Digital Smoking Cessation Intervention for Cancer Survivors: Analysis of Predictors and Moderators of Engagement and Outcome Alongside a Randomized Controlled Trial.

BACKGROUND: Recent studies have shown positive, though small, clinical effects of digital smoking cessation (SC) interventions for cancer survivors. However, research on associations among participant characteristics, intervention engagement, and outcomes is limited. OBJECTIVE: This study aimed to explore the predictors and moderators of engagement and outcome of MyCourse-Quit Smoking (in Dutch: "MijnKoers-Stoppen met Roken"), a digital minimally guided intervention for cancer survivors. METHODS: A secondary analysis of data from the randomized controlled trial was performed. The number of cigarettes smoked in the past 7 days at 6-month follow-up was the primary outcome measure. We analyzed interactions among participant characteristics (11 variables), intervention engagement (3 variables), and outcome using robust linear (mixed) modeling. RESULTS: In total, 165 participants were included in this study. Female participants accessed the intervention less often than male participants (B=-11.12; P=.004). A higher Alcohol Use Disorders Identification Test score at baseline was associated with a significantly higher number of logins (B=1.10; P<.001) and diary registrations (B=1.29; P<.001). A higher Fagerström Test for Nicotine Dependence score at baseline in the intervention group was associated with a significantly larger reduction in tobacco use after 6 months (B=-9.86; P=.002). No other associations and no moderating effects were found. CONCLUSIONS: Overall, a limited number of associations was found between participant characteristics, engagement, and outcome, except for gender, problematic alcohol use, and nicotine dependence. Future studies are needed to shed light on how this knowledge can be used to improve the effects of digital SC programs for cancer survivors. TRIAL REGISTRATION: Netherlands Trial register NTR6011/NL5434; https://onderzoekmetmensen.nl/nl/trial/22832.

Action Opportunities to Pursue Responsible Digital Care for People With Intellectual Disabilities: Qualitative Study.

BACKGROUND: Responsible digital care refers to any intentional systematic effort designed to increase the likelihood of a digital care technology developed through ethical decision-making, being socially responsible and aligned with the values and well-being of those impacted by it. OBJECTIVE: We aimed to present examples of action opportunities for (1) designing "technology"; (2) shaping the "context" of use; and (3) adjusting the behavior of "users" to guide responsible digital care for people with intellectual disabilities. METHODS: Three cases were considered: (1) design of a web application to support the preparation of meals for groups of people with intellectual disabilities, (2) implementation of an app to help people with intellectual disabilities regulate their stress independently, and (3) implementation of a social robot to stimulate interaction and physical activity among people with intellectual disabilities. Overall, 26 stakeholders participated in 3 multistakeholder workshops (case 1: 10/26, 38%; case 2: 10/26, 38%; case 3: 6/26, 23%) based on the "guidance ethics approach." We identified stakeholders' values based on bottom-up exploration of experienced and expected effects of using the technology, and we formulated action opportunities for these values in the specific context of use. Qualitative data were analyzed thematically. RESULTS: Overall, 232 effects, 33 values, and 156 action opportunities were collected. General and case-specific themes were identified. Important stakeholder values included quality of care, autonomy, efficiency, health, enjoyment, reliability, and privacy. Both positive and negative effects could underlie stakeholders' values and influence the development of action opportunities. Action opportunities comprised the following: (1) technology: development of the technology (eg, user experience and customization), technology input (eg, recipes for meals, intervention options for reducing stress, and activities), and technology output (eg, storage and use of data); (2) context: guidelines, training and support, policy or agreements, and adjusting the physical environment in which the technology is used; and (3) users: integrating the technology into daily care practice, by diminishing (eg, "letting go" to increase the autonomy of people with intellectual disabilities), retaining (eg, face-to-face contact), and adding (eg, evaluation moments) certain behaviors of care professionals. CONCLUSIONS: This is the first study to provide insight into responsible digital care for people with intellectual disabilities by means of bottom-up exploration of action opportunities to take account of stakeholders' values in designing technology, shaping the context of use, and adjusting the behavior of users. Although part of the findings may be generalized, case-specific insights and a complementary top-down approach (eg, predefined ethical frameworks) are essential. The findings represent a part of an ethical discourse that requires follow-up to meet the dynamism of stakeholders' values and further develop and implement action opportunities to achieve socially desirable, ethically acceptable, and sustainable digital care that improves the lives of people with intellectual disabilities.

