Pub Date : 2026-02-01Epub Date: 2025-12-21DOI: 10.1016/j.cct.2025.108200
Madeline R. Sterling , Michelle Shum , Ronica Peramsetty , Joselyne Aucapina , Faith Wiggins , Carmen Colon , Joanna Bryan Ringel , Ariel C. Avgar , Nicola Dell , Bibi N. Habib , Samprit Banerjee , Emma Tsui , Susan J. Andreae , Elissa Kozlov , Courtney Landis , Ian René Solano-Kamaiko , Monika M. Safford
Home health aides and attendants (HHAs) are a fast-growing healthcare workforce who are integral to the rising movement that allows older adults to age in place. However, HHAs themselves are a vulnerable group of caregivers. Mostly middle-aged women of color paid dismally low wages, HHAs' work is physically taxing, emotionally challenging, and socially isolating. Consequently, HHAs have high levels of depressive symptoms and stress. Prior studies suggest that HHAs want to address this, but do not know how and cannot access or afford traditional mental health services. Here we describe the protocol for a pilot randomized control trial (RCT) that aims to improve the mental health of HHAs through peer coaching (PC), an established and effective behavioral health intervention which has never been applied to HHAs or their workplace, the home environment. In collaboration with a labor and management fund of the largest healthcare union in the US (1199SEIU), we will conduct a single-site parallel arm pilot RCT with 100 HHAs to evaluate the feasibility, acceptability, and effectiveness of an adapted Living Healthy Program for HHAs delivered by PCs (intervention arm) vs. a general health promotion program (attention control arm). Primary effectiveness outcome will be a reduction in depressive symptoms; secondary effectiveness outcomes will be a reduction in stress and loneliness. This study offers a novel and potentially scalable way to improve the health of HHAs, an often overlooked, undervalued, but increasingly vital workforce that is needed to care for our rapidly aging population.
{"title":"iMprovIng the meNtal hEalth of home healTh AiDeS: A study protocol for the MINDSET study","authors":"Madeline R. Sterling , Michelle Shum , Ronica Peramsetty , Joselyne Aucapina , Faith Wiggins , Carmen Colon , Joanna Bryan Ringel , Ariel C. Avgar , Nicola Dell , Bibi N. Habib , Samprit Banerjee , Emma Tsui , Susan J. Andreae , Elissa Kozlov , Courtney Landis , Ian René Solano-Kamaiko , Monika M. Safford","doi":"10.1016/j.cct.2025.108200","DOIUrl":"10.1016/j.cct.2025.108200","url":null,"abstract":"<div><div>Home health aides and attendants (HHAs) are a fast-growing healthcare workforce who are integral to the rising movement that allows older adults to age in place. However, HHAs themselves are a vulnerable group of caregivers. Mostly middle-aged women of color paid dismally low wages, HHAs' work is physically taxing, emotionally challenging, and socially isolating. Consequently, HHAs have high levels of depressive symptoms and stress. Prior studies suggest that HHAs want to address this, but do not know how and cannot access or afford traditional mental health services. Here we describe the protocol for a pilot randomized control trial (RCT) that aims to improve the mental health of HHAs through peer coaching (PC), an established and effective behavioral health intervention which has never been applied to HHAs or their workplace, the home environment. In collaboration with a labor and management fund of the largest healthcare union in the US (1199SEIU), we will conduct a single-site parallel arm pilot RCT with 100 HHAs to evaluate the feasibility, acceptability, and effectiveness of an adapted <em>Living Healthy Program for HHAs</em> delivered by PCs (intervention arm) vs. a general health promotion program (attention control arm). Primary effectiveness outcome will be a reduction in depressive symptoms; secondary effectiveness outcomes will be a reduction in stress and loneliness. This study offers a novel and potentially scalable way to improve the health of HHAs, an often overlooked, undervalued, but increasingly vital workforce that is needed to care for our rapidly aging population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108200"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145818368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-16DOI: 10.1016/j.cct.2025.108191
Kerri N. Boutelle , Dawn M. Eichen , Michael Manzano , Noe C. Crespo , Ingrid Rivera-Iñiguez , Eduardo Castro , David R. Strong , Isabella Newell , Kristie Reed , Becky Marquez , Kyung E. Rhee
Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB.
