EMAs) are also incorporated into the study to capture individuals' feelings, affect, and behavior in real time.

Conditions
RECRUITING
Virtual Reality as a Self-Efficacy Intervention
Description

The goal is to explore the use of Virtual Reality (VR) as an intervention to increase self-efficacy in a healthcare setting. The investigators would like to determine if an educational VR intervention in the course of healthcare could increase pediatric patient self-efficacy compared to standard of care (i.e no VR).

Conditions
COMPLETED
A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy
Description

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy (primary outcome).

Conditions
UNKNOWN
Does Self-efficacy Predict Outcomes Among U.S. Military Academy Cadets During Initial Entry Training?
Description

Background: Lower back injuries are a common occurrence in athletes, sports programs, and in the military (Bengtsson, 2018; Lovalekar, 2021). The Army's new fitness test includes a three-repetition maximum deadlift, and this inclusion has raised concern amongst servicemembers and healthcare workers due to the association between deadlifts and lower back injuries. There is debate amongst researchers about the role of deadlift form in lower back injury prevention, specifically related to flexion of the spine (Sjoberg, 2020). Purpose: The purpose of this study is to investigate the effect of low back pain education (either cautionary regarding injury risk or reassuring regarding spine resiliency) on deadlift performance (weight lifted), and if this education has an effect on self-efficacy and perceived spine vulnerability. Participants: Participants will be incoming new cadets at the United States Military Academy (USMA). Inclusion criteria are cadets age 17-26 (cadets under the age of 18 are legally emancipated therefore able to consent), those participating in the ACFT, and speak and understand English. Study Design: This study will be a randomized controlled trial with parallel design and 1:1 allocation ratio. The investigators plan to use cluster randomization. There will be three groups- control, cautionary, reassuring (Jackson, 2005). The investigators are also planning a prospective cohort study to assess self-efficacy, injury, and performance over time. Procedures: Data will be collected at the United States Military Academy during the summer of 2022 during cadet basic training. Shortly after new cadets arrive at USMA, the investigators will gather demographic and initial self-efficacy information. The randomized control element of this study will occur before and during the maximum deadlift (MDL) of the Army Combat Fitness Test (ACFT). At the start of cadet basic training, investigators will randomly allocate each company of cadets into one of three groups (three companies per group.) The investigator will administer the education (cautionary, reassuring, or control) shortly prior to cadets taking the MDL, and will collect results after the ACFT. The cautionary education is similar to standard information provided to many servicemembers before the start of an ACFT or a maximum deadlift.

RECRUITING
Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes
Description

The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety

TERMINATED
Breast Cancer Self-Efficacy Scale for Partners
Description

The concept of self-efficacy is a major predictor of physical, psychological, social and overall quality of life (QoL) among breast cancer survivors (BCS). Because survivor and partner outcomes are often linked, it is reasonable to hypothesize that self-efficacy is an important predictor of physical, psychological, social and overall QoL in partners as well. However, this hypothesis has yet to be tested, in part because no scale exists to measure cancer-related self-efficacy in partners. Development and psychometric testing of such a scale is a critical first step in developing a theoretical model predicting QoL in this population. Partners of BCS often report lower QoL compared to partners of healthy women, making them an important focus of research. During the award period, the applicant will follow standard instrument development procedures to develop the Breast Cancer Self-Efficacy Scale for Partners (BCSES-P) and test the scale's psychometric properties using a large and diverse sample of partners of breast cancer survivors.

Conditions
COMPLETED
The Effect of a Non-Operating Room Anesthesia (NORA) Safety Video on Clinician Anxiety and Perceived Self-Efficacy
Description

The purpose of this study is to assess the effect of a non-operating room anesthesia (NORA) safety video on clinician anxiety and perceived self-efficacy.

COMPLETED
Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts
Description

The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 16-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge (or gum, based on preference) on quit date (week 4), consistent with recommended guidelines based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge (or gum, based on preference), initiated on quit date. The investigators will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. The investigators will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8, 12, and 16.

COMPLETED
A Smartphone-Based Approach to Improved Breast-Feeding Rates And Self-Efficacy
Description

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy.

Conditions
COMPLETED
Effect of Digital Health Coaching Program on Self-efficacy and Patient Reported Outcomes of Patients With Newly Diagnosed Acute Myeloid Leukemia or Chronic Lymphocytic Leukemia
Description

This trial studies the effect of a digital health coaching program on self-efficacy and patient reported outcomes of patients with acute myeloid leukemia or chronic lymphocytic leukemia that is newly diagnosed. A digital health coaching program may help leukemia patients report information about their health while receiving treatment, which may lead to improvement in overall health.

