Dataset Information

Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol.

ABSTRACT: Problem drinking causes great harm to the person and to society. Most problem drinkers will never seek treatment. The current trial will test the efficacy of two Internet interventions for problem drinking - one minimal and the other extended - as an alternate means of providing help to those in need.A double blinded, four-wave panel design with random assignment to two experimental conditions will be used in this study. Participants will be recruited through a comprehensive recruitment strategy consisting of online and print advertisements asking for people who are 'interested in helping us develop and evaluate Internet-based interventions for problem drinkers.' Potential participants will be screened to select problem drinkers who have home access to the Internet. Participants will be sent to a password-protected Internet site and, upon signing in, will be randomized to be provided access to the minimal or extended Internet-based intervention. Six-month, twelve-month, and two-year drinking outcomes will be compared between experimental conditions. The primary hypothesis is that participants in the extended Internet intervention condition will display significantly improved drinking outcomes at twelve months compared to participants in the minimal intervention.The findings of this trial will contribute to the growing literature on Internet interventions for problem drinkers. In addition, findings from this trial will contribute to the scarce literature available evaluating the long-term efficacy of brief interventions for alcohol problems.Clinical Trials.gov # NCT01874509; First submitted June 17, 2013.

SUBMITTER: Cunningham JA

PROVIDER: S-EPMC4308920 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol.

Cunningham John A JA Hendershot Christian S CS Rehm Jürgen J

BMC public health 20150121

<h4>Background</h4>Problem drinking causes great harm to the person and to society. Most problem drinkers will never seek treatment. The current trial will test the efficacy of two Internet interventions for problem drinking - one minimal and the other extended - as an alternate means of providing help to those in need.<h4>Methods/design</h4>A double blinded, four-wave panel design with random assignment to two experimental conditions will be used in this study. Participants will be recruited th ...[more]

PMID: 25604206

Similar Datasets

Project description:BackgroundAlcohol problems are a serious public health concern, and few problem drinkers ever seek treatment. The Internet is one means of promoting access to care, but more research is needed to test the best types of interventions to employ. Evaluation of Internet-based interventions that contain a variety of research-validated cognitive-behavioral tools, which have been shown to be helpful to those with more severe alcohol concerns, should be a priority.ObjectiveTo evaluate whether providing access to an extended Internet intervention for alcohol problems offers additional benefits in promoting reductions in alcohol consumption compared with a brief Internet intervention. The hypothesis for the current trial was that respondents who were provided with access to an extended Internet intervention (the Alcohol Help Center [AHC]) would display significantly improved drinking outcomes at 6-month follow-up, compared with respondents who were provided with access to a brief Internet intervention (the Check Your Drinking [CYD] screener).MethodsA single-blinded randomized controlled trial with a 6-month follow-up. A general population sample of problem drinkers was recruited through newspaper advertisements in a large metropolitan city. Baseline and follow-up data were collected by postal mail.ResultsA volunteer sample of problem drinkers of legal drinking age with home access to the Internet were recruited for the trial. Of 239 potential respondents recruited in 2010, 170 met inclusion criteria (average age 45 years; 101/170, 59.4% male; average Alcohol Use Disorders Identification Test [AUDIT] score of 22). Follow-up rates were 90.0% (153/170) with no adverse effects of the interventions reported. A repeated-measures multivariate analysis of variance of the outcome measures using an intent-to-treat approach found a significantly greater reduction in amount of drinking among participants provided access to the AHC than among participants provided access to the CYD (P = .046).ConclusionsThe provision of the AHC gave additional benefit in the short term to problem drinkers over that seen from the research-validated CYD, indicating the benefits of promoting access to these interventions as one means of helping people with problem drinking concerns.Trial registrationClinicalTrials.gov NCT01114919; http://clinicaltrials.gov/ct2/show/NCT01114919 (Archived by WebCite at http://www.webcitation.org/68t1dCkRZ).

Project description:BackgroundHelping the large number of problem drinkers who will never seek treatment is a challenging issue. Public health initiatives employing educational materials or mass media campaigns have met with mixed success. However, clinical research has developed effective brief interventions to help problem drinkers. This project will employ an intervention that has been validated in clinical settings and then modified into an ultra-brief format suitable for use as a public health intervention. The major objective of this study is to conduct a randomized controlled trial to establish the effectiveness of an ultra-brief, personalized feedback intervention for problem drinkers.Methods/designProblem drinkers recruited on a baseline population telephone survey conducted in a major metropolitan city in Canada will be randomized to one of three conditions - a personalized feedback pamphlet condition, a control pamphlet condition, or a no intervention control condition. In the week after the baseline survey, households in the two pamphlet conditions will be sent their respective pamphlets. Changes in drinking will be assessed post intervention at three-month and six-month follow-ups. Drinking outcomes will be compared between experimental conditions using Structural Equation Modeling. The primary hypothesis is that problem drinkers from households who receive the personalized feedback pamphlet intervention will display significantly improved drinking outcomes at three and six-month follow-ups as compared to problem drinkers from households in the no intervention control condition. Secondary hypotheses will test the impact of the intervention on help seeking, and explore the mediating or moderating role of perceived drinking norms, perceived alcohol risks and the problem drinker's social reasons for drinking.DiscussionThis trial will provide information on the effectiveness of a pamphlet-based personalized feedback intervention for problem drinkers in a community setting.Trial registrationClinicalTrials.gov registration #NCT00688584.