{"title":"Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families","authors":"Kerri N. Boutelle , Dawn M. Eichen , Michael Manzano , Noe C. Crespo , Ingrid Rivera-Iñiguez , Eduardo Castro , David R. Strong , Isabella Newell , Kristie Reed , Becky Marquez , Kyung E. Rhee","doi":"10.1016/j.cct.2025.108191","DOIUrl":"10.1016/j.cct.2025.108191","url":null,"abstract":"<div><div>Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB.</div><div>Clinical trials # <span><span>NCT05437406</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108191"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-26DOI: 10.1016/j.cct.2025.108167
Terrence M. Riley , Camila Weschenfelder , Eric Ravussin , Jennifer C. Rood , Frank Greenway , Sarah Taff , Robert C. Hickner , Hongyuan Cao , Angelina R. Sutin , Gregory Todd , Stephen R. Hennigar , Claire E. Berryman
Background
Diet and exercise are the cornerstone of obesity prevention and treatment. However, a substantial number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Daily exposure to low-oxygen conditions may aid in current weight-loss strategies by increasing resting metabolic rate and decreasing appetite. Whether in-home, overnight, normobaric hypoxic exposure promotes body weight loss in adults with obesity remains unknown.
Methods
Fifty adults with obesity (BMI: 30–39.9 kg/m2) will complete this double-blind, parallel-arm, randomized, controlled-feeding clinical trial. Participants will be provided with a weight maintenance diet for 2 weeks while undergoing baseline measurements. Following the weight maintenance phase, an energy restricted diet (500 kcal/day below weight maintenance needs) will be provided in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% oxygen, elevation ∼2,640 m) or normoxia (8 h/night, 21% oxygen, elevation ∼60 m), using a commercially available, in-home tent system, for 8 weeks. The primary outcome is the difference in body weight change between interventions. Secondary outcomes include measures of body composition, total and resting energy expenditure, energy intake from an ad libitum meal, insulin sensitivity and glycemic control, sympathetic tone, iron absorption and indicators of iron status, stool microbial diversity and composition, appetite, psychosocial factors, and sleep quantity and quality.
Discussion
Chronic, overnight, low oxygen exposure may provide a novel intervention to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, and aid long-term weight management efforts in adults with obesity.
{"title":"Effects of daily low oxygen exposure on weight status, body composition, and metabolic health in adults with obesity: protocol for a randomized, double-blind, controlled-feeding study","authors":"Terrence M. Riley , Camila Weschenfelder , Eric Ravussin , Jennifer C. Rood , Frank Greenway , Sarah Taff , Robert C. Hickner , Hongyuan Cao , Angelina R. Sutin , Gregory Todd , Stephen R. Hennigar , Claire E. Berryman","doi":"10.1016/j.cct.2025.108167","DOIUrl":"10.1016/j.cct.2025.108167","url":null,"abstract":"<div><h3>Background</h3><div>Diet and exercise are the cornerstone of obesity prevention and treatment. However, a substantial number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Daily exposure to low-oxygen conditions may aid in current weight-loss strategies by increasing resting metabolic rate and decreasing appetite. Whether in-home, overnight, normobaric hypoxic exposure promotes body weight loss in adults with obesity remains unknown.</div></div><div><h3>Methods</h3><div>Fifty adults with obesity (BMI: 30–39.9 kg/m<sup>2</sup>) will complete this double-blind, parallel-arm, randomized, controlled-feeding clinical trial. Participants will be provided with a weight maintenance diet for 2 weeks while undergoing baseline measurements. Following the weight maintenance phase, an energy restricted diet (500 kcal/day below weight maintenance needs) will be provided in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% oxygen, elevation ∼2,640 m) or normoxia (8 h/night, 21% oxygen, elevation ∼60 m), using a commercially available, in-home tent system, for 8 weeks. The primary outcome is the difference in body weight change between interventions. Secondary outcomes include measures of body composition, total and resting energy expenditure, energy intake from an ad libitum meal, insulin sensitivity and glycemic control, sympathetic tone, iron absorption and indicators of iron status, stool microbial diversity and composition, appetite, psychosocial factors, and sleep quantity and quality.</div></div><div><h3>Discussion</h3><div>Chronic, overnight, low oxygen exposure may provide a novel intervention to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, and aid long-term weight management efforts in adults with obesity.</div></div><div><h3>Clinical trial registration</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05289310</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108167"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-26DOI: 10.1016/j.cct.2025.108168