The impact of assistive living technology on perceived independence of people with a physical disability in executing daily activities: a systematic literature review.

PURPOSE: People with physical disabilities often require lifetime support and experience challenges to maintain or (re)define their level of independence. Assistive living technologies (ALT) are promising to increase independent living and execution of activities of daily living (ADL). This paper provides a systematic literature review that aims to analyse the present state of the literature about the impact of ALT on perceived independence of people with a physical disability receiving long-term care. MATERIALS AND METHODS: Databases Embase, Medline, and Web of Science were searched for eligible studies from 2010 or later. RESULTS: Nine studies were included, of which seven qualitative, one quantitative, and one mixed methods. Quality was generally high. ALT enabled participants to execute ADL. We found six themes for the impact of ALT on perceived independence: feeling enabled, choice and control, feeling secure, time alone, feeling less needy, and participation. CONCLUSIONS: ALT appears to impact perceived independence in many ways, exceeding merely the executional aspect of independence. Existing research is limited and quite one-sided. More large-scale studies are needed in order to inform care organisations how to implement ALT, especially considering societal developments and challenges impacting long-term care.IMPLICATIONS FOR REHABILITATIONPeople with a physical disability receiving long-term care experience that assistive living technology impacted their independence.Their independence is increased by making them feel enabled, secure, and less needy and increasing their choice and control, time alone, and participation.Most studies focused on the use of environmental control systems by people with spinal cord injury.More research is needed to evaluate long-term effects of diverse assistive living technologies used by people with a physical disability receiving long-term care.

Smart Continence Care for People With Profound Intellectual and Multiple Disabilities: Protocol for a Cluster Randomized Trial and Trial-Based Economic Evaluation.

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) cannot communicate the need to change their incontinence products. The smart continence care (SCC) product Abena Nova signals caregivers when change is needed. This provides the opportunity for more person-centered care, increased quality of life, and a decreased number of leakages. However, there is a need for evidence of the effectiveness and cost-effectiveness of such technology compared with regular continence care (RCC) for people with PIMD. OBJECTIVE: This paper presents the research protocol for an effectiveness and cost-effectiveness study with people with PIMD living in long-term care facilities in the Netherlands. METHODS: A cluster randomized trial will be conducted in 3 consecutive waves across 6 long-term care providers for people with disabilities and 160 participants with PIMD. Long-term care providers are randomized at a 1:1 ratio, resulting in an intervention group and a group continuing RCC. The intervention group will receive implementation guidance and use SCC for 3 months; the other group will continue their RCC as usual and then switch to SCC. This study consists of three components: effectiveness study, economic evaluation, and process evaluation. The primary outcome will be a change in the number of leakages. The secondary outcomes are quality of life, the difference in the number of changes, the work perception of caregivers, cost-effectiveness, and cost utility. Data collection will occur at T0 (baseline), T1 (6 weeks), T2 (12 weeks), and T3 (9-month follow-up) for the first 2 intervention groups. An intention-to-treat analysis will be performed. The economic evaluation will be conducted alongside the trial from the societal and long-term care provider perspectives. Qualitative data collection through interviews and field notes will complement these quantitative results and provide input for the process evaluation. RESULTS: This research was funded in December 2019 by ZonMw, the Netherlands Organization for Health Research and Development. As of June 2022, we enrolled 118 of the 160 participants. The enrollment of participants will continue in the third and fourth quarters of 2022. CONCLUSIONS: This study will provide insights into the effectiveness and cost-effectiveness of SCC for people with PIMD, allowing long-term care providers to make informed decisions about implementing such a technology. This is the first time that such a large-scale study is being conducted for people with PIMD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481840; https://clinicaltrials.gov/ct2/show/NCT05481840. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42555.

Experiences of Persons With Executive Dysfunction in Disability Care Using a Social Robot to Execute Daily Tasks and Increase the Feeling of Independence: Multiple-Case Study.

