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Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial
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University of Washington
Diverticulitis
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a
pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical
management for patients with quality of life (QoL) limiting diverticular disease. A parallel... expand
The COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is a pragmatic, patient-level randomized superiority trial of elective colectomy vs. best medical management for patients with quality of life (QoL) limiting diverticular disease. A parallel observational cohort will include those who are disinclined to have their treatment choice randomized, but are willing to contribute information about their outcomes. The goal of the COSMID trial is to answer the question: For patients with QoL-limiting diverticular disease, is elective colectomy more effective than best medical management? The hypothesis being tested in the COSMID trial is that patient-reported outcomes (PROs) among patients in the surgery arm will be superior to those in the best medical management arm. Type: Interventional Start Date: Oct 2019 |
A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active...
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Biogen
Lupus Erythematosus, Systemic
The primary objective of this study is to demonstrate efficacy of BIIB059 (litifilimab)
compared with placebo in participants with active systemic lupus erythematosus (SLE), who are
receiving background lupus standard of care (SOC) therapy in reducing disease activity.
The... expand
The primary objective of this study is to demonstrate efficacy of BIIB059 (litifilimab) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. The secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid(s) (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE and to evaluate immunogenicity of BIIB059 in participants with active SLE. Type: Interventional Start Date: Jul 2021 |
Metformin in Alzheimer's Dementia Prevention
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Columbia University
Mild Cognitive Impairment
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting
metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early
and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55
years... expand
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 18 months and have 4 visits: baseline, 6-months, 12-months, and 18-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 18. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT. The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary clinical outcome will be changes in the Alzheimer's Disease Cooperative Study Preclinical Alzheimer's Cognitive Composite. Secondary subclinical outcomes will be changes in cortical thickness AD signature areas, changes in white matter hyperintensity volume, changes in brain amyloid burden, changes in brain tau burden, and changes in plasma biomarkers of amyloid, tau, and neurodegeneration. The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono. Type: Interventional Start Date: Mar 2021 |
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety...
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Boston University Charles River Campus
Anxiety Disorders
Cardiovascular Diseases
Anxiety
Health Behavior
The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an
unmet need for those with cardiovascular disease (CVD), given that patients with CVD
experience numerous barriers for in-person treatment engagement. The research plan for the
proposed... expand
The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control). Type: Interventional Start Date: Feb 2022 |
Facilitation of Extinction Retention and Reconsolidation Blockade in PTSD
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Boston University
Post Traumatic Stress Disorder
Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD).
Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly
across individuals and PTSD subpopulations. Neurobiological factors impacted by life
experiences,... expand
Purpose: About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genetics can affect treatment responses. These factors can alter brain capacities needed to reprocess traumatic memories prevent them from triggering intensely distressing, disruptive, out-of-place responses. For example, during psychotherapy for PTSD, trauma memory activation engages two competing brain processes that affect recovery: "extinction" versus "reconsolidation" of trauma-related emotional, physiological, and behavioral responses. This study tests whether a single intravenous (IV) dose of allopregnanolone (Allo) compared to placebo (which is non-active): 1. promotes consolidation of extinction learning (sub-study 1) or 2. blocks reconsolidation physiological responses triggered by aversive memories (sub-study 2). The study also tests whether Allo compared to placebo affects retention of non-aversive memories. Type: Interventional Start Date: Mar 2022 |
Couples Lived Experience
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NYU Langone Health
Alzheimer Disease
Dementia of Alzheimer Type
This is a longitudinal study with regular quantitative assessments of all participants every
six months for 3 years. The quantitative portion of the study will recruit couples,
consisting of individuals over the age of 65 who are in a committed relationship. Both
members of... expand
This is a longitudinal study with regular quantitative assessments of all participants every six months for 3 years. The quantitative portion of the study will recruit couples, consisting of individuals over the age of 65 who are in a committed relationship. Both members of the couple must be willing to participate at baseline. The assessment is in two parts. In the first part, each member of the couple will be asked the following: demographic information, mental health history, self-reported physical and emotional health, measures of emotional and mental health, personality, relationship and attachment style, social support and self-efficacy. Then each member of the study couple will be asked a series of questions to determine whether they consider themselves a caregiver. If they do, individuals will be asked to respond to additional caregiver questionnaires. Follow-ups will occur every six months for the study couples for a total of three years from the baseline visit. Each visit, the entire assessment except for demographic questions, will be re-administered to each individual in the couple. At the end of each questionnaire battery, individuals will be screened for cognitive impairment and those who are in the middle to advanced stages of dementia will no longer participate. Recruitment will end when 600 individuals (300 couples,150 couples at each site) are enrolled in the longitudinal portion of the study. All study visits will be conducted virtually via Zoom or WebEx video conferencing. Analyses will be conducted to determine the association between changes in dyadic relationship and changes in mental health and cognitive outcomes, to elucidate how relationship characteristics impact health and well-being as perceived by each member of the dyad. Type: Observational Start Date: Apr 2021 |
CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy
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University of Texas at Austin
Obsessive-Compulsive Disorder
Post Traumatic Stress Disorder
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a
significant public health problem. This study is designed to evaluate the predictive power of
a novel biomarker based on a CO2 challenge, thus addressing the central question "can this
easy-to-administer... expand
Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?" Type: Interventional Start Date: Nov 2022 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
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Eisai Inc.