Catherine E. Mosher , Eileen H. Shinn , Elizabeth L. Addington , Wei Wu , Jonathan B. Bricker , Paul R. Helft , Anita A. Turk , Laura B. Vater , Ashiq Masood , Shadia I. Jalal , Patrick J. Loehrer Sr. , Victoria L. Champion , Shelley A. Johns
Fatigue's interference with activities, mood, and cognition is one of the most prevalent and distressing problems of patients with advanced gastrointestinal cancer. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing demands. Evidence-based interventions for patient fatigue interference and caregiver burden are lacking in advanced gastrointestinal cancer. In a pilot trial, telephone-based Acceptance and Commitment Therapy (ACT) showed potential for reducing patient fatigue interference and caregiver burden in this population. The current Phase II trial seeks to determine the efficacy of this intervention for patients with advanced gastrointestinal cancer and moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 244 dyads are randomly assigned to either the ACT intervention or an education/support control. Participants in both conditions attend six weekly 50-min telephone sessions, four of which involve both dyad members, and a 30-min booster session. The primary aim is to test the effects of telephone-delivered ACT on patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. This trial also examines whether increased psychological flexibility, defined as mindful acceptance of present experiences, including challenges, while pursuing actions aligned with personal values, mediates ACT's effects on primary outcomes. Our ability to demonstrate ACT's efficacy will support its adoption in cancer care. Findings will also inform future ACT trials for dyads coping with other serious illnesses.
{"title":"Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer","authors":"Catherine E. Mosher , Eileen H. Shinn , Elizabeth L. Addington , Wei Wu , Jonathan B. Bricker , Paul R. Helft , Anita A. Turk , Laura B. Vater , Ashiq Masood , Shadia I. Jalal , Patrick J. Loehrer Sr. , Victoria L. Champion , Shelley A. Johns","doi":"10.1016/j.cct.2025.108168","DOIUrl":"10.1016/j.cct.2025.108168","url":null,"abstract":"<div><div>Fatigue's interference with activities, mood, and cognition is one of the most prevalent and distressing problems of patients with advanced gastrointestinal cancer. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing demands. Evidence-based interventions for patient fatigue interference and caregiver burden are lacking in advanced gastrointestinal cancer. In a pilot trial, telephone-based Acceptance and Commitment Therapy (ACT) showed potential for reducing patient fatigue interference and caregiver burden in this population. The current Phase II trial seeks to determine the efficacy of this intervention for patients with advanced gastrointestinal cancer and moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 244 dyads are randomly assigned to either the ACT intervention or an education/support control. Participants in both conditions attend six weekly 50-min telephone sessions, four of which involve both dyad members, and a 30-min booster session. The primary aim is to test the effects of telephone-delivered ACT on patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. This trial also examines whether increased psychological flexibility, defined as mindful acceptance of present experiences, including challenges, while pursuing actions aligned with personal values, mediates ACT's effects on primary outcomes. Our ability to demonstrate ACT's efficacy will support its adoption in cancer care. Findings will also inform future ACT trials for dyads coping with other serious illnesses.</div><div>Trial Registration ID: <span><span>NCT06532877</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108168"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-19DOI: 10.1016/j.cct.2025.108148
Christine A. Rabinak , Paul E. Kilgore , Mark A. Lumley , Sheila A.M. Rauch
Background
Prolonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ9-tetrahydrocannabinol (THC) enhances fear extinction and recall through brain cannabinoid receptor activation in fear processing.
Objective
Examine whether synthetic THC (dronabinol) augments PE effectiveness.
Design
Double-blind, placebo-controlled, trial with treatment-seeking PTSD patients (ages 18–60) randomized to 7.5 mg THC (n = 30) or placebo (n = 30). Randomization after sessions 1–2 (psychoeducation) ensures covariate-adaptive balance before the first medicated session. THC/placebo administered before PE sessions 3–6 of 10 total sessions so dosing coincided with extinction-learning sessions.
Setting
Wayne State University with remote PE delivery via Emory University.
Participants
Adults with PTSD (CAPS-5 ≥ 25) excluding for severe mental illness, substance use disorders, or contraindications to THC.
Interventions
PE therapy (10 sessions, up to 3 times / week) with THC or placebo administered 120 min before sessions to coincide with peak plasma levels.
