Treatment Trials

429 Clinical Trials for Various Conditions

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COMPLETED
Targeted Literature Review and Subject Interviews in Wiskott-Aldrich Syndrome (WAS)
Description

WAS is a rare primary immune deficiency disease caused by genetic mutation and is more common in males than females. The purpose of this study is to understand experiences of WAS subjects and caregivers to identify important concepts of interest that could be measured in future Phase IIIb trials. This is a qualitative cross-sectional study that will include a sample of approximately, 8 subjects with WAS and 13 caregivers of subjects with a diagnosis of WAS in the United States, United Kingdom and France. A 60 to 90 minute open-ended interview will be conducted over the telephone or video conference that will be audio-recorded for subsequent transcription. The aim of these interviews is to obtain subject and caregiver perspectives on the impact of WAS and its associated treatments on quality of life and experiences of living with WAS.

ACTIVE_NOT_RECRUITING
Motivational Interviewing for Physical Activity
Description

The goal of this behavioral research study is to learn why some African American (AA) women choose not to exercise often and to learn if teaching African American women how to support the exercise habits of a partner will increase their physical activity and help them to stay more active over time. The primary goal of the proposed intervention is: Aim 1: To conduct formative research using semi-structured in-depth interviews and focus groups with sedentary AA women to investigate the role and importance of social support for PA; Aim 2: To determine the feasibility of recruiting and implementing "Culturally Appropriate Physical Activity Motivational Interviewing" (CAPMI) intervention in sedentary AA women; Aim 3: To pilot test and evaluate the efficacy of the CAPMI in increasing PA, social support, self-efficacy and reducing barriers to Physical Activity (PA) at post-intervention compared to an attention control group.

Conditions
NOT_YET_RECRUITING
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Description

Background: A Timeline Follow-Back (TLFB) is a tool that helps researchers track how much of a substance a person uses. Different versions of the tool are used to track the use of alcohol, cigarettes, and cannabis. But there is no TLFB to track a person s use of nonmedical opioids. (These are opioids not obtained from a medical source; they may also be called "street" opioids.) Researchers are creating an Opioid TLFB (OpiTLFB) that asks better questions and records more useful answers to identify what kinds of nonmedical opioids people are using. Objective: To test a new research tool to track a person's use of nonmedical opioids. Eligibility: People aged 18 years or older who used a nonmedical opioid within the past 30 days. Design: Participants will have 1 study visit at a clinic in Baltimore, Maryland. The visit will take 1 to 4 hours. Participants will sit at a computer with a researcher and fill out a calendar. They will record their use of opioids each day for the past 30 days. They will be asked what the drugs were called and what they looked like. This task might take 30 minutes. Participants will be interviewed. The researcher will ask about their experiences getting opioids from friends, dealers, or other sources; how the experience of getting opioids has changed over time; and about any changes they have noticed across different areas of Baltimore. Researchers will ask how the OpiTLFB could be easier to fill out and how it could provide more useful information. This task might take 30 minutes. Participants will provide a urine sample.

COMPLETED
Computer-Mediated Versus Face-to-Face Motivational-Type Interviews
Description

This study looks at whether in-person and computer-based motivational type interviews lead to the same kind of language and behavior change in young adults when they talk about their marijuana use. Researchers compared how much participants talked about wanting to change their level of marijuana use (change talk) or maintain their level of marijuana use (sustain talk) during each type of interview. Researchers investigated if change talk and sustain talk predicted who continued to use or not use marijuana. All participants completed: * A survey assessing their frequency of marijuana use. * A brief motivational type interview, either a face-to-face-motivational type interview or computer-mediated motivational type interview. * A two-month follow-up survey, again assessing their level of marijuana use.

Conditions
RECRUITING
OTAGO Exercise Program and Motivational Interviewing
Description

The goal of this study is to see if OTAGO instructors, who have been trained in a special communication method called motivational interviewing, can help older adults start and stick with the OTAGO exercise program. The results will help guide future research on how behavior change techniques can support other fall prevention strategies.

RECRUITING
DMD Voice: Qualitative Interviews With Patients and Caregivers
Description

The purpose of this study is to understand DMD functional losses or abilities and their association with independence and quality of life from the perspective of individuals with DMD and/or and their caregivers. This is a qualitative interview study in which individuals with DMD and/or their caregivers will be asked to participate in a semi-structured, approximately 60- minute interview. Interviews will focus on functional abilities and independence. Caregivers and boys with DMD will be interviewed. This study includes no treatment nor intervention; however, some participants are being treated by a drug that is approved in the U.S. and the U.K. and under investigation in other geographies.

RECRUITING
Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose
Description

A hybrid type 1 study will be conducted to evaluate efficacy and preliminary implementation considerations for a novel intervention to promote uptake of drug checking services (DCS) and safer drug use behaviors among people who use drugs (PWUD) to reduce incidence of overdose (OD) and HIV and Hepatitis C virus (HCV) infections in San Diego County. Along with \~50 other syringe services programs (SSPs) in the US, the Harm Reduction Coalition San Diego (HRCSD), a local SSP, recently launched CheckSD (San Diego), a DCS using test strips (TS) and Fourier Transform Infrared Spectrometry (FTIR) that allows people to submit drug samples with non-nominal identifiers and obtain personalized results. While most existing DCS using FTIR offer some counseling, no theory-based interventions to increase DCS uptake and promote post-DCS adoption of safer drug use behaviors have been rigorously evaluated

Conditions
NOT_YET_RECRUITING
Development and Preliminary Testing of a "Papageno"-Story Interview Intervention- Aim 3
Description

The purpose of this study is to determine the effects of a short "Papageno story" video of a compilation of interviews on proximal risk factors for suicide. The researchers believe that the intervention may increase protective factors related to suicide.

RECRUITING
Overdose Recovery and Care Access (ORCA) Qualitative Stakeholder Interviews and County-level Data
Description

The study is a quasi-experimental investigation of a sub-acute stabilization center (SASC) for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes. Seattle Fire EMS will assess, refer, and arrange transport for participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours. A continuous process improvement (CPI) approach will monitor and refine the intervention. Characterization of the interventions will be based upon analysis of service utilization patterns over time along with interviews and surveys with stakeholders.

NOT_YET_RECRUITING
Technology Assisted Motivational Interviewing
Description

Building on our successful pilot work to develop a Motivational Interviewing (MI)-capable chatbot and cessation coach, the investigators propose to address the problems of intrinsic motivation and social barriers to smoking cessation by evaluating a highly scalable and easily accessible digital-coaching intervention that 1) promotes readiness to change using a technology-assisted MI (TAMI) chatbot, 2) provides compelling and accessible multilingual education about smoking cessation tools, and 3) develops a tailored quit plan addressing social barriers to treatment initiation and sustainment.

NOT_YET_RECRUITING
AI-Augmented Motivational Interviewing Training for Primary Care
Description

This study will examine the impact of training primary care providers (PCPs) in motivational interviewing (MI) using artificial intelligence (AI) to augment the training process. MI is a patient-centered approach to engaging patients in their own care. There will be a control group and two intervention groups, with the intervention groups receiving a different amount of MI training. The hypothesis is that the AI-augmented MI training will result in improved patient outcomes, improved clinician wellbeing, and reduced behavioral manifestation of clinician biases. This mixed-methods project will also collect qualitative data from structured interviews and focus groups with participating PCPs to examine perceived facilitators and barriers to the use of the MI approach in primary care.

COMPLETED
Feasibility, Acceptability, and Fidelity of Motivational Interviewing to Increase Maternal NICU Presence
Description

Maternal presence in the NICU during an infant's hospitalization is critical for the infant's medical recovery and overall neurodevelopmental trajectory. However, despite the importance of maternal presence in these settings, the current literature shows that families are often absent at bedside. To date, no behavioral interventions have been conducted to promote increased maternal visitation patterns in NICU settings. This project will aim to fill this gap in the literature by conducting a pilot study that uses a motivational interviewing intervention with the aim of increasing maternal visitation rates to a level IV NICU.

RECRUITING
A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting
Description

The investigators are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. The investigators are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills.

RECRUITING
Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City
Description

This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management.

Conditions
RECRUITING
Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews
Description

This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.

RECRUITING
Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
Description

This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).

ENROLLING_BY_INVITATION
A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth
Description

The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs. Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group).

TERMINATED
Motivational Interviewing for Stroke
Description

Motivational interviewing (MI) is a style of communication designed to elicit a person's own reasons for change to drive commitment toward a goal. The goal of this study is to assess the effect of trainee-led MI on patients diagnosed with acute stroke or TIA attributable to modifiable risk factors in comparison to conventional post-stroke counseling, based on patient outcomes, and meaning of work and sense of fulfillment for trainees.

RECRUITING
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
Description

Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to \<2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - \<2 years).

