Contemporary Clinical Trials Communications最新文献

{"title":"Operating characteristics of unequal allocation ratios in platform trials with the staggered addition of drugs using binary endpoints","authors":"Yosuke Shimizu ,&nbsp;Ryoichi Hanazawa ,&nbsp;Hiroyuki Sato ,&nbsp;Akihiro Hirakawa","doi":"10.1016/j.conctc.2025.101450","DOIUrl":"10.1016/j.conctc.2025.101450","url":null,"abstract":"<div><h3>Background</h3><div>One recommendation for the allocation ratio between multiple drugs and a shared placebo control group in platform trials (PTs) is to use a <span><math><mrow><msqrt><mi>k</mi></msqrt></mrow></math></span>:1 allocation ratio for the placebo group relative to the drug group, where <span><math><mrow><mi>k</mi></mrow></math></span> is the number of drug groups with ongoing patient enrollment during the trials. However, the practical utility of such unequal allocation ratios in PTs lacks adequate study.</div></div><div><h3>Methods</h3><div>We compared the performances of equal and unequal allocation ratios through simulations to imitate practical PTs using only concurrent controls and binary endpoints for hospitalized patients with infectious diseases. The operating characteristics, including the type I error rate, power of hypothesis testing, and total sample size, were evaluated.</div></div><div><h3>Results</h3><div>In PTs, using an unequal allocation ratio (i) results in a considerable augmentation of the total sample size and prolongs the study duration when monthly patient enrollment is low, but (ii) the target power of hypothesis testing is often preserved compared to an equal allocation ratio, even when we incorrectly specify the drug and placebo group mortality rates assumed in the sample size calculation. The average power increase using an unequal allocation ratio relative to the equal allocation ratio per 100-patient increase in the placebo group was approximately 1.9 % in the selected scenarios of our simulation studies.</div></div><div><h3>Conclusion</h3><div>The results of the current study highlight the quantitative advantages and disadvantages of using unequal allocation ratios in PTs using only concurrent controls under the specific conditions assumed in our simulations and analyses.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101450"},"PeriodicalIF":1.4,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143445622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Participant recruitment and retention in randomised controlled trials of melanoma surveillance: A scoping review","authors":"Deonna M. Ackermann ,&nbsp;Karen Bracken ,&nbsp;Jolyn K. Hersch ,&nbsp;Monika Janda ,&nbsp;Robin M. Turner ,&nbsp;Katy J.L. Bell","doi":"10.1016/j.conctc.2025.101461","DOIUrl":"10.1016/j.conctc.2025.101461","url":null,"abstract":"<div><h3>Background</h3><div>This scoping review aims to collate and describe data on recruitment, retention, and strategies used to improve these, in randomised controlled trials of melanoma surveillance.</div></div><div><h3>Methods</h3><div>We searched MEDLINE, EMBASE, CINAHL and CENTRAL databases from inception until October 23, 2023. Two reviewers screened titles and abstracts, and full-texts, and one reviewer extracted data (convenience sample (n = 5) checked by a second). Eligibility criteria included: (i) RCT design, (ii) clinical setting, (iii) participants at increased risk of melanoma, (iv) interventions for early melanoma detection, and (v) early detection outcomes or surrogates such as improved skin self-examination. We calculated summary statistics and undertook qualitative data synthesis.</div></div><div><h3>Results</h3><div>From 1746 records, 21 trials (reported in 28 papers) were included. Recruitment sources included dermatology clinics, general practice sites, and hospital databases or registries. Trials reported proportions of those screened who were eligible (mean 75 %, range 24–100 %), proportions of those eligible who were randomised (mean 63 %, range 24–95 %), numbers randomised per month (mean 25 participants, range 2–74), and proportion of those randomised who completed outcome measurements (mean 85 %, range 59–100 %) for self-report questionnaires at primary timepoints). Recruitment strategies included targeted participant identification and flexible consent processes. Retention strategies included setting narrow eligibility criteria, reminders, and financial incentives. Reporting on strategies was limited and there were no reports on effectiveness. Few studies reported recruiter facing initiatives or public and patient involvement.</div></div><div><h3>Discussion</h3><div>More consistent and detailed reporting of recruitment and retention strategies in RCTs is needed, alongside evaluations of their effectiveness.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101461"},"PeriodicalIF":1.4,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention","authors":"Carrington CJ. Shepherd ,&nbsp;Melissa A. Dunham ,&nbsp;Lina Gubhaju ,&nbsp;Karen E. Lamb ,&nbsp;Digsu N. Koye ,&nbsp;Phoebe Fitzpatrick ,&nbsp;Emily Banks ,&nbsp;Kaarin J. Anstey ,&nbsp;Melinda Carrington ,&nbsp;Daniel McAullay ,&nbsp;Ofra Kalter-Leibovici ,&nbsp;Grace Joshy ,&nbsp;Lesley Nelson ,&nbsp;Jason Agostino ,&nbsp;Ellie Paige ,&nbsp;Kathleen Abu-Saad ,&nbsp;Elise Alexander ,&nbsp;Rona MacNiven ,&nbsp;Kelsey Griffen ,&nbsp;Fiona Collins ,&nbsp;Sandra Eades","doi":"10.1016/j.conctc.2025.101457","DOIUrl":"10.1016/j.conctc.2025.101457","url":null,"abstract":"<div><h3>Background</h3><div>Limited available data indicate that dementia prevalence rates among Aboriginal and Torres Strait Islander (hereafter Aboriginal) peoples are 3–5 times higher than the overall Australian population. Effective, pragmatic and scalable interventions are urgently required to address this disproportionate burden of dementia in Aboriginal populations.</div></div><div><h3>Methods</h3><div>Kaat Koort is a pragmatic two-arm parallel-group randomized controlled trial which will recruit a sample of 354 participants from two Aboriginal community-controlled health services in the south-west of Western Australia. Eligible participants are aged 35–60 years with risk factors for cardiovascular disease. Participants will be randomized in a 1:1 ratio to receive either a 12-month multifactorial lifestyle intervention (guided by Aboriginal Health Practitioners) that involves cardiovascular risk management, a lifestyle program targeting diet and physical activity, and support for smoking cessation and depression, or usual care (control). The primary endpoints are change in (i) systolic, and (ii) diastolic blood pressure. Secondary endpoints are changes in other cardiovascular risk factors (elevated blood pressure, HDL cholesterol, HbA1c, waist circumference, and absolute cardiovascular risk score), cognitive functioning, and adherence to Australian dietary and physical activity guidelines. Outcomes will be collected at baseline, and 6- and 12-months post-baseline.</div></div><div><h3>Discussion</h3><div>This trial aims to determine the efficacy of a multifactorial lifestyle intervention in reducing blood pressure among Aboriginal people aged 35–60 years at risk of dementia.</div></div><div><h3>Trial registration number</h3><div>ACTRN12621001022853; Australian New Zealand Clinical Trial Registry identifier.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101457"},"PeriodicalIF":1.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial","authors":"He Chen ,&nbsp;Sixing Liu ,&nbsp;Shuai Gao ,&nbsp;Jiamin Yi ,&nbsp;Hangyu Shi ,&nbsp;Jiufei Fang ,&nbsp;Weiming Wang ,&nbsp;Huan Chen ,&nbsp;Zhishun Liu","doi":"10.1016/j.conctc.2025.101454","DOIUrl":"10.1016/j.conctc.2025.101454","url":null,"abstract":"<div><h3>Background</h3><div>Senile pruritus (SP), characterized by idiopathic itch in individuals aged 60 years and older without primary skin lesions, significantly impacts sleep and quality of life. Effective alternative treatments are needed. Acupuncture has been suggested as a potential intervention to alleviate pruritus; however, its role in managing SP remains uncertain. This study aims to evaluate the efficacy and safety of acupuncture for SP.</div></div><div><h3>Methods</h3><div>This single-center, parallel, two-arm, randomized, sham-controlled trial will enroll 200 patients diagnosed with SP in a 1:1 ratio to either the acupuncture or sham acupuncture group, receiving acupuncture or sham acupuncture three sessions weekly for six weeks. Participants, outcome assessors, and the statisticians will be blinded. The primary outcome is the change from baseline in the Average Pruritus Numerical Rating Scale (AP-NRS) score at week 6. Secondary outcomes include changes in AP-NRS (at other timepoints), Peak Pruritus Numerical Rating Scale (PP-NRS), number of scratch episodes, itchy area of body surface, overall dry skin score (ODS), the Dermatology Life Quality Index (DLQI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and Patient Global Impression of Change (PGIC). Long-term effects of acupuncture will also be explored. Adverse events and additional treatments will be monitored throughout the study period. The modified intention-to-treat (mITT) population which includes participants who complete baseline assessments and receive at least one treatment session will be analyzed.</div></div><div><h3>Discussion</h3><div>This trial represents the first rigorously designed, single-center, randomized, sham-controlled study assessing the effects and safety of acupuncture for senile pruritus. We used valid outcome measurements which can provide valuable insights into the patient's symptoms and facilitate tracking symptoms over time and evaluate treatment effectiveness. This study may provide valuable insights into the research topic and inform future research.</div></div><div><h3>Ethics and dissemination</h3><div>This study has received ethical approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2024-087-KY).</div></div><div><h3>Trial registration</h3><div>Registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT06506240) on July 11, 2024.