Main outcomes
Primary: PTSD symptom severity (CAPS-5, PCL-5). Secondary: fMRI brain activation during fear extinction paradigms, skin conductance responses, and extinction retention measures pre/post-treatment.
Statistical analysis
Intent-to-treat linear mixed-effects models accounting for therapist clustering. Neuroimaging analyzed via region-of-interest and whole-brain approaches focusing on ventromedial prefrontal cortex, hippocampus, and amygdala.
Discussion
THC dosing and timing is based on prior mechanistic studies that demonstrated THC-related enhancement of extinction recall and frontolimbic circuit engagement. Aligning peak THC levels with exposure sessions maximizes potential for CB1-mediated augmentation of extinction learning. If effective, this FDA-approved augmentation strategy could be rapidly implemented to improve PE outcomes.
{"title":"Randomized trial of delta-9-tetrahydrocannabinol (THC) versus placebo to augment the effects of prolonged exposure therapy on fear extinction learning in post-traumatic stress disorder: Study rationale and protocol","authors":"Christine A. Rabinak , Paul E. Kilgore , Mark A. Lumley , Sheila A.M. Rauch","doi":"10.1016/j.cct.2025.108148","DOIUrl":"10.1016/j.cct.2025.108148","url":null,"abstract":"<div><h3>Background</h3><div>Prolonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ<sup>9</sup>-tetrahydrocannabinol (THC) enhances fear extinction and recall through brain cannabinoid receptor activation in fear processing.</div></div><div><h3>Objective</h3><div>Examine whether synthetic THC (dronabinol) augments PE effectiveness.</div></div><div><h3>Design</h3><div>Double-blind, placebo-controlled, trial with treatment-seeking PTSD patients (ages 18–60) randomized to 7.5 mg THC (<em>n</em> = 30) or placebo (n = 30). Randomization after sessions 1–2 (psychoeducation) ensures covariate-adaptive balance before the first medicated session. THC/placebo administered before PE sessions 3–6 of 10 total sessions so dosing coincided with extinction-learning sessions.</div></div><div><h3>Setting</h3><div>Wayne State University with remote PE delivery via Emory University.</div></div><div><h3>Participants</h3><div>Adults with PTSD (CAPS-5 ≥ 25) excluding for severe mental illness, substance use disorders, or contraindications to THC.</div></div><div><h3>Interventions</h3><div>PE therapy (10 sessions, up to 3 times / week) with THC or placebo administered 120 min before sessions to coincide with peak plasma levels.</div></div><div><h3>Main outcomes</h3><div>Primary: PTSD symptom severity (CAPS-5, PCL-5). Secondary: fMRI brain activation during fear extinction paradigms, skin conductance responses, and extinction retention measures pre/post-treatment.</div></div><div><h3>Statistical analysis</h3><div>Intent-to-treat linear mixed-effects models accounting for therapist clustering. Neuroimaging analyzed via region-of-interest and whole-brain approaches focusing on ventromedial prefrontal cortex, hippocampus, and amygdala.</div></div><div><h3>Discussion</h3><div>THC dosing and timing is based on prior mechanistic studies that demonstrated THC-related enhancement of extinction recall and frontolimbic circuit engagement. Aligning peak THC levels with exposure sessions maximizes potential for CB1-mediated augmentation of extinction learning. If effective, this FDA-approved augmentation strategy could be rapidly implemented to improve PE outcomes.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04080427</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108148"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-26DOI: 10.1016/j.cct.2025.108172
Erin E. Bonar , Jason E. Goldstick , Meredith L. Philyaw-Kotov , Carrie A. Bourque , Susan J. Woolford , Ken Resnicow , Joanna Quigley , Golfo Tzilos Wernette , Sana Ahmed , Debra M. Langlois , Maureen A. Walton
Prevention of alcohol use and misuse among adolescents is a public health priority. A health care visit provides an opportunity for screening for alcohol use and delivery of early interventions. Digital intervention delivery may reduce barriers to implementation in these settings. Herein, we describe the protocol from an ongoing comparative effectiveness study testing digital interventions to prevent escalation of alcohol use among adolescents (ages 12–19) connected to pediatric healthcare. Adolescents screening positive for past-year alcohol use are eligible to participate. Enrolled participants complete a baseline survey and are randomly assigned [stratified by sex and age group (12–14; 15–17; 18–19)] to an interactive, ∼45-min computerized brief intervention (CBI) alone or combined with 8 weeks of text messages. Outcomes are assessed at 3-, 6-, 9-, and 12-months post-baseline. Primary outcomes include past 3-month alcohol consumption. Secondary outcomes include alcohol and drug consequences, illicit and prescription drug misuse, and depression symptoms. In parallel, caregivers are also invited to participate, which involves referral to download the app “Talk. They Hear You.” and completing surveys at baseline, 3-, 6-, 9- and 12- months to report their use of the app. A novel aspect of this study is that we partnered with adolescents, caregivers, and health care staff and clinicians throughout the study to enhance relevance, effectiveness, and potential for future dissemination. This study will provide critical data to inform implementation of digital interventions for pediatric patients with the potential to prevent negative health outcomes and promote adolescent well-being.