Preclinical Alzheimer's Disease
Early Preclinical Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite
5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with
lecanemab... expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). Type: Interventional Start Date: Jul 2020 |
Neuroimaging Sleep and Mood in Depression
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Boston University Charles River Campus
Major Depression
This study will investigate how sleep and mood are related in patients with depression and in
healthy controls. It will use MRI-based measures of brain function to determine how neural
systems are modulated by sleep and sleep deprivation, and its links to mood in depression.... expand
This study will investigate how sleep and mood are related in patients with depression and in healthy controls. It will use MRI-based measures of brain function to determine how neural systems are modulated by sleep and sleep deprivation, and its links to mood in depression. Type: Interventional Start Date: Jan 2022 |
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
Johns Hopkins University
Atrial Fibrillation
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE
design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct
Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing
Smart... expand
REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk. Type: Interventional Start Date: Jul 2023 |
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib,...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.
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The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. Type: Interventional Start Date: Mar 2023 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in
combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination
with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with
pomalidomide... expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed...
Merck Sharp & Dohme LLC
Carcinoma, Non-Small-Cell Lung
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in
combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab
versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage... expand
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants. Type: Interventional Start Date: May 2022 |
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Janssen Research & Development, LLC
Amyloidosis
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide,
Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd
treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light... expand
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2). Type: Interventional Start Date: Mar 2022 |
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension...
Inventiva Pharma
NASH - Nonalcoholic Steatohepatitis
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3
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This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3 Type: Interventional Start Date: Aug 2021 |
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with
pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Type: Interventional Start Date: Aug 2020 |
A Cluster Randomized Trial of the H2GO! Program
Boston University
Childhood Obesity
This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls
Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting
sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week
intervention... expand
This proposal involves a collaboration with the Massachusetts Alliance of Boys and Girls Clubs. The goal is to evaluate the efficacy of youth empowerment intervention targeting sugar-sweetened beverage consumption on childhood obesity among youth. The 12-session 6-week intervention consists of health and narrative sessions and youth-led activities. For this cluster randomized controlled trial [RCT} at 10 sites, the investigators will recruit 45 parent-child pairs per site for a total of 450 parent-child pairs. The primary outcome is child participants' body mass index (BMI) z scores. Secondary outcomes include children's sugar-sweetened beverage intake, water intake, and youth empowerment. Change in outcomes over time among participants in the intervention sites will be compared to change in outcomes over time among participants Type: Interventional Start Date: Oct 2020 |
Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)
Gladwin, Mark, MD
Sickle Cell Disease
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel
two-arm study aimed to determine if automated exchange blood transfusion and standard of care
administered to high mortality risk adult SCD patients reduces the total number of episodes... expand
The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care. Type: Interventional Start Date: Feb 2020 |
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced...
Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D)
of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2
combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to... expand
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D). Type: Interventional Start Date: Sep 2019 |
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
United Therapeutics
PAH
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Hypertension
Connective Tissue Diseases
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
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Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH. Type: Interventional Start Date: Aug 2018 |
mTBI Identification and Monitoring Through Retinal Scanning
Rebiscan, Inc.
Brain Injuries, Traumatic
Rebion has developed a device, the Rebion trauma tool (referred to as the head and
intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a
binocular retinal scan. Preliminary data obtained from hospitalized patients with a
clinically-confirmed... expand
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls. Type: Observational Start Date: Aug 2023 |
A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes
Tandem Diabetes Care, Inc.
Type 2 Diabetes Treated With Insulin
A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ
technology in adults with type 2 diabetes using basal-bolus insulin therapy.
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A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ technology in adults with type 2 diabetes using basal-bolus insulin therapy. Type: Interventional Start Date: Jun 2023 |
Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression
Albert Einstein College of Medicine
Diabetes
Type 1 Diabetes
This project will evaluate a telemedicine-delivered, Unified Protocol for
Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review
to target anxiety and depressive symptoms and glycemic control in young adults with type 1
diabetes.
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This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in young adults with type 1 diabetes. Type: Interventional Start Date: Oct 2023 |
Alcohol and "Heat of the Moment" Sexual Decision Making
Boston University Charles River Campus
Alcohol Drinking
Sex, Unsafe
Hiv
HIV transmission remains a significant public health concern, especially among men who have
sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of
transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how
contextual... expand
HIV transmission remains a significant public health concern, especially among men who have sex with men (MSM). Condomless anal intercourse (CAI) continues to be the major route of transmission for MSM. Thus, to reduce the incidence of HIV, it is critical to identify how contextual risk factors influence CAI and develop behavioral strategies that modify risk factors directly or reduce their influence on behavior. This study will examine the mechanisms through which one of the central contextual risk factors, heavy drinking, influences sexual decision processes in the natural environment and test the benefit of a brief intervention designed to reduce sexual risk behavior among those who engage in heavy drinking. Type: Interventional Start Date: Nov 2023 |
Feasibility of Remote Tai Chi
Boston University
PTSD
Pain, Chronic
In the proposed trial, the investigators plan to refine interventions, then conduct a small
randomized trial to provide critical information to inform a future large-scale randomized
efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain.
Building... expand
In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Building on the combined experience the proposed study will progress in new directions to: 1. Adapt, refine, and standardize two 12-week treatment protocols (Tai Chi and a Wellness control condition) for Veterans diagnosed with PTSD and chronic musculoskeletal pain during Phase One. Tai Chi and Wellness interventions will be adapted for delivery via a videoconferencing platform for the population and piloted in a 'dry run'. 2. Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two. 3. Utilize information from this trial to plan and design a large randomized control study evaluating the efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic musculoskeletal pain. Type: Interventional Start Date: Jun 2023 |