COMPLETED
Happy, Healthy, Loved: A Mobile-delivered Breastfeeding Self-efficacy Intervention for First Time Parents
Description

The purpose of this study is to test if a mobile device delivered intervention program can improve breast-feeding self-efficacy in primiparous mothers.

Conditions
COMPLETED
Improving Self-Efficacy Through a Telenovela: Feasibility Study
Description

In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during weekly hospice visits to prepare caregivers for proper use of hospice support and healthcare services

Conditions
UNKNOWN
Brain Injury Self-Efficacy Scale Validation
Description

The purpose of this study is to validate the Brain Injury Self-Efficacy Scale as a measure of self-efficacy in brain injury by comparing it with other measures of self-efficacy, the GSE, and PROMIS self-efficacy.

TERMINATED
Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy
Description

Chronic stroke is the leading cause of long-term disability in the United States. Post-stroke health is negatively impacted by two interrelated factors-a substantial risk of falls and limited walking activity. The risk of falling is a barrier to walking activity, with falls self-efficacy mediating the relationship between impaired physical capacity and limited activity. The ability to recover from a fall (i.e. arrest a fall before impact) is a logical, yet untested rehabilitation target to enable walking activity through sustained benefits to falls self-efficacy. Our aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. Five participants will undergo an adapted version of fall-recovery training. We will gather evidence of the implementation, adaptation, and limited efficacy of this intervention in affecting falls self-efficacy and walking activity.

Conditions
TERMINATED
Massage Therapy for Self-efficacy in LVAD Recipients
Description

This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device. In addition to usual care, half of the volunteer patients will receive a massage at regular clinic visits and half will not receive any massage.

Conditions
COMPLETED
A Video Chat Intervention for Enhancing Self-efficacy for Lifestyle Physical Activity
Description

The purpose of this study is to evaluate the efficacy of three, brief (10-minute) theory-guided video chats for increasing self-efficacy for lifestyle physical activity versus a time-matched video chat comparison group designed to increase self-efficacy for work-life balance. Participants will include individuals who are low-active, full-time (\>35 hours/week) working adults.

COMPLETED
Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU
Description

This is a Phase 3 open-label extension study enrolling adult patients with PKU who were previously treated with pegvaliase in Studies PAL-003 (NCT00924703) or 165-302 (NCT02468570). The study is designed to evaluate the long-term safety and efficacy of pegvaliase administered at doses \> 40 mg/day to 60 mg/day.

COMPLETED
Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training
Description

This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.

COMPLETED
Self-efficacy, Beliefs and Adherence- Pilot and Feasibility Trial of a Pharmacist-led Intervention
Description

This study uses an intervention mixed methods design. The overall purpose is to improve medication adherence and assess the clinical impact on diabetes outcomes among patients with uncontrolled diabetes. We will examine if usual care combined with a clinic-based health literacy/psychosocial support intervention improves medication adherence compared to usual care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial Veterans Hospital in Madison, targeting individuals with uncontrolled diabetes. The patient-centered health literacy intervention will focus on enhancing patients' self-efficacy and addressing patients' negative beliefs in medicine and illness.

COMPLETED
Effects of an OT Workstation Intervention on Knowledge, Self-efficacy, and Habit Formation
Description

The study aims to determine whether a face to face ergonomic workstation intervention has any advantage over an online instructional training program for acquisition of knowledge, self-efficacy, and habit formation.

COMPLETED
SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain
Description

The overall goal of the project is to reduce pain-related, 30-day readmission rates for sickle cell disease (SCD) patients. The investigators want to see if a mobile phone application (app) can help decrease the need for repeat admission to the hospital because of sickle cell pain.

ACTIVE_NOT_RECRUITING
Identifying Barriers and Strategies to Support Self-efficacy for Medication Adherence With Text Messaging
Description

The investigators will explore barriers to improving self-efficacy, or the ability to feel in control of their disease, and medication adherence with text messaging through surveys and interviews with adolescents and adults with SCD cared for at the Vanderbilt Meharry Center of Excellence (VMCE) in Sickle Cell Disease (SCD). The investigators will identify preferences to improve and sustain adherence to daily medication through selection of investigator-proposed or patient-generated text messaging strategies. Finally, the investigators will fill in the literature gaps by describing barriers to self-efficacy and medication adherence among adults with SCD as well as adolescents with SCD who are transitioning to adult care.

COMPLETED
Laughter Therapy Effects on Mood, Stress and Self-efficacy in People With Neurological Diseases.
Description

This is a prospective investigation of the effects of Laughter therapy (LT) on perceived stress, self-efficacy, mood and other wellness measures in people with the following neurological conditions: Alzheimer's disease, amyotrophic lateral sclerosis, brain injury, Huntington's Disease, multiple sclerosis, Parkinson's Disease, post-stroke, spinal cord injury.