{"title":"Comparison of digital behavioral interventions to prevent alcohol misuse among adolescents ages 12 to 19: A randomized clinical trial protocol","authors":"Erin E. Bonar , Jason E. Goldstick , Meredith L. Philyaw-Kotov , Carrie A. Bourque , Susan J. Woolford , Ken Resnicow , Joanna Quigley , Golfo Tzilos Wernette , Sana Ahmed , Debra M. Langlois , Maureen A. Walton","doi":"10.1016/j.cct.2025.108172","DOIUrl":"10.1016/j.cct.2025.108172","url":null,"abstract":"<div><div>Prevention of alcohol use and misuse among adolescents is a public health priority. A health care visit provides an opportunity for screening for alcohol use and delivery of early interventions. Digital intervention delivery may reduce barriers to implementation in these settings. Herein, we describe the protocol from an ongoing comparative effectiveness study testing digital interventions to prevent escalation of alcohol use among adolescents (ages 12–19) connected to pediatric healthcare. Adolescents screening positive for past-year alcohol use are eligible to participate. Enrolled participants complete a baseline survey and are randomly assigned [stratified by sex and age group (12–14; 15–17; 18–19)] to an interactive, ∼45-min computerized brief intervention (CBI) alone or combined with 8 weeks of text messages. Outcomes are assessed at 3-, 6-, 9-, and 12-months post-baseline. Primary outcomes include past 3-month alcohol consumption. Secondary outcomes include alcohol and drug consequences, illicit and prescription drug misuse, and depression symptoms. In parallel, caregivers are also invited to participate, which involves referral to download the app “Talk. They Hear You.” and completing surveys at baseline, 3-, 6-, 9- and 12- months to report their use of the app. A novel aspect of this study is that we partnered with adolescents, caregivers, and health care staff and clinicians throughout the study to enhance relevance, effectiveness, and potential for future dissemination. This study will provide critical data to inform implementation of digital interventions for pediatric patients with the potential to prevent negative health outcomes and promote adolescent well-being.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108172"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-12-04DOI: 10.1016/j.cct.2025.108176
Michelle R. Klawans , Olivia Kohrman , W. Braxton Jackson II , Chandra L. Jackson , Christine N. Metz , Ganesa Wegienka , Alison Motsinger-Reif , Anne Z. Steiner , Donna D. Baird , Dale P. Sandler , Anne Marie Z. Jukic
Background
While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cycles, and thus possibly improve fertility. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that vitamin D supplementation influences the hypothalamic-pituitary-ovarian axis.
Methods
This two-site RCT (NCT05050916) required participants to be aged 19–40 years old, having spontaneous menstrual cycles, and without certain chronic diseases or contraindications for vitamin D supplementation. At baseline participants provided information on their demographics and health history. Blood was drawn at the first clinic visit after which participants collected daily urine samples for one menstrual cycle (phase 1). Those with a 25-hydroxyvitamin D level less than 20 ng/ml (“low”) received cholecalciferol supplementation (randomized to either 4200 IU/week or 50,000 IU/week). A random sample of those without low vitamin D received placebo. Supplement (or placebo) was taken for three menstrual cycles which included collection of daily urine samples and home ovulation testing (phase 2). Participants collected self-administered vaginal and oral swabs and a subset collected menstrual effluent samples. Finally, participants kept a daily menstrual diary and weekly behavior diaries. The primary endpoints were mid-luteal progesterone, rate of estrogen rise, and pre-ovulatory luteinizing hormone.