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101454"},"PeriodicalIF":1.4,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of an evidence-based telehealth-delivered weight-loss intervention to expand reach and enhance access to underserved groups after stroke","authors":"Evan Elizabeth McShan ,&nbsp;Shahad Alrawi ,&nbsp;Stephanie Calhoun ,&nbsp;Taylor Gilliland ,&nbsp;Monica Bennett ,&nbsp;Rosemary Dubiel ,&nbsp;Simon Driver","doi":"10.1016/j.conctc.2025.101458","DOIUrl":"10.1016/j.conctc.2025.101458","url":null,"abstract":"<div><div>Obesity is a risk factor for stroke, and survivors of stroke have a high rate of obesity and greater burden of obesity-related chronic conditions (e.g., heart disease, hypertension, re-occurring stroke) compared to the general population. Despite the health disparity, there is a lack of evidence-based weight-loss interventions tailored to individuals post stroke, as most health promotion programs exclude this population. Our team's work modifying and examining the efficacy of a modified version of the Diabetes Prevention Program Group Lifestyle Balance for people post stroke (GLB-CVA) is promising with results from an in-person randomized controlled trial (RCT) showing significant weight-loss (10.1 ± 16.8 lbs. [4.88 %]) and improvements in waist circumference, diastolic blood pressure, pain, social participation, eating practices, and health habits at 12-months post intervention. To expand the reach and accessibility of the GLB-CVA intervention, we will complete a RCT to assess the efficacy of telehealth delivery by enrolling 94 participants post stroke over a 3-year period. Results may provide an evidence-based, scalable telehealth weight-loss program designed for people post stroke that clinicians and community workers can use to increase accessibility to underserved groups.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101458"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143438057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing the impact of foot and hand reflexology on anxiety and physiological indices in colonoscopy candidates: A randomized clinical trial","authors":"Mohamad Golitaleb ,&nbsp;Ali Safdari ,&nbsp;Fatemeh Rafiei ,&nbsp;Ameneh Yaghoobzadeh ,&nbsp;Najmeh Mohamadi ,&nbsp;Razieh Mokhtari","doi":"10.1016/j.conctc.2025.101449","DOIUrl":"10.1016/j.conctc.2025.101449","url":null,"abstract":"<div><h3>Introduction and objective</h3><div>Colonoscopy is a standard diagnostic procedure, yet pre-procedural anxiety remains a prevalent concern. While pharmacological interventions are available, non-pharmacological approaches such as reflexology offer a promising alternative. Despite its therapeutic potential, comparative evidence on foot and hand reflexology in this setting is limited. This study aimed to evaluate their effects on pre-colonoscopy anxiety and physiological parameters.</div></div><div><h3>Methods</h3><div>This randomized clinical study was conducted from November 2022 to August 2023 at the Amir al-Momenin Educational and Therapeutic Center in Arak, Iran. A total of 105 patients were randomly assigned to three equal-sized groups (n = 35) using block randomization: foot reflexology, hand reflexology, and a control group. Patients in the intervention groups received a 30-min reflexology session. Anxiety levels were assessed using the Spielberger State-Trait Anxiety Inventory (STAI-Y1), a validated tool for measuring situational anxiety. Physiological indices, including systolic and diastolic blood pressure, heart rate, and arterial oxygen saturation (SpO2), were measured immediately before and after the intervention.</div></div><div><h3>Results</h3><div>There were no significant differences in clinical outcomes among the groups at baseline (p &gt; 0.05). However, following the intervention, the mean anxiety scores in both reflexology groups (foot reflexology: 44.39 ± 5.21; hand reflexology: 45.6 ± 4.49) were significantly lower than that of the control group (48.05 ± 4.81) (p = 0.008), as determined by one-way analysis of variance (ANOVA). The anxiety reduction was more pronounced in the foot reflexology group than the hand reflexology group, although this difference did not reach statistical significance (p &gt; 0.05). Additionally, post-intervention assessments revealed significant differences in systolic blood pressure (foot reflexology: 123.48 ± 16.40 mmHg; hand reflexology: 122.65 ± 14.97 mmHg; control group: 132.14 ± 18.48 mmHg) and heart rate (foot reflexology: 78.60 ± 9.54 bpm; hand reflexology: 78.25 ± 11.41 bpm; control group: 85.05 ± 10.82 bpm) across the groups (p &lt; 0.05). However, no significant differences were observed for diastolic blood pressure or arterial oxygen saturation (SPO2) between groups (p &gt; 0.05).</div></div><div><h3>Conclusion</h3><div>The findings of this study indicate that reflexology, particularly foot reflexology, can significantly reduce anxiety and lead to improvements in physiological parameters, such as systolic blood pressure and heart rate, in patients undergoing colonoscopy. These results highlight the potential of reflexology as an effective complementary method for managing anxiety and enhancing patient comfort during medical procedures.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101449"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395391","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of a parent-based treatment for children and adolescents with obsessive-compulsive disorder: Protocol of a multiple baseline, single-case experimental design study","authors":"Julia D.K. Veeger ,&nbsp;Luuk Stapersma ,&nbsp;Eli R. Lebowitz ,&nbsp;Bonne Zijlstra ,&nbsp;Ramón Lindauer ,&nbsp;Elisabeth M.W.J. Utens ,&nbsp;Chaim Huijser","doi":"10.1016/j.conctc.2025.101456","DOIUrl":"10.1016/j.conctc.2025.101456","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric obsessive-compulsive disorder (OCD) is a severely impairing disorder, associated with high levels of family accommodation (FA). Approximately 40 % of youth do not benefit from first-line treatment options (cognitive behavioral therapy or pharmacotherapy). Supportive Parenting for Anxious Childhood Emotions (SPACE) is a parent-based treatment, teaching parents to reduce FA and increase supportive parenting, thereby aiming to improve the child's OCD. This article presents the protocol of a multiple baseline single-case experimental design (SCED) study to test the efficacy of SPACE in reducing OCD severity and FA in youth with OCD.</div></div><div><h3>Methods</h3><div>This SCED consists of a baseline, treatment, and follow-up phase. In total 25 youth (7–18 years) with OCD, who previously received cognitive behavioral therapy (CBT) unsuccessfully, aborted treatment early, or were not able to receive CBT due to too high levels of OCD/anxiety, and their parents will be included. They will be randomly allocated to one of three baseline phase options (4, 6 or 8 weeks). The treatment phase consists of 12 weekly sessions of SPACE with parents. Throughout all phases, OCD severity and FA will be briefly assessed thrice a week. Standard clinical measurements assessing OCD severity and FA and secondary parameters will be conducted at six timepoints, till 6 months follow-up.</div></div><div><h3>Conclusion</h3><div>Combining the innovative SPACE treatment with a SCED provides detailed insight into the relationship between OCD and FA over time. Studying this in clinical practice in complex cases that are normally understudied, helps to improve more personalized care for youth with OCD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101456"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A photo-narrative intervention protocol for clinicians and parents of children with severe neurological impairment in the PICU","authors":"Jori Bogetz ,&nbsp;Elsa Ayala ,&nbsp;Jordan Anderson ,&nbsp;Liz Morris ,&nbsp;Krysta S. Barton ,&nbsp;Miranda C. Bradford ,&nbsp;Chuan Zhou ,&nbsp;Joyce Yi-Frazier ,&nbsp;R. Scott Watson ,&nbsp;Abby R. Rosenberg","doi":"10.1016/j.conctc.2025.101455","DOIUrl":"10.1016/j.conctc.2025.101455","url":null,"abstract":"<div><h3>Background</h3><div>Children with severe neurological impairment (SNI) have central nervous system conditions that result in medical complexity and lifelong caregiver assistance. When children with SNI are admitted to the pediatric intensive care unit (PICU), their parents/families may experience elevated stress due to poor communication with clinicians.</div></div><div><h3>Methods</h3><div>To address this, we created a photo-narrative intervention designed to facilitate parent-clinician communication. The intervention asks parents/families to share 3 photos with captions that inform clinicians about their child's well-being and quality-of-life. The steps include: 1) learning about photo-narratives; 2) deciding on a story; 3) selecting photos; and 4) identifying the broader context. Clinicians receive a companion guide on how to use the photo-narrative. In this pilot randomized controlled trial, N = 40 parent/family caregivers of children with SNI and their child's PICU clinicians will be randomized to receive the photo-narrative intervention or usual care. Participants will complete study surveys at enrollment and the child's PICU discharge; intervention-arm participants will also complete semi-structured interviews at discharge. The primary aim is to describe: 1) feasibility, assessed by the recruitment (approached/enrolled) and completion (intervention completion/intervention-arm) rates; and 2) acceptability (recommend the intervention/intervention-arm). We also will evaluate proof of concept by comparing changes in parent self-reported stress, perceptions of therapeutic alliance, and effects on stigma, resilience, benefit-finding, and respect as well as clinician self-reported empathy and perspective-taking.</div></div><div><h3>Discussion</h3><div>This study will evaluate the feasibility and acceptability of a novel photo-narrative intervention designed to improve caregiver stress and communication. Findings will guide the development of future multisite studies.</div></div><div><h3>Clinical trial registration</h3><div>NCT06208332.