BACKGROUND: Executive functions are essential for independently navigating nearly all of our daily activities. Executive dysfunction often occurs as a result of a neurodevelopmental disorder. Persons with executive dysfunction experience challenges regarding independent execution of daily tasks. Social robots might support persons with executive dysfunction to execute daily tasks and promote their feeling of independence. OBJECTIVE: This study aimed to study the impact of interacting with social robot Tessa on goal attainment in the execution of daily tasks and perceived independence of persons with executive dysfunction. METHODS: In this multiple-case study, 18 participant-caregiver couples were followed up while using Tessa in the home environment for 3 months. Goal attainment on independently performing a self-determined goal was measured by the Goal Attainment Scale, and participant-caregiver couples were interviewed about their experience with their interaction with Tessa and how they perceived Tessa's impact on their independence. RESULTS: In total, 11 (61%) participants reached their goal after 6 weeks and maintained their goal after 3 months. During the study period, 2 participant-caregiver couples withdrew because of mismatch with Tessa. Participants set goals in the following domains: execution of household tasks; intake of food, water, or medication; being ready in time for an appointment; going to bed or getting out of bed on time; personal care; and exercise. Participants perceived that Tessa increased the feeling of independence by generating more structure, stimulation, and self-direction. Participant-caregiver couples reported that the auditive information provided by Tessa was more effective in coping with executive dysfunction compared to their initial approaches using visual information, and the use of Tessa had a positive impact on their relationship. CONCLUSIONS: This study paid ample time and attention to the implementation of a social robot in daily care practice. The encouraging findings support the use of social robot Tessa for the execution of daily tasks and increasing independence of persons with executive dysfunction in disability care.

Comparing a ses-sensitive and an all-ses implementation strategy to improve participation rates of patients with a lower socioeconomic background in a web-based intervention for depressive complaints: a cluster randomised trial in primary care.

BACKGROUND: Depression is a major public health concern, which is most pronounced in population segments with a lower social-economic status (SES). E-health interventions for depressive complaints are proven to be effective, but their reach needs to be improved, especially among people with a lower socioeconomic status (SES). Implementing e-health interventions in the primary care setting with SES-sensitive guidance from General Practice nurses (GP nurses) may be a useful strategy to increase the reach of e-health in lower SES groups. We implemented an evidence-based online intervention that targets depressive complaints in primary care. METHODS: A pragmatic cluster-randomised trial was conducted in two parallel groups where a SES sensitive (SES-sens) implementation strategy with additional face-to-face guidance by GP nurses was compared to an all-SES implementation strategy. The primary outcome was the percentage of lower SES participants in either condition. Participation was defined as completing at least 1 face-to-face session and 2 online exercises. Participation rates were evaluated using logistic mixed modelling. RESULTS: In both conditions, the participation rates of lower SES participants were quite high, but were notably lower in the SES-sens implementation condition (44%) than in the all-SES implementation condition (58%). This unexpected outcome remained statistically significant even after adjusting for potential confounders between the conditions (Odds Ratio 0.43, 95%-CI 0.22 to 0.81). Less guidance was provided by the GP nurses in the SES-sens group, contrary to the implementation instructions. CONCLUSIONS: From a public health point of view, it is good news that a substantial number of primary care patients with a lower SES level used the implemented e-health intervention. It is also positive that an all-SES implementation strategy performed well, and even outperformed a SES-sensitive strategy. However, this was an unexpected finding, warranting further research into tailoring implementation strategies of e-health interventions towards specific target groups in the primary care setting. TRIAL REGISTRATION: Netherlands Trial Register, identifier: NL6595 , registered on 12 November 2017.

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Smoking Cessation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial.