Discussion
Findings from this RCT will provide insight into the relationship between vitamin D supplementation and menstrual cycle hormones. Vitamin D shows promise as a low-cost, non-hormonal intervention to regulate menstrual cycles.
{"title":"The Investigation of Vitamin D and Menstrual Cycles Trial (the inVitD Trial): A clinical trial of vitamin D supplementation on the hypothalamic-pituitary-ovarian axis","authors":"Michelle R. Klawans , Olivia Kohrman , W. Braxton Jackson II , Chandra L. Jackson , Christine N. Metz , Ganesa Wegienka , Alison Motsinger-Reif , Anne Z. Steiner , Donna D. Baird , Dale P. Sandler , Anne Marie Z. Jukic","doi":"10.1016/j.cct.2025.108176","DOIUrl":"10.1016/j.cct.2025.108176","url":null,"abstract":"<div><h3>Background</h3><div>While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cycles, and thus possibly improve fertility. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that vitamin D supplementation influences the hypothalamic-pituitary-ovarian axis.</div></div><div><h3>Methods</h3><div>This two-site RCT (<span><span>NCT05050916</span><svg><path></path></svg></span>) required participants to be aged 19–40 years old, having spontaneous menstrual cycles, and without certain chronic diseases or contraindications for vitamin D supplementation. At baseline participants provided information on their demographics and health history. Blood was drawn at the first clinic visit after which participants collected daily urine samples for one menstrual cycle (phase 1). Those with a 25-hydroxyvitamin D level less than 20 ng/ml (“low”) received cholecalciferol supplementation (randomized to either 4200 IU/week or 50,000 IU/week). A random sample of those without low vitamin D received placebo. Supplement (or placebo) was taken for three menstrual cycles which included collection of daily urine samples and home ovulation testing (phase 2). Participants collected self-administered vaginal and oral swabs and a subset collected menstrual effluent samples. Finally, participants kept a daily menstrual diary and weekly behavior diaries. The primary endpoints were mid-luteal progesterone, rate of estrogen rise, and pre-ovulatory luteinizing hormone.</div></div><div><h3>Discussion</h3><div>Findings from this RCT will provide insight into the relationship between vitamin D supplementation and menstrual cycle hormones. Vitamin D shows promise as a low-cost, non-hormonal intervention to regulate menstrual cycles.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108176"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-07DOI: 10.1016/j.cct.2025.108139
Elizabeth A. Jackson , Gustavo Aldama , Emily Spangler , Joshua Richman , Kamal Henderson , Gareth Dutton , Donald Dempsey , Alfredo Guzman , Jonathan Myers
Background
Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD exercise programs to Veterans is clinically important.
Methods
Veterans with documented PAD will be recruited from three sites (Birmingham, AL, Aurora, CO, and Palo Alto, CA) for a sequential multiple assignment randomized trial (SMART) comparing a web-based delivered walking program to a telehealth delivered walking program or usual care. After 12-weeks of the walking program, participants assigned to one of the walking program intervention arms who do not increase their maximal walking distance will be re-randomized to either receive both web-based and telehealth programs or continue their original assignment till week 24. Follow-up will continue for a third 12-weeks for a total duration of 36-weeks. A total of 225 Veterans will be recruited. The primary outcome of maximal walking distance will be assessed at baseline, 12, 24, and 36-weeks with a standardized treadmill protocol. Additional outcomes include pain-free walking distance and changes in health-related quality of life, measured at the same time points.
Conclusion
Determining the efficacy of delivering a home-based walking program can address barriers to facility-based programs which are often not available and create participant burden, particularly to those residing in rural areas distant from healthcare facilities. Veterans are both vulnerable to such barriers and overburdened by PAD. This study will contribute to current evidence related to home-based exercise interventions for Veterans with PAD.
