scholarly journals A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial

10.2196/15438 ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. e15438
Author(s):  
José Manuel Martinez-Montilla ◽  
Liesbeth Mercken ◽  
Hein de Vries ◽  
Math Candel ◽  
Joaquín Salvador Lima-Rodríguez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Regression Analysis ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Controlled Trial ◽  
Baseline Assessment ◽  
Web Based ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Alcohol consumption, including binge drinking (BD) and heavy episodic drinking (HED), is one of the leading risk factors among Spanish adolescents leading to significant social, health, and economic consequences. Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person’s individual characteristics and needs. Randomized controlled trials assessing the effects of tailored BD reduction programs among Spanish adolescents are scarce. Objective The aim of this study was to test the effectiveness of the Web-based, CT intervention Alerta Alcohol, aimed at the prevention of BD in Spanish adolescents. As a secondary outcome, effects on HED, weekly consumption, and any consumption were also assessed. The adherence and process evaluation were assessed. Methods A cluster randomized controlled trial conducted among 15 Spanish schools was developed. Each school was randomized into either an experimental condition (EC) (N=742) or a control condition (CC) (N=505). Finally, 351 participants for the EC and 261 for the CC were included in the analysis (N=612). Baseline assessment took place in January and February 2017. Demographic variables and alcohol use were assessed at baseline. Follow-up assessment of alcohol use took place 4 months later in May and June 2017. Participants were compared according to their randomization group (EC versus CC). After the baseline assessment, participants in the EC started the intervention, which consisted of short stories about BD, in which CT feedback was based on the I-Change Model for behavior change. Participants in the CC group only received the baseline questionnaire. Effects of the intervention were assessed using a three-level mixed logistic regression analysis for BD, HED, and any consumption, and a three-level mixed linear regression analysis for weekly consumption. Results In total, 1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the attrition rate was 50.92%. The intervention was effective in reducing HED among adolescents; the odds of HED in the CC was nine times that in the experimental condition (P=.04). No effects were found for BD, weekly consumption, and any consumption. Process evaluations revealed that the adolescents were satisfied with the program (68.8%), would use the program again (52.9%), and would recommend it to someone else (62.8%). Females and non-binge drinkers showed better responses in the process evaluation. Conclusions Our intervention was effective regarding HED but not regarding BD, weekly consumption, and any consumption. It may be that limiting alcohol consumption to prevent HED was easier in the Spanish context than it was to carry out further steps, such as reducing other patterns of alcohol consumption. Hence, additional actions are needed to accomplish these latter goals, including community approaches and policy actions aimed at denormalizing alcohol consumption among Spanish adolescents. Trial Registration ClinicalTrials.gov NCT03288896; https://clinicaltrials.gov/ct2/show/NCT03288896 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5346-4