BACKGROUND: Smoking cessation (SC) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. OBJECTIVE: This study aims to evaluate the effectiveness, cost-effectiveness, and cost-utility of a digital interactive SC intervention compared with a noninteractive web-based information brochure for cancer survivors. METHODS: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months. The study was conducted in the Netherlands over the internet from November 2016 to September 2019. The participants were Dutch adult smoking cancer survivors with the intention to quit smoking. In total, 165 participants were included and analyzed: 83 (50.3%) in the MyCourse group and 82 (49.7%) in the control group. In the intervention group, participants had access to a newly developed, digital, minimally guided SC intervention (MyCourse-Quit Smoking). Control group participants received a noninteractive web-based information brochure on SC. Both groups received unrestricted access to usual care. The primary outcome was self-reported 7-day smoking abstinence at the 6-month follow-up. Secondary outcomes were quality-adjusted life years gained, number of cigarettes smoked, nicotine dependence, and treatment satisfaction. For the health economic evaluation, intervention costs, health care costs, and costs stemming from productivity losses were assessed over a 12-month horizon. RESULTS: At the 6-month follow-up, the quit rates were 28% (23/83) and 26% (21/82) in the MyCourse and control groups, respectively (odds ratio 0.47, 95% CI 0.03-7.86; P=.60). In both groups, nicotine dependence scores were reduced at 12 months, and the number of smoked cigarettes was reduced by approximately half. The number of cigarettes decreased more over time, and the MyCourse group demonstrated a significantly greater reduction at the 12-month follow-up (incidence rate ratio 0.87; 95% CI 0.76-1.00; P=.04). Intervention costs were estimated at US $193 per participant for the MyCourse group and US $74 for the control group. The mean per-participant societal costs were US $25,329 (SD US $29,137) and US $21,836 (SD US $25,792), respectively. In the cost-utility analysis, MyCourse was not preferred over the control group from a societal perspective. With smoking behavior as the outcome, the MyCourse group led to marginally better results per reduced pack-year against higher societal costs, with a mean incremental cost-effectiveness ratio of US $52,067 (95% CI US $32,515-US $81,346). CONCLUSIONS: At 6 months, there was no evidence of a differential effect on cessation rates; in both groups, approximately a quarter of the cancer survivors quit smoking and their number of cigarettes smoked was reduced by half. At 12 months, the MyCourse intervention led to a greater reduction in the number of smoked cigarettes, albeit at higher costs than for the control group. No evidence was found for a differential effect on quality-adjusted life years. TRIAL REGISTRATION: The Netherlands Trial Register NTR6011; https://www.trialregister.nl/trial/5434. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4206-z.

Effectiveness, Cost-effectiveness, and Cost-Utility of a Digital Alcohol Moderation Intervention for Cancer Survivors: Health Economic Evaluation and Outcomes of a Pragmatic Randomized Controlled Trial.

BACKGROUND: Alcohol moderation (AM) interventions may contribute to better treatment outcomes and the general well-being of cancer survivors. OBJECTIVE: This study evaluates the effectiveness, cost-effectiveness, and cost-utility of MyCourse, a digital AM intervention, compared with a noninteractive digital information brochure for cancer survivors. METHODS: A health economic evaluation alongside a pragmatic 2-arm parallel-group randomized controlled trial was conducted with follow-ups at 3, 6, and 12 months after randomization. The study was conducted on the web in the Netherlands from 2016 to 2019. Participants were adult 10-year cancer survivors drinking over the Dutch-recommended drinking guidelines (≤7 standard units [10 g of alcohol] per week) with the intention to moderate or quit drinking. Overall, 103 participants were randomized and analyzed: 53 (51.5%) in the MyCourse group and 50 (48.5%) in the control group. In the MyCourse group, participants had access to a newly developed, digital, minimally guided AM intervention, MyCourse-Moderate Drinking. The primary outcome was the self-reported number of standard drinks (10 g of ethanol) consumed in the past 7 days at the 6-month follow-up. The secondary outcome measures were alcohol-related problems as measured by the Alcohol Use Disorders Identification Test (AUDIT) and treatment satisfaction. For the health economic evaluation, health care costs, costs because of productivity losses, and intervention costs were assessed over a 12-month horizon. RESULTS: Alcohol use at the 6-month follow-up decreased by 38% in the MyCourse group and by 33% in the control group. No difference in 7-day alcohol use was found between the groups (B=2.1, 95% CI -7.6 to 3.1; P=.22) at any of the follow-ups. AUDIT scores for alcohol-related problems decreased over time in both groups, showing no significant difference between the groups (Cohen d=0.3, 95% CI -0.1 to 0.6; P=.21). Intervention costs per participant were estimated at US $279 for the MyCourse group and US $74 for the control group. The mean societal costs were US $18,092 (SD 25,662) and US $23,496 (SD 34,327), respectively. The MyCourse group led to fewer gained quality-adjusted life years at lower societal costs in the cost-utility analysis. In the cost-effectiveness analysis, the MyCourse group led to a larger reduction in drinking units over time at lower societal costs (incremental cost-effectiveness ratio per reduced drink: US $ -1158, 95% CI -1609 to -781). CONCLUSIONS: At 6 months, alcohol use was reduced by approximately one-third in both groups, with no significant differences between the digital intervention MyCourse and a noninteractive web-based brochure. At 12 months, cost-effectiveness analyses showed that MyCourse led to a larger reduction in drinking units over time, at lower societal costs. The MyCourse group led to marginally fewer gained quality-adjusted life years, also at lower societal costs. TRIAL REGISTRATION: Netherlands Trial Register NTR6010; https://www.trialregister.nl/trial/5433. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12885-018-4206-z.

