scholarly journals Lock to Live—An Interactive Web-Based Lethal Means Safety Decision Aid for Suicidal Adults: Pilot Randomized Controlled Trial

10.2196/16253 ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. e16253 ◽  
Author(s):  
Marian E Betz ◽  
Christopher E Knoepke ◽  
Scott Simpson ◽  
Bonnie J Siry ◽  
Ashley Clement ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Suicide Prevention ◽  
Decision Aid ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Web Based ◽  
Randomized Controlled ◽  
Lethal Means ◽  
Pilot Randomized Controlled Trial

Background Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based Lock to Live (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. Objective This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). Methods At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. Results Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. Conclusions The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. Trial Registration ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501

scholarly journals An Interactive Web-Based Lethal Means Safety Decision Aid for Suicidal Adults (Lock to Live): Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Marian E Betz ◽  
Christopher E Knoepke ◽  
Scott Simpson ◽  
Bonnie J Siry ◽  
Ashley Clement ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Suicide Prevention ◽  
Decision Aid ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Web Based ◽  
Randomized Controlled ◽  
Lethal Means ◽  
Pilot Randomized Controlled Trial

BACKGROUND Counseling to reduce access to lethal means such as firearms and medications is recommended for suicidal adults but does not routinely occur. We developed the Web-based <i>Lock to Live</i> (L2L) decision aid to help suicidal adults and their families choose options for safer home storage. OBJECTIVE This study aimed to test the feasibility and acceptability of L2L among suicidal adults in emergency departments (EDs). METHODS At 4 EDs, we enrolled participants (English-speaking, community-dwelling, suicidal adults) in a pilot randomized controlled trial. Participants were randomized in a 13:7 ratio to L2L or control (website with general suicide prevention information) groups and received a 1-week follow-up telephone call. RESULTS Baseline characteristics were similar between the intervention (n=33) and control (n=16) groups. At baseline, many participants reported having access to firearms (33/49, 67%), medications (46/49, 94%), or both (29/49, 59%). Participants viewed L2L for a median of 6 min (IQR 4-10 min). L2L also had very high acceptability; almost all participants reported that they would recommend it to someone in the same situation, that the options felt realistic, and that L2L was respectful of values about firearms. In an exploratory analysis of this pilot trial, more participants in the L2L group reported reduced firearm access at follow-up, although the differences were not statistically significant. CONCLUSIONS The L2L decision aid appears feasible and acceptable for use among adults with suicide risk and may be a useful adjunct to lethal means counseling and other suicide prevention interventions. Future large-scale studies are needed to determine the effect on home access to lethal means. CLINICALTRIAL ClinicalTrials.gov NCT03478501; https://clinicaltrials.gov/ct2/show/NCT03478501

scholarly journals Pilot Randomized Controlled Trial of Web-Delivered Acceptance and Commitment Therapy Versus Smokefree.gov for Smokers With Bipolar Disorder

2019 ◽  
Vol 22 (9) ◽  
pp. 1543-1552 ◽  
Author(s):  
Jaimee L Heffner ◽  
Megan M Kelly ◽  
Jeanette Waxmonsky ◽  
Kristin Mattocks ◽  
Edit Serfozo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Trial Design ◽  
Nicotine Patch ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
Acceptance And Commitment ◽  
End Of Treatment ◽  
Pilot Randomized Controlled Trial