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101455"},"PeriodicalIF":1.4,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143422259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adapting MOVED as a web-based moral elevation intervention for veterans with PTSD: Using feedback from a pilot trial and subject matter experts","authors":"Adam P. McGuire ,&nbsp;Alexander Riera ,&nbsp;Xrystyan Lascano","doi":"10.1016/j.conctc.2025.101445","DOIUrl":"10.1016/j.conctc.2025.101445","url":null,"abstract":"<div><h3>Background</h3><div>Alternative, easily accessible treatment options are needed to aid efforts to address the negative effects of PTSD among veterans. One approach that has shown promise in a pilot trial is a moral elevation-based intervention titled, MOVED. Qualitative feedback from veterans in the pilot trial identified several strengths, but also highlighted opportunities to improve the intervention. In this adaptation phase, we incorporated feedback from pilot participants with input from subject matter experts (SMEs) to inform adaptation decisions using the Model for Adaptation Design and Impact (MADI) framework. In this paper, we outline the process and final adaptations decisions in preparation for a future efficacy trial to assess the impact of MOVED on targeted outcomes for veterans with PTSD.</div></div><div><h3>Method</h3><div>We identified 10 SMEs that included veterans, clinicians, and researchers who participated in workgroup meetings to review 17 identified issues from the pilot and potential adaptations to address those concerns. We used the MADI framework to guide workgroup meeting discussions to determine what changes should be incorporated, including identifying potential negative outcomes for any adaptations and if they can be mitigated with other actions.</div></div><div><h3>Results</h3><div>SMEs agreed with proposed adaptations for 15 of 17 issues and proposed mitigating measures for four of those adaptations to avoid anticipated negative outcomes. Two proposed solutions were refuted and not selected for adaptation.</div></div><div><h3>Conclusions</h3><div>Using the MADI framework with input from SMEs allowed us to make informed decisions about adaptations for MOVED, thus contributing to further treatment development in preparation for a future efficacy trial.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101445"},"PeriodicalIF":1.4,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143378966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"UNIPDES - An internet-based transdiagnostic intervention for college students’ psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol","authors":"Ömer Özer ,&nbsp;Gizem Öztemür ,&nbsp;Ali Ercan Altinöz ,&nbsp;Burak Köksal ,&nbsp;Uğur Doğan ,&nbsp;Sedat Batmaz ,&nbsp;Recep Gür ,&nbsp;Ahmet Altinok","doi":"10.1016/j.conctc.2025.101443","DOIUrl":"10.1016/j.conctc.2025.101443","url":null,"abstract":"<div><div>University students often face significant mental health challenges, including depression, anxiety, and difficulties in adjustment, which can be exaggerated by the demands of independent living and increased life responsibilities. These challenges are often compounded by barriers to seeking help, such as stigma and limited access to university resources, which can further deteriorate students' well-being. This protocol was created to assist college students in overcoming these obstacles and to assess, in comparison to a control group, the impact of a guided and unguided online intervention platform based on transdiagnostic CBT (UNIPDES) on depression, anxiety, and adjustment levels. The calculated sample size for the study will include 330 students, and the participants will be selected from five different universities located in Türkiye. Participants will be randomly assigned to either guided, unguided, or control groups. Guided and unguided group participants will receive six weeks of intervention, and the waitlist control group will receive the unguided version of the program after twelve weeks of randomization. Assessments will take place at baseline, post-test (8 weeks post-baseline) and follow-up (12 weeks post-baseline). A Mixed ANOVA will be employed to analyze the data, with Group (Guided, Unguided, Control) as the between-subjects factor and Time (Baseline, Post-Test, Follow-Up) as the within-subjects factor, as well as to assess the interaction effect between Group and Time on the primary outcomes—changes in depression, anxiety, and adjustment levels. Additionally, students’ reasons for dropout will be assessed qualitatively. The results from this study can build evidence for the effectiveness of transdiagnostic guided and unguided internet-based intervention for treating depression, anxiety, and adjustment problems of students. UNIPDES can provide a flexible, easy-to-access, and cost-effective treatment for the problems that students commonly face. Trial registration is registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Protocol Registration and Results System (Trial number: NCT06245200).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101443"},"PeriodicalIF":1.4,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143395389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}