{"title":"The telehealth vs. web-based delivered home-based walking for veterans with peripheral artery disease (TREK-PAD) trial","authors":"Elizabeth A. Jackson , Gustavo Aldama , Emily Spangler , Joshua Richman , Kamal Henderson , Gareth Dutton , Donald Dempsey , Alfredo Guzman , Jonathan Myers","doi":"10.1016/j.cct.2025.108139","DOIUrl":"10.1016/j.cct.2025.108139","url":null,"abstract":"<div><h3>Background</h3><div>Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD exercise programs to Veterans is clinically important.</div></div><div><h3>Methods</h3><div>Veterans with documented PAD will be recruited from three sites (Birmingham, AL, Aurora, CO, and Palo Alto, CA) for a sequential multiple assignment randomized trial (SMART) comparing a web-based delivered walking program to a telehealth delivered walking program or usual care. After 12-weeks of the walking program, participants assigned to one of the walking program intervention arms who do not increase their maximal walking distance will be re-randomized to either receive both web-based and telehealth programs or continue their original assignment till week 24. Follow-up will continue for a third 12-weeks for a total duration of 36-weeks. A total of 225 Veterans will be recruited. The primary outcome of maximal walking distance will be assessed at baseline, 12, 24, and 36-weeks with a standardized treadmill protocol. Additional outcomes include pain-free walking distance and changes in health-related quality of life, measured at the same time points.</div></div><div><h3>Conclusion</h3><div>Determining the efficacy of delivering a home-based walking program can address barriers to facility-based programs which are often not available and create participant burden, particularly to those residing in rural areas distant from healthcare facilities. Veterans are both vulnerable to such barriers and overburdened by PAD. This study will contribute to current evidence related to home-based exercise interventions for Veterans with PAD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108139"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145476673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-18DOI: 10.1016/j.cct.2025.108152
Jenna Hauben , Jacsen Luthy , Toluwaniose Nafiu , Alexis Brengartner , Mohamed Omar , Donya Nemati , Songzhu Zhao , Guy Brock , Kelly Urse , John Paro , Joshua J. Joseph
Background
Less than 15 % of individuals 65+ meet physical activity guidelines for aerobic and muscle-strengthening activities. Thus, in this study we will examine the feasibility and acceptability of utilizing smartwatches among Exercise is Medicine (EIM), a physician referral exercise program, for participants aged 65+ to improve physical activity.
Methods
We will conduct a single-arm trial. Participants will complete an 11-week exercise program combined with a smartwatch, monthly webinars, and two follow-up sessions at 6 and 12 months. Surveys will measure acceptability of the exercise program and the wearable smartwatch. The number of active participants, participant attendance and program completion rates will assess feasibility of the program.
Setting
Ambulatory care clinics affiliated with a medical center and community centers in Central Ohio.
Design
Single-arm pilot study.
Interventions
FASTER will consist of 3 one-on-one and 16 group sessions over 11 weeks in addition to wellness webinars and two follow-up one-on-one sessions 6 and 12 months after program completion. The one-on-one and group sessions will be led by an American College of Sports Medicine (ACSM) certified exercise physiologist with EIM credentials. All participants will receive a Fitbit smartwatch to use throughout the program.
Outcomes
The primary outcome is the feasibility and acceptability of FASTER. Secondary outcomes are change in physical activity, biometric measures, mental health, and quality of life.
Discussion
Incorporating wearable smartwatch technology into a physician referral exercise program may be a novel way to improve physical activity and health in older adults.
{"title":"Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals","authors":"Jenna Hauben , Jacsen Luthy , Toluwaniose Nafiu , Alexis Brengartner , Mohamed Omar , Donya Nemati , Songzhu Zhao , Guy Brock , Kelly Urse , John Paro , Joshua J. Joseph","doi":"10.1016/j.cct.2025.108152","DOIUrl":"10.1016/j.cct.2025.108152","url":null,"abstract":"<div><h3>Background</h3><div>Less than 15 % of individuals 65+ meet physical activity guidelines for aerobic and muscle-strengthening activities. Thus, in this study we will examine the feasibility and acceptability of utilizing smartwatches among Exercise is Medicine (EIM), a physician referral exercise program, for participants aged 65+ to improve physical activity.</div></div><div><h3>Methods</h3><div>We will conduct a single-arm trial. Participants will complete an 11-week exercise program combined with a smartwatch, monthly webinars, and two follow-up sessions at 6 and 12 months. Surveys will measure acceptability of the exercise program and the wearable smartwatch. The number of active participants, participant attendance and program completion rates will assess feasibility of the program.</div></div><div><h3>Setting</h3><div>Ambulatory care clinics affiliated with a medical center and community centers in Central Ohio.