A Web-Based, Computer-Tailored Intervention to Reduce Alcohol Consumption and Binge Drinking Among Spanish Adolescents: Cluster Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
José Manuel Martinez-Montilla ◽  
Liesbeth Mercken ◽  
Hein de Vries ◽  
Math Candel ◽  
Joaquín Salvador Lima-Rodríguez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Regression Analysis ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Controlled Trial ◽  
Baseline Assessment ◽  
Web Based ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Alcohol consumption, including binge drinking (BD) and heavy episodic drinking (HED), is one of the leading risk factors among Spanish adolescents leading to significant social, health, and economic consequences. Reduction of BD and HED in adolescents can be achieved using Web-based, computer-tailored (CT) interventions, providing highly personalized feedback that is adapted to a person’s individual characteristics and needs. Randomized controlled trials assessing the effects of tailored BD reduction programs among Spanish adolescents are scarce. OBJECTIVE The aim of this study was to test the effectiveness of the Web-based, CT intervention Alerta Alcohol, aimed at the prevention of BD in Spanish adolescents. As a secondary outcome, effects on HED, weekly consumption, and any consumption were also assessed. The adherence and process evaluation were assessed. METHODS A cluster randomized controlled trial conducted among 15 Spanish schools was developed. Each school was randomized into either an experimental condition (EC) (N=742) or a control condition (CC) (N=505). Finally, 351 participants for the EC and 261 for the CC were included in the analysis (N=612). Baseline assessment took place in January and February 2017. Demographic variables and alcohol use were assessed at baseline. Follow-up assessment of alcohol use took place 4 months later in May and June 2017. Participants were compared according to their randomization group (EC versus CC). After the baseline assessment, participants in the EC started the intervention, which consisted of short stories about BD, in which CT feedback was based on the I-Change Model for behavior change. Participants in the CC group only received the baseline questionnaire. Effects of the intervention were assessed using a three-level mixed logistic regression analysis for BD, HED, and any consumption, and a three-level mixed linear regression analysis for weekly consumption. RESULTS In total, 1247 adolescents participated in the baseline assessment and 612 participated in the follow-up assessment; the attrition rate was 50.92%. The intervention was effective in reducing HED among adolescents; the odds of HED in the CC was nine times that in the experimental condition (<i>P</i>=.04). No effects were found for BD, weekly consumption, and any consumption. Process evaluations revealed that the adolescents were satisfied with the program (68.8%), would use the program again (52.9%), and would recommend it to someone else (62.8%). Females and non-binge drinkers showed better responses in the process evaluation. CONCLUSIONS Our intervention was effective regarding HED but not regarding BD, weekly consumption, and any consumption. It may be that limiting alcohol consumption to prevent HED was easier in the Spanish context than it was to carry out further steps, such as reducing other patterns of alcohol consumption. Hence, additional actions are needed to accomplish these latter goals, including community approaches and policy actions aimed at denormalizing alcohol consumption among Spanish adolescents. CLINICALTRIAL ClinicalTrials.gov NCT03288896; https://clinicaltrials.gov/ct2/show/NCT03288896 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-018-5346-4

scholarly journals Detection of Domestic Violence and Abuse by Community Mental Health Teams Using the BRAVE Intervention: A Multicenter, Cluster Randomized Controlled Trial

2021 ◽  
pp. 088626052110041
Author(s):  
Roos Ruijne ◽  
Cornelis Mulder ◽  
Milan Zarchev ◽  
Kylee Trevillion ◽  
Roel van Est ◽  
...  
Keyword(s):  
Mental Health ◽  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Referral Rates ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
And Control ◽  
Domestic Violence And Abuse

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended.

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 Evaluation of a Brief Intervention for Promoting Mental Health among Employees in Social Enterprises: A Cluster Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2107 ◽  
Author(s):  
Benedicte Deforche ◽  
Jasmine Mommen ◽  
Anne Hublet ◽  
Winnie De Roover ◽  
Nele Huys ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Social Enterprises ◽  
Randomized Controlled ◽  
Cluster Randomized

Evidence on the effectiveness of workplace mental health promotion for people with disabilities is limited. This study aimed to evaluate the effectiveness of a brief mental health promotion intervention in social enterprises. It had a non-blinded cluster randomized controlled trial design with follow-up one and four months after the intervention. In total 196 employees agreed to participate (86 intervention and 110 control). Empowerment was the main outcome; secondary outcomes were resilience, palliative behavior, determinants of four coping strategies of mental health, quality of life, and life satisfaction. A brief participant satisfaction survey was conducted after the intervention. No significant intervention effect on empowerment was found. However, at one month follow-up, significant favorable effects were found on perceived social support for coping strategies for mental health and on palliative behavior. At four months follow-up, favorable intervention effects were found on quality of life, but unfavorable effects were found on unjustified worrying. In addition, the intervention was well received by the employees. This brief intervention might be a promising first step to improve mental health in people with disabilities working in social enterprises. Nevertheless, additional monitoring by professionals and managers working in the organizations might be needed to maintain these effects.