Project description:Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help.Trial registrationClinicaltrials.gov as NCT04074681. Registered 22 July 2019.

Project description:BACKGROUND:The literature shows that computer-delivered interventions with personalized normative feedback can reduce problem drinking for up to 6 months in the West. Meanwhile, no studies have been conducted to examine the effects of such interventions among Japanese problem drinkers. Possible moderators associated with effectiveness of the intervention need to be also explored. OBJECTIVE:The purpose of this study is to conduct a trial and examine the efficacy of a brief intervention with personal normative feedback and psychoeducation on several measures of alcohol consumption among Japanese problem drinkers. Additionally, this study will examine whether the level of alcohol use disorder and beliefs about the physical and psychological outcomes of drinking moderate the effect of the intervention on outcome measures. METHODS:This study will conduct a single-blind, 2-armed randomized controlled trial. Japanese adults with an Alcohol Use Disorder Identification Test score of 8 or higher will be enrolled in the trial. Participants allocated to the intervention group will receive the intervention immediately after the baseline measurements, and participants allocated to the waitlist group will receive the intervention at the end of the trial. Outcome measures include drinking quantity, drinking frequency, and alcohol-related consequences. Follow-up assessment will take place at 1 month, 2 months, and 6 months following the baseline measurement. The authors will not know the group allocation during trial. The authors will plan to collect a sample of 600 participants. Mixed-effect analyses of variance will be used to examine the main effects of condition, the main effects of time, and the interaction effects between condition and time on outcome variables. RESULTS:Enrollment for the trial began on January 6, 2018 and data are expected to be available by August 2018. CONCLUSIONS:This study will contribute to the literature by demonstrating the efficacy of Web-based screenings and brief interventions among Japanese problem drinkers and indicating several possible moderators between the intervention and outcomes. This type of Web-based brief intervention has the possibility of being implemented in Japanese schools and workplaces as a prevention tool. TRIAL REGISTRATION:UMIN Clinical Trials Registry R000034388; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000034388 (Archived by WebCite at http://www.webcitation.org/6xmOoTfTI). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10650.

Project description:Internet-based interventions for heavy drinkers show promising results, but existing research is characterized by few studies in nonstudent adult populations and few comparisons with appropriate control groups.To test whether a fully automated Internet-based brief personalized feedback intervention and a fully automated Internet-based personalized brief advice intervention in a non-treatment-seeking population of heavy drinkers would result in a reduced alcohol intake.We conducted a 3-arm parallel randomized controlled trial in a general population-based sample of heavy drinkers. The 54,157 participants (median age of 58 years) were screened for heavy drinking. Of the 3418 participants who had a weekly alcohol consumption above 14 drinks for women and 21 drinks for men, 1380 (619 women) consented to take part in the trial and were randomly assigned to an Internet-based brief personalized feedback intervention group (normative feedback, n = 476), an Internet-based personalized brief advice intervention group (n = 450), or a nonintervention control group (n = 454). Follow-up after 6 and 12 months included 871 and 1064 participants, respectively, of all groups combined. The outcome measure was self-reported weekly alcohol consumption. We analyzed the data according to the intention-to-treat principle. To examine changes over time and to account for the multiple time measurements, we used a multilevel linear mixed model. To take attrition into account, we used multiple imputation to address missing data.The intervention effect of the Internet-based brief personalized feedback intervention, determined as the mean additional difference in changes in alcohol consumption in the Internet-based brief personalized feedback intervention compared with the control group, was -1.8 drinks/week after 6 months and -1.4 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval -4.0 to 0.3 at 6 months, -3.4 to 0.6 at 12 months). The intervention effect of the Internet-based personalized brief advice intervention was -0.5 drinks/week after 6 months and -1.2 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval -2.7 to 1.6 at 6 months, -3.3 to 0.9 at 12 months).In this randomized controlled trial we found no evidence that an Internet-based brief personalized feedback intervention was effective in reducing drinking in an adult population of heavy drinkers.ClinicalTrials.gov NCT00751985; http://clinicaltrials.gov/ct2/show/NCT00751985 (Archived by WebCite at http://www.webcitation.org/68WCRLyaP).

Dataset Information

Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol.

Publications

Randomized controlled trial of a minimal versus extended Internet-based intervention for problem drinkers: study protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets