A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): study protocol for a parallel group randomised controlled trial.
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ABSTRACT:
SUBMITTER: Lubman DI
PROVIDER: S-EPMC6701125 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
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A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): study protocol for a parallel group randomised controlled trial.
Lubman Dan I DI Grigg Jasmin J Manning Victoria V Hall Kate K Volpe Isabelle I Dias Stephanie S Baker Amanda A K Staiger Petra P Reynolds John J Harris Anthony A Tyler Jonathan J Best David D
Trials 20190819 1
<h4>Background</h4>Current population surveys suggest around 20% of Australians meet diagnostic criteria for an alcohol use disorder. However, only a minority seek professional help due to individual and structural barriers, such as low health literacy, stigma, geography, service operating hours and wait lists. Telephone-delivered interventions are readily accessible and ideally placed to overcome these barriers. We will conduct a randomised controlled trial (RCT) to examine the efficacy of a st ...[more]
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Project description:BackgroundAustralia has one of the highest rates of methamphetamine (MA) use in the world; however, uptake of in-person psychological treatment remains extremely low due to numerous individual (e.g. stigma, shame) and structural (e.g. service accessibility, geographical location) barriers to accessing care. Telephone-delivered interventions are ideally placed to overcome many of the known barriers to treatment access and delivery. This randomised controlled trial (RCT) will examine the efficacy of a standalone, structured telephone-delivered intervention to reduce MA problem severity and related harms.MethodsThis study is a double-blind, parallel-group RCT. We will recruit 196 ± 8 individuals with mild to moderate MA use disorder from across Australia. After eligibility and baseline assessments, participants will be randomly allocated to receive either the Ready2Change-Methamphetamine (R2C-M) intervention (n = 98 ± 4; four to six telephone-delivered intervention sessions, R2C-M workbooks and MA information booklet) or control (n = 98 ± 4; four to six ≤5-min telephone check-ins and MA information booklet including information on accessing further support). Telephone follow-up assessments will occur at 6 weeks and 3, 6 and 12 months post-randomisation. The primary outcome is change in MA problem severity (Drug Use Disorders Identification Test, DUDIT) at 3 months post-randomisation. Secondary outcomes are as follows: MA problem severity (DUDIT) at 6 and 12 months post-randomisation, amount of methamphetamine used, methamphetamine use days, methamphetamine use disorder criteria met, cravings, psychological functioning, psychotic-like experiences, quality of life and other drug use days (at some or all timepoints of 6 weeks and 3, 6 and 12 months post-randomisation). Mixed-methods program evaluation will be performed and cost-effectiveness will be examined.DiscussionThis study will be the first RCT internationally to assess the efficacy of a telephone-delivered intervention for MA use disorder and related harms. The proposed intervention is expected to provide an effective, low-cost, scalable treatment for individuals otherwise unlikely to seek care, preventing future harms and reducing health service and community costs.Trial registrationClinicalTrials.gov NCT04713124 . Pre-registered on 19 January 2021.
| S-EPMC10052286 | biostudies-literature
Project description:BACKGROUND:Presently, 6.5 million Americans are living with heart failure (HF). These patients are expected to follow a complex self-management regimen at home. Several demographic and psychosocial factors limit patients with HF in following the prescribed self-management recommendations at home. Poor self-care is associated with increased hospital re-admissions. Under the Affordable Care Act, there are financial implications related to hospital re-admissions for hospitals and programs such as the Program of All-Inclusive Care for the Elderly (PACE) in Pinellas County, Florida. Previous studies and systematic reviews demonstrated improvement in self-management and quality of life (QoL) in patients with HF with structured telephone support (STS) and short message service text messaging (SMS). OBJECTIVE:This study aimed to evaluate the effects of STS and SMS on self-care, knowledge, medication adherence, and QoL of patients with HF. METHODS:A prospective quality improvement project using a pre-post design was implemented. Data were collected at baseline, 30 days, and 3 months from 51 patients with HF who were enrolled in PACE in Pinellas County, Florida. All participants received STS and SMS for 30 days. The feasibility and sustained benefit of using STS and SMS was assessed at a 3-month follow-up. RESULTS:A paired t test was used to compare the mean difference in HF outcomes at the baseline and 30-day follow-up, which demonstrated improved HF self-care maintenance (t49=0.66; P=.01), HF knowledge (t49=0.71; P=.01), medication adherence (t49=0.92; P=.01), and physical and mental health measured using Short-Form-12 (SF-12; t49=0.81; P=.01). The results also demonstrated the sustained benefit with improved HF self-care maintenance, self-care management, self-care confidence, knowledge, medication adherence, and physical and mental health (SF-12) at 3 months with P<.05 for all outcomes. Living status and social support had a strong correlation with HF outcomes. Younger participants (aged less than 65 years) performed extremely well compared with older adults. CONCLUSIONS:STS and SMS were feasible to use among PACE participants with sustained benefits at 3 months. Implementing STS and SMS may serve as viable options to improve HF outcomes. Improving outcomes with HF affects hospital systems and the agencies that monitor and provide care for outpatients and those in independent or assisted-living facilities. Investigating viable options and support for implementation will improve outcomes.
| S-EPMC7055840 | biostudies-literature
Project description:There is an evidence-practice gap between the dietary recommendations for age-related macular degeneration (AMD) presented in the literature and those practiced by patients. This study reports on the 3-month post-intervention results of a randomised controlled trial (RCT) evaluating telephone-delivered counselling to improve dietary behaviours among AMD patients. A total of 155 AMD patients (57% female, aged 78 ± 8 years; control: 78, intervention: 77), primarily residing in New South Wales, Australia, were recruited. Participants completed a baseline questionnaire and a short dietary questionnaire (SDQ-AMD). The intervention included an evidence-based nutrition resource and four monthly calls with a dietitian. Immediately post-intervention, intervention participants repeated the SDQ-AMD and completed a feedback form. At 3 months post-intervention, both study arms repeated the SDQ-AMD. Statistical analyses included t-tests and McNemar's test. Intervention participants reported satisfaction with the tailored phone calls, nutrition resource and nutrition education provided. At 3 months post-intervention, there was no statistically significant difference between study arms in the proportion of participants meeting the dietary goals nor in intake (mean servings ± SE) of total vegetables (primary outcome) and other key food groups; however, there was a significantly higher intake of nuts (secondary outcome) (3.96 ± 0.51 vs. 2.71 ± 0.32; p = 0.04) among participants in the intervention versus control group. Within the intervention arm, there were also significant improvements in intakes of the following secondary outcomes: dark green leafy vegetables (0.99 ± 0.17 vs. 1.71 ± 0.22; p = 0.003) and legumes (0.69 ± 0.10 vs. 1.12 ± 0.16; p = 0.02) and intake of sweets and processed/prepared foods (8.31 ± 0.76 vs. 6.54 ± 0.58, p = 0.01). In summary, although there were few dietary differences between study arms at 3 months post-intervention, the intervention involving four monthly calls was acceptable and helpful to the participants. This type of intervention therefore has the potential to provide people with AMD the needed support for improving their nutrition knowledge and dietary practices, especially if continued over a longer period.
| S-EPMC7650817 | biostudies-literature
Project description:Problem gambling is a serious public health concern at an international level where population prevalence rates average 2% or more and occurs more frequently in younger populations. The most empirically established treatments until now are combinations of cognitive and behavioural techniques labelled cognitive behaviour therapy (CBT). However, there is a paucity of high quality evidence for the comparative efficacy of core CBT interventions in treating problem gamblers. This study aims to isolate and compare cognitive and behavioural (exposure-based) techniques to determine their relative efficacy.A sample of 130 treatment-seeking problem gamblers will be allocated to either cognitive or exposure therapy in a two-group randomised, parallel design. Repeated measures will be conducted at baseline, mid and end of treatment (12 sessions intervention period), and at 3, 6 and 12 months (maintenance effects). The primary outcome measure is improvement in problem gambling severity symptoms using the Victorian Gambling Screen (VGS) harm to self-subscale. VGS measures gambling severity on an extensive continuum, thereby enhancing sensitivity to change within and between individuals over time.This article describes the research methods, treatments and outcome measures used to evaluate gambling behaviours, problems caused by gambling and mechanisms of change. This study will be the first randomised, parallel trial to compare cognitive and exposure therapies in this population.The study was approved by the Southern Adelaide Health Service/Flinders University Human Research Ethics Committee. Study findings will be disseminated through peer-reviewed publications and conference presentations.Australian New Zealand Clinical Trials Registry: ACTRN 12610000828022.
| S-EPMC3696861 | biostudies-other
Project description:BACKGROUND:The consumption of alcohol and other drugs causes social and health problems in industrialized societies. Furthermore, alcohol and drug consumption in the workplace is associated with work accidents, absenteeism and low productivity. The aim of the current study is to reduce alcohol and drug consumption among workers in the service industry and, as a secondary aim, to improve their healthy habits through the reduction of alcohol and other drug consumption in their leisure time. METHODS:This nonrandomized, single-group study was conducted in 12 work centers. The intervention began in 2009 and emphasized 1) health promotion and health monitoring, which included a) alcohol and drug awareness and b) the evaluation and monitoring of alcohol and drug consumption through a semistructured interview designed to assess risky consumption; urine tests aimed at detecting alcohol, cannabis and cocaine use; an Alcotest based on expired air to test for the recent consumption of alcohol and a saliva exam to test for the recent consumption of six drugs; and 2) secondary prevention if risky consumption was identified. Risky alcohol consumption was defined as the ingestion of more than 28 standard drink units (SDUs)/week among men and more than 17 SDUs/week among women (taking into account both work and leisure time). Drug consumption was considered risky consumption. RESULTS:A total of 1103 workers participated, and each received 5 h of awareness training. Those who presented with risky consumption received secondary prevention training. The prevalence of risky alcohol consumption decreased by 4.1% (baseline: 14.7% reduced to 10.6% in the first year; p?=?0.001), a reduction that was maintained over a 3-year follow-up period. CONCLUSION:A comprehensive program of worker health surveillance that involves stakeholders and includes monitoring can be a means of potentially improving compliance with workplace promotion programs, resulting in the facilitation of such beneficial, desired behavior change in areas such as alcohol and drug consumption.
| S-EPMC6247683 | biostudies-other
Project description:Introduction and aimsMost women cut down or quit alcohol use during pregnancy, but return to pre-pregnancy levels of use after giving birth. Universal screening and brief intervention for alcohol use has shown promise, but has proven challenging to implement and has rarely been evaluated with postpartum women. This trial evaluated a single 20-min, electronic screening and brief intervention (e-SBI) for alcohol use among postpartum women.Design and methodsIn this parallel group randomised trial, 123 postpartum, low-income, primarily African-American women meeting criteria for unhealthy alcohol use were randomly assigned to either a tailored e-SBI (n = 61) or a time-matched control condition (n = 62), with follow-up at 3 and 6 months. Hypotheses predicted that 7-day point-prevalence abstinence and drinking days would favour the e-SBI condition.ResultsNo group differences were significant. Blinded follow-up evaluation revealed 7-day point prevalence of 75% for the e-SBI condition versus 82% for control at 3 months (odds ratio = 1.6) and 72% versus 73%, respectively, at 6 months. Drinking days in the past 90 and mean number of drinks per week also showed no significant differences.Discussion and conclusionsThis pilot trial failed to support a single-session e-SBI for alcohol use among postpartum women, although findings at the 3-month time point suggested that greater power might confirm transient effects of the e-SBI. As efficacy is likely to vary with e-SBI content and approach, future research should leverage technology's reproducibility and modularity to isolate key components. [Ondersma SJ, Svikis DS, Thacker LR, Beatty JR, Lockhart N. A randomised trial of a computer-delivered screening and brief intervention for postpartum alcohol use. Drug Alcohol Rev 2016;35:710-718].
| S-EPMC5035162 | biostudies-literature
Project description:BackgroundAnxiety is commonly experienced by people living with mild cognitive impairment (MCI) and dementia. Whilst there is strong evidence for late-life anxiety treatment using cognitive behavioural therapy (CBT) and delivery via telehealth, there is little evidence for the remote delivery of psychological treatment for anxiety in people living with MCI and dementia. This paper reports the protocol for the Tech-CBT study which aims to investigate the efficacy, cost-effectiveness, usability and acceptability of a technology-assisted and remotely delivered CBT intervention to enhance delivery of anxiety treatment for people living with MCI and dementia of any aetiology.MethodsA hybrid II single-blind, parallel-group randomised trial of a Tech-CBT intervention (n = 35) versus usual care (n = 35), with in-built mixed methods process and economic evaluations to inform future scale-up and implementation into clinical practice. The intervention (i) consists of six weekly sessions delivered by postgraduate psychology trainees via telehealth video-conferencing, (ii) incorporates voice assistant app technology for home-based practice, and (iii) utilises a purpose-built digital platform, My Anxiety Care. The primary outcome is change in anxiety as measured by the Rating Anxiety in Dementia scale. Secondary outcomes include change in quality of life and depression, and outcomes for carers. The process evaluation will be guided by evaluation frameworks. Qualitative interviews will be conducted with a purposive sample of participants (n = 10) and carers (n = 10), to evaluate acceptability and feasibility, as well as factors influencing participation and adherence. Interviews will also be conducted with therapists (n = 18) and wider stakeholders (n = 18), to explore contextual factors and barriers/facilitators to future implementation and scalability. A cost-utility analysis will be undertaken to determine the cost-effectiveness of Tech-CBT compared to usual care.DiscussionThis is the first trial to evaluate a novel technology-assisted CBT intervention to reduce anxiety in people living with MCI and dementia. Other potential benefits include improved quality of life for people with cognitive impairment and their care partners, improved access to psychological treatment regardless of geographical location, and upskilling of the psychological workforce in anxiety treatment for people living with MCI and dementia.Trial registrationThis trial has been prospectively registered with ClinicalTrials.gov: NCT05528302 [September 2, 2022].