Conditions
COMPLETED
Zenyth: Motivational Interviewing-based Telehealth Intervention for Bacterial Sexually Transmitted Infection Screening
Description

In the United States (US), gay and bisexual men living with human immunodeficiency virus (HIV) bear a heavy burden of bacterial sexually transmitted infections (STIs) such as gonorrhea, chlamydia, and syphilis. It is important to diagnose and treat STIs in a timely manner to prevent health complications and reduce transmissions. The purpose of this study is to understand whether gay and bisexual men living with HIV are willing to collect and return specimens for bacterial STI testing when combined with live audio/video (AV) conferencing support.

ENROLLING_BY_INVITATION
Motivational Interviewing for Vaccine Uptake in Latinx Adults
Description

The goal of this clinical trial is to test whether modified behavioral health services, integrating motivational interviewing, will reduce vaccine hesitancy and increase uptake for the COVID-19 and influenza vaccines among Latinx adults with mental illness.

RECRUITING
Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement
Description

The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.

COMPLETED
Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination
Description

The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.

ENROLLING_BY_INVITATION
Metacognitive Self Control and Job Interview Training
Description

The study is a randomized controlled trial (RCT) that assesses the effectiveness of a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality job interview training (VR-JIT) in a sample of formerly incarcerated individuals. The study also includes an implementation evaluation.

COMPLETED
Expressive Interviewing Agents to Support Health-Related Behavior Change
Description

Expressive writing and motivational interviewing are well-known approaches to help patients handle stressful life events. While these methods are often applied by human counselors, it is less well understood if an automated approach can encourage behavior changes in patients. This study presents an automated writing system and evaluates its impact on individual behavior related to the COVID-19 pandemic. The investigators developed a rule-based dialogue system for "Expressive Interviewing" to elicit writing from participants on the subject of how COVID-19 has impacted their lives. In May-June 2021, the investigators randomly assigned online participants (N=151) to the Expressive Interviewing task and a control condition. The investigators examined their behavior with a survey before the intervention, immediately after, and two weeks after. In aggregate, task participants experienced a significant decrease in stress in the short-term (\~23% decrease, p \< 0.001) and no significant changes in longer-term outcomes compared to the control group. Within the task, participants showed different outcomes based on their writing. Participants who wrote with more anxiety-related words showed a greater short-term decrease in stress (R=-0.264, p\<0.001), and those who wrote with more positive emotion words reported a more meaningful experience (R=0.243, p=0.001). For longer-term effects, participants who wrote with more lexical diversity underwent an increase in social activity (R=0.266, p\<0.001). Expressive Interviewing can generally help with mental health in the short term but not longer-term, and participants' writing choices may make a difference in outcomes. While there were no significant long-term effects observed, the positive short term effect points to potential future directions with a series of Expressive Interviewing interventions for longer-term effects.

Conditions
WITHDRAWN
Improving Relationships Using Motivational Interviewing
Description

This research aims to optimize patient-clinician relationships through motivational interviewing training in a Federally Qualified Health Center (FQHC) to improve health outcomes for African American patients with Type 2 diabetes.

COMPLETED
Qualitative Interviews With Healthcare Professionals
Description

PLANNING PHASE- Qualitative interviews with Healthcare Professionals to assist in the development of a new Patient Reported Outcome Measure (PROM) to assess patient's emotional wellbeing, and perceptions of Total Knee Replacement (TKR) surgery for the treatment of knee arthritis.

RECRUITING
Interview Study of Adult and Child Patients and Parents of Children with Swelling Due to Nephrotic Syndrome.
Description

Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome. Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.

RECRUITING
Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment
Description

This K23 study is an effectiveness-implementation hybrid type I design to determine the effectiveness of Motivational Interviewing at Intake (MII), relative to intake-as-usual on client engagement and mechanisms of engagement among adults seeking outpatient addiction treatment. We also will obtain personnel feedback on the feasibility of implementing MII into standard practice by having personnel from the addiction treatment study sites complete implementation climate measures before Motivational Interviewing (MI) training and post-clinical trial, as well as an individual interview on implementation feasibility post-trial.

COMPLETED
ClientBot: a Conversational Agent That Supports Skills Practice and Feedback for Motivational Interviewing
Description

This multi-stage study includes qualitative interviews, usability research, and a randomized training study of technology implementation in a real-world clinical setting. The proposed study will enhance and evaluate an artificial intelligence (AI) based, conversational agent (ClientBot) that simulates a realistic client with alcohol concerns and provides performance-based feedback to support counselor training. The research is in collaboration with PRI, which focuses on training alcohol and substance use counselors.