Physicians’ Choice in Using Internet and Fax for Patient Recruitment and Follow-up in a Randomized Controlled Trial

2004 ◽  
Vol 43 (03) ◽  
pp. 268-272 ◽  
Author(s):  
S. Morita ◽  
T. Fukui ◽  
J. Sakamoto ◽  
M. Rahman
Keyword(s):  
Randomized Controlled Trial ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Data Entry ◽  
Regression Analyses ◽  
Multivariate Logistic Regression ◽  
Web Based ◽  
Randomized Controlled ◽  
The Web

Summary Objective: To examine the physicians’ preference between Web and fax-based remote data entry (RDE) system for an ongoing randomized controlled trial (RCT) in Japan. Methods: We conducted a survey among all the collaborating physicians (n = 512) of the CASE-J (Candesartan Antihypertensive Survival Evaluation in Japan) trial, who have been recruiting patients and sending follow-up data using the Web or a fax-based RDE system. The survey instrument assessed physicians’ choice between Web and fax-based RDE systems, their practice pattern, and attitudes towards these two modalities. Results: A total of 448 (87.5%) responses were received. The proportions of physicians who used Web, fax, and the combination of these two were 45.9%, 33.3% and 20.8%, respectively. Multivariate logistic regression analyses revealed that physicians 55 years or younger [odds ratio (OR) = 1.9, 95% confidence interval (CI) = 1.1-3.3] and regular users of computers (OR = 4.2, 95% CI = 2.1-8.2) were more likely to use the Web-based RDE system. Conclusions: This information would be useful in designing an RCT with a Web-based RDE system in Japan and abroad.

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 Guided web-based treatment program for reducing cannabis use: a randomized controlled trial

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Kristina Sinadinovic ◽  
Magnus Johansson ◽  
Ann-Sofie Johansson ◽  
Thomas Lundqvist ◽  
Philip Lindner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Program ◽  
Controlled Trial ◽  
Cannabis Use ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled ◽  
Intervention Adherence ◽  
Group Effects

Abstract Background The aim of this study was to investigate the effects of a web-based treatment program with therapist guidance for adults and adolescents with regular cannabis use from the general population. Methods A double blinded randomized controlled trial with a parallel group design was conducted (intervention group n = 151, wait-list control group n = 152). Follow-up 12 weeks from treatment commencement of a 13-module intervention. The primary outcome was frequency of cannabis use. Time by group interaction effects were modeled using generalized estimated equations and the instrumental variable approach was used to estimate the effect of intervention adherence. Results At follow-up, the intention to treat (ITT) analyses did not show any significant time by group effects. A significant association between intervention adherence and scores on the cannabis abuse screening test (CAST) was found. Secondary analysis excluding participants who had received other professional help revealed time by group effects for secondary outcomes gram cannabis consumed past week, number of dependency criteria and CAST score. Due to methodological limitations, these latter results should be interpreted with caution. Conclusions In this study we did not find a web-based treatment program with therapist guidance to be more effective than a waiting-list in reducing frequency of cannabis use. Trial registration The trial was pre-registered at ClinicalTrials.gov (NCT02408640) April 3, 2015

Alcohol Use Disorder and Comorbid Depression: A Randomized Controlled Trial Investigating the Effectiveness of Supportive Text Messages in Aiding Recovery

2019 ◽  
Vol 54 (5) ◽  
pp. 551-558 ◽  
Author(s):  
Helen O’Reilly ◽  
Aisling Hagerty ◽  
Seamus O’Donnell ◽  
Aoife Farrell ◽  
Dan Hartnett ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Alcohol Use Disorder ◽  
Controlled Trial ◽  
Text Messages ◽  
Comorbid Depression ◽  
Randomized Controlled ◽  
Lower Alcohol ◽  
The Impact

This randomized controlled trial examined the impact of daily supportive text messages over a six-month treatment period on mood and alcohol consumption in individuals with a dual diagnosis of alcohol use disorder (AUD) and depression. Results highlighted mood benefits at 3-month and lower alcohol consumption at 6-month treatment points.

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