| S-EPMC10280938 | biostudies-literature
Project description:IntroductionThe prevalence of at-risk drinking is far higher among those in contact with the criminal justice system (73%) than the general population (35%). However, there is little evidence on the effectiveness of alcohol brief interventions (ABIs) in reducing risky drinking among those in the criminal justice system, including the prison system and, in particular, those on remand. Building on earlier work, A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement (APPRAISE) is a pilot study designed to assess the feasibility and acceptability of an ABI, delivered to male prisoners on remand. The findings of APPRAISE should provide the information required to design a future definitive randomised controlled trial (RCT).Methods and analysisAPPRAISE will use mixed methods, with two linked phases, across two prisons in the UK, recruiting 180 adult men on remand: 90 from Scotland and 90 from England. Phase I will involve a two-arm, parallel-group, individually randomised pilot study. The pilot evaluation will provide data on the likely impact of A two-arm parallel group individually randomised Prison Pilot study of a male Remand Alcohol Intervention for Self-efficacy Enhancement (APPRAISE), which will be used to inform a future definitive multicentre RCT. Phase II will be a process evaluation assessing how the ABI has been implemented to explore the change mechanisms underpinning the ABI (figure 1) and to assess the context within which the ABI is delivered.Ethics and disseminationThe APPRAISE protocol has been approved by the East of Scotland Research Ethics Committee (19/ES/0068), National Offender Management System (2019-240), Health Board Research and Development (2019/0268), Scottish Prison Service research and ethics committee, and by the University of Edinburgh's internal ethics department. The findings will be disseminated via peer-reviewed journal publications, presentations at local, national and international conferences, infographics and shared with relevant stakeholders through meetings and events.Trial registration numberISRCTN27417180.
| S-EPMC8023744 | biostudies-literature
Project description:BackgroundThere is strong evidence to support the effectiveness of Brief Intervention (BI) in reducing alcohol consumption in primary healthcare.Methods and designThis study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older) will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours) on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT) administered by telephone.DiscussionThe UK Department of Health's stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design.Trial registrationCurrent Controlled Trials ISRCTN95216873.
| S-EPMC3583737 | biostudies-literature
Project description:IntroductionThere are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt.AimTo determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt.Methods and analysisThree-phase development and feasibility study with embedded process evaluation. Phase I comprises tailoring an SPI with telephone follow-up originally designed for veterans in the USA, for use in the UK. Phase II involves piloting the intervention with patients (n=30) who have been hospitalised following a suicide attempt. Phase III is a feasibility randomised controlled trial of 120 patients who have been hospitalised following a suicide attempt with a 6-month follow-up. Phase III participants will be recruited from across four National Health Service hospitals in Scotland and randomised to receive either the SPI with telephone follow-up and treatment as usual (n=80) or treatment as usual only (n=40). The primary outcomes are feasibility outcomes and include the acceptability of the intervention to participants and intervention staff, the feasibility of delivery in this setting, recruitment, retention and intervention adherence as well as the feasibility of collecting the self-harm re-admission to hospital outcome data. Statistical analyses will include description of recruitment rates, intervention adherence/use, response rates and estimates of the primary outcome event rates, and intervention effect size (Phase III). Thematic analyses will be conducted on interview and focus group data.Ethics and disseminationThe East of Scotland Research Ethics Service (EoSRES) approved this study in March 2017 (GN17MH101 Ref: 17/ES/0036). The study results will be disseminated via peer-reviewed publication and conference presentations. A participant summary paper will also be disseminated to patients, service providers and policy makers alongside the main publication.Trial registration numberISRCTN62181241.
| S-EPMC6377516 | biostudies-literature