Abstract Introduction Smokers with bipolar disorder (BD) are less successful at quitting than the general population. In this study, we evaluated in a pilot randomized controlled trial a novel, targeted, web-based intervention for smokers with BD based on acceptance and commitment therapy (ACT) and designed for reach and disseminability. Aims and Methods Daily smokers (n = 51) with bipolar I or II disorder were recruited from four US sites and randomly assigned to one of two web-based smoking cessation interventions—ACT-based WebQuit Plus (n = 25) or Smokefree.gov (n = 26) over a 10-week treatment period. All participants received nicotine patch for 8 weeks. Key outcomes were trial design feasibility, intervention acceptability, and cessation at end of treatment and 1-month follow-up. Results We screened 119 to enroll 51 participants (target sample size = 60) over 24 months. The most common reason for ineligibility was the inability to attend study appointments. Retention was 73% at end of treatment and 80% at follow-up, with no differences by arm. The mean number of logins was twice as high for WebQuit Plus (10.3 vs. 5.3). The usefulness of program skills was rated higher for WebQuit Plus (75% vs. 29%). Biochemically confirmed, 7-day abstinence at end of treatment was 12% in WebQuit Plus versus 8% in Smokefree.gov (odds ratio = 1.46, 95% confidence interval = 0.21 to 9.97). At follow-up, abstinence rates were 8% in both arms. Conclusions Trial design produced favorable retention rates, although alternative recruitment methods will be needed for a larger trial. At end of treatment, acceptability and estimated effect size of WebQuit Plus relative to Smokefree.gov were promising and support continued program refinement and evaluation. Implications In this first randomized controlled trial of a targeted intervention for smokers with BD, we found that the ACT-based WebQuit Plus intervention, delivered in combination with the nicotine patch, had promising acceptability and cessation outcomes relative to Smokefree.gov. The observed signals for acceptability and cessation suggest that the WebQuit Plus program should be refined based on participant feedback and evaluated in a larger trial. Feasibility findings from this study also provide direction for refining trial procedures to enhance the recruitment of smokers with BD.

scholarly journals Evaluation of a Web-Based ADHD Awareness Training in Primary Care: Pilot Randomized Controlled Trial With Nested Interviews

10.2196/19871 ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e19871
Author(s):  
Blandine French ◽  
Charlotte Hall ◽  
Elvira Perez Vallejos ◽  
Kapil Sayal ◽  
David Daley
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Awareness Training ◽  
Web Based ◽  
Randomized Controlled ◽  
Specialist Services ◽  
Sham Intervention ◽  
Pilot Randomized Controlled Trial

Background Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder affecting up to 5% of children and adults. Undiagnosed and untreated ADHD can result in adverse long-term health, educational, and social impacts for affected individuals. Therefore, it is important to identify this disorder as early as possible. General practitioners (GPs) frequently play a gatekeeper role in access to specialist services in charge of diagnosis and treatment. Studies have shown that their lack of knowledge and understanding about ADHD can create barriers to care. Objective This pilot randomized controlled trial assesses the efficacy of a web-based psychoeducation program on ADHD tailored for GPs. Methods A total of 221 participants were randomized to either a sham intervention control or an awareness training intervention and they completed questionnaires on ADHD knowledge, confidence, and attitude at 3 time points (preintervention, postintervention, and 2-week follow-up). Participants in the intervention arm were invited to participate in a survey and follow-up interview between 3 and 6 months after the intervention. Results The responses of 109 GPs were included in the analysis. The knowledge (P<.001) and confidence (P<.001) of the GPs increased after the intervention, whereas misconceptions decreased (P=.04); this was maintained at the 2-week follow-up (knowledge, P<.001; confidence, P<.001; misconceptions, P=.03). Interviews and surveys also confirmed a change in practice over time. Conclusions These findings demonstrate that a short web-based intervention can increase GPs’ understanding, attitude, and practice toward ADHD, potentially improving patients’ access to care. Trial Registration International Standard Randomized Controlled Trial Number ISRCTN45400501; http://www.isrctn.com/ISRCTN45400501.

scholarly journals Evaluation of a Web-Based ADHD Awareness Training in Primary Care: Pilot Randomized Controlled Trial With Nested Interviews (Preprint)

2020 ◽  
Author(s):  
Blandine French ◽  
Charlotte Hall ◽  
Elvira Perez Vallejos ◽  
Kapil Sayal ◽  
David Daley
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Awareness Training ◽  
Web Based ◽  
Randomized Controlled ◽  
Specialist Services ◽  
Sham Intervention ◽  
Pilot Randomized Controlled Trial

BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder affecting up to 5% of children and adults. Undiagnosed and untreated ADHD can result in adverse long-term health, educational, and social impacts for affected individuals. Therefore, it is important to identify this disorder as early as possible. General practitioners (GPs) frequently play a gatekeeper role in access to specialist services in charge of diagnosis and treatment. Studies have shown that their lack of knowledge and understanding about ADHD can create barriers to care. OBJECTIVE This pilot randomized controlled trial assesses the efficacy of a web-based psychoeducation program on ADHD tailored for GPs. METHODS A total of 221 participants were randomized to either a sham intervention control or an awareness training intervention and they completed questionnaires on ADHD knowledge, confidence, and attitude at 3 time points (preintervention, postintervention, and 2-week follow-up). Participants in the intervention arm were invited to participate in a survey and follow-up interview between 3 and 6 months after the intervention. RESULTS The responses of 109 GPs were included in the analysis. The knowledge (<i>P</i>&lt;.001) and confidence (<i>P</i>&lt;.001) of the GPs increased after the intervention, whereas misconceptions decreased (<i>P</i>=.04); this was maintained at the 2-week follow-up (knowledge, <i>P</i>&lt;.001; confidence, <i>P</i>&lt;.001; misconceptions, P=.03). Interviews and surveys also confirmed a change in practice over time. CONCLUSIONS These findings demonstrate that a short web-based intervention can increase GPs’ understanding, attitude, and practice toward ADHD, potentially improving patients’ access to care. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN45400501; http://www.isrctn.com/ISRCTN45400501.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

2016 ◽  
Vol 18 (12) ◽  
pp. e313 ◽  
Author(s):  
Sara Ahmed ◽  
Pierre Ernst ◽  
Susan J Bartlett ◽  
Marie-France Valois ◽  
Tasneem Zaihra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Management System ◽  
Controlled Trial ◽  
Self Management ◽  
Web Based ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Use and effect of web-based embodied conversational agents for improving eating behavior and decreasing loneliness among community-dwelling older adults: A randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Lean L. Kramer ◽  
Lex van Velsen ◽  
Jenna L. Clark ◽  
Bob C. Mulder ◽  
Emely de Vet
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Eating Behavior ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Embodied Conversational Agents ◽  
Conversational Agents ◽  
Web Based ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

BACKGROUND Embodied conversational agents (ECAs) have been proposed as a promising interaction modality for the delivery of programs focused on promoting lifestyle changes. However, it is not understood which factors influence use of an ECA and their health effects. OBJECTIVE We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECAs use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. METHODS The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques For this study, an unblinded web-based randomized controlled trial was conducted. Participants were recruited via social media, an online panel, flyers and advertorials. The intervention group received access to the PACO service for eight weeks. The waitlist group received PACO after waiting for four weeks. The primary outcomes, eating behavior and loneliness, were assessed via self-assesed online questionnaires at intake, waitlist, after 4 weeks, and after eight weeks. In addition, the primary outcome—use—was assessed via data logs. Secondary outcomes were measured at the same times, via questionnaires or an optional interview. RESULTS In total, 32 participants completed the intervention. We found a significant correlation between use in minutes on the one hand, and perceived usefulness (r = .39, P =.030) and enjoyment on the other (r = .38, P = .032). However, these did not predict use in the full regression model (F(2,29) = 1.98, P = .16, R2 = .12). Additionally, PACO use did not lead to improvements in eating behavior (χ2(2) = .34, = .85) or a decrease in loneliness (χ2(2) = .02, = .99). CONCLUSIONS Our study did not provide any concluding evidence about factors that are linked to the use or health effects of ECAs. Future service design could benefit from either creating a functional design catered towards the predominant stage of the targeted population, or by personalizing the service based on an intake in which the end-user’s stage is determined. CLINICALTRIAL ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 INTERNATIONAL REGISTERED REPORT RR2-10.2196/22186

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