</div></div><div><h3>Design</h3><div>Single-arm pilot study.</div></div><div><h3>Interventions</h3><div>FASTER will consist of 3 one-on-one and 16 group sessions over 11 weeks in addition to wellness webinars and two follow-up one-on-one sessions 6 and 12 months after program completion. The one-on-one and group sessions will be led by an American College of Sports Medicine (ACSM) certified exercise physiologist with EIM credentials. All participants will receive a Fitbit smartwatch to use throughout the program.</div></div><div><h3>Outcomes</h3><div>The primary outcome is the feasibility and acceptability of FASTER. Secondary outcomes are change in physical activity, biometric measures, mental health, and quality of life.</div></div><div><h3>Discussion</h3><div>Incorporating wearable smartwatch technology into a physician referral exercise program may be a novel way to improve physical activity and health in older adults.</div><div>Clinical Trial Registration Number: <span><span>NCT06287255</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108152"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145563109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-24DOI: 10.1016/j.cct.2025.108162
Sarah Medley , Marianthie Wank , Roy N. Tamura , Thomas M. Braun , Kelley M. Kidwell
Effective care for chronic conditions with high rates of non-response or relapse requires personalized and adaptive treatment guidelines known as dynamic treatment regimens (DTRs). Sequential, multiple assignment, randomized trials (SMARTs) are the gold standard for estimating DTRs, but SMARTs, like any trial, may struggle with recruitment and retention due to patient treatment preferences. A partially randomized, patient preference SMART (PRPP-SMART) design overcomes these issues by assigning participants with a preference to their preferred treatment and randomizing indifferent participants at each stage of the SMART. The PRPP-SMART design and methods were motivated in part by STAR*D (NCT00021528), which produced second- and third-line treatment recommendations for patients with major depressive disorder (MDD) who tend to have comorbidities, prior treatment history, and treatment preferences. Traditional, randomized clinical trials typically fail to recruit generalizable study populations, and traditional methods are not appropriate to combine data from randomized and non-randomized participants. We have previously shown that weighted and replicated regression models (WRRMs) combining data from all participants in a PRPP-SMART estimate DTR effects given binary outcomes with minimal bias. Here, we evaluate WRRMs to estimate PRPP-SMART DTRs with continuous outcomes and find that the performance of our method is robust to different preference rates and outcome distributions. We illustrate our method using data adapted from STAR*D which considered preferences in treatment assignment but did not compare DTRs. The PRPP-SMART design and methods presented here would have overcome many shortcomings of STAR*D and establish a framework for meaningful DTR estimates in future pragmatic SMARTs.
{"title":"SMARTs with treatment preference: Pragmatic SMART design and methods motivated by STAR*D","authors":"Sarah Medley , Marianthie Wank , Roy N. Tamura , Thomas M. Braun , Kelley M. Kidwell","doi":"10.1016/j.cct.2025.108162","DOIUrl":"10.1016/j.cct.2025.108162","url":null,"abstract":"<div><div>Effective care for chronic conditions with high rates of non-response or relapse requires personalized and adaptive treatment guidelines known as dynamic treatment regimens (DTRs). Sequential, multiple assignment, randomized trials (SMARTs) are the gold standard for estimating DTRs, but SMARTs, like any trial, may struggle with recruitment and retention due to patient treatment preferences. A partially randomized, patient preference SMART (PRPP-SMART) design overcomes these issues by assigning participants with a preference to their preferred treatment and randomizing indifferent participants at each stage of the SMART. The PRPP-SMART design and methods were motivated in part by STAR*D (NCT00021528), which produced second- and third-line treatment recommendations for patients with major depressive disorder (MDD) who tend to have comorbidities, prior treatment history, and treatment preferences. Traditional, randomized clinical trials typically fail to recruit generalizable study populations, and traditional methods are not appropriate to combine data from randomized and non-randomized participants. We have previously shown that weighted and replicated regression models (WRRMs) combining data from all participants in a PRPP-SMART estimate DTR effects given binary outcomes with minimal bias. Here, we evaluate WRRMs to estimate PRPP-SMART DTRs with continuous outcomes and find that the performance of our method is robust to different preference rates and outcome distributions. We illustrate our method using data adapted from STAR*D which considered preferences in treatment assignment but did not compare DTRs. The PRPP-SMART design and methods presented here would have overcome many shortcomings of STAR*D and establish a framework for meaningful DTR estimates in future pragmatic SMARTs.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108162"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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