Cancer survivors' views on digital support for smoking cessation and alcohol moderation: a survey and qualitative study.

BACKGROUND: Digital interventions may provide low-threshold support for smoking cessation (SC) and alcohol moderation (AM) to the growing population of cancer survivors. The objective was to explore preconditions of successful AM and SC digital interventions for cancer survivors. METHODS: Using a multi-method approach we conducted a survey (n = 240), a qualitative study consisting of four focus groups (n = 15) and semi-structured interviews with Dutch cancer survivors (n = 8). To help interpretation of our results we interviewed experts in the field of eHealth and cancer survivors (n = 6) and we organized an expert meeting (n = 7). Qualitative data were analysed using the Framework approach and were double-coded by two coders. RESULTS: Survey results show the majority of drinkers had not previously considered AM (n = 158, 84.9%), often because they deemed their alcohol use to be non-problematic. All current smokers in the survey had considered SC before. In focus groups and interviews it became clear that SC efforts did not always stem from their own willingness to quit smoking, but originated from a wish to please their social environment. Main themes to be addressed in digital SC and AM that emerged from the interviews and focus groups, centred on the different ways of identification as cancer survivors, need for autonomy, differential beliefs about SC and AM, and the importance of a positive, non-patronizing tone-of-voice. Several specific preferences for digital interventions were formulated, although some cancer survivors prefer no support or face-to-face contact. CONCLUSIONS: Cancer survivors are a diverse group with diverse preferences for AM and SC support. Digital AM and SC interventions for cancer survivors are perceived to be of value by some, especially when they incorporate a positive, non-judgemental and non-patronizing tone-of-voice, address concerns specifically relevant to cancer survivors, offer possibilities for personalization, and emphasize autonomy throughout. To encourage AM specifically, problem recognition and awareness of the health benefits of AM should be improved.

Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial.

BACKGROUND: Depression is a major public health concern. E-health interventions for preventing and reducing depressive complaints have proven to be effective, and have the potential to make (mental) health care more accessible and efficient. However, the reach of these interventions needs to be improved, especially among people with a lower socioeconomic status (SES). Stimulating and supporting implementation of e-health in primary care, and offering guidance from general practice nurses (GP nurses) may be important strategies to achieve this. METHODS/DESIGN: The online 'Complaint Directed Mini-Interventions' (CDMIs) for stress, sleep and worry complaints, which were found to be (cost-)effective in a self-guided format, will be implemented in the primary care setting using a blended care format (i.e. combining e-health with face-to-face sessions) with minimal guidance provided by the GP nurse. The main aim is to evaluate whether a SES-sensitive implementation strategy improves the participation rate (i.e. reach) of lower-SES patients in the blended online CDMIs as compared to a regular implementation strategy in a cluster randomised controlled trial. Randomisation will occur at the level of the GP nurse, and 228 patients will be included in the study. The primary outcome is the participation rate (completing at least one face-to-face session and two online exercises) of the lower-SES target group. It is hypothesised that this percentage will be higher in the SES-sensitive group as compared to the regular group. Secondary objectives are to evaluate the implementation process, to monitor and evaluate psychological complaints (depression, sleep, stress, worry and anxiety) and well-being over time. Patient assessments will take place at baseline, 3 and 12 months post baseline. DISCUSSION: This study should contribute to our knowledge of reaching the lower-SES groups with a brief and complaint-specific blended approach for depressive complaints in primary care. It should also further our knowledge on successful strategies to implement depression prevention in primary care. TRIAL REGISTRATION: Netherlands Trial Register, ID: NL6595. Registered on 12 November 2017.

The effectiveness of distance-based interventions for smoking cessation and alcohol moderation among cancer survivors: A meta-analysis.

OBJECTIVE: The objective of this study is to evaluate current evidence for the effectiveness of distance-based interventions to support smoking cessation (SC) or alcohol moderation (AM) among cancer survivors. Secondary, differences in effectiveness are explored regarding multibehaviour interventions versus single-behaviour interventions targeting SC or AM only. METHODS: A systematic search of PubMed, PsycINFO, Web of Science, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials was conducted. Intervention studies with and without control groups and randomized controlled trials were included. Random effects meta-analyses were conducted for the main outcomes: SC and AM rates at the follow-up closest to 6 months. Using subgroup analyses and meta-regression, effectiveness of single-behaviour versus multibehaviour interventions was evaluated. RESULTS: A total of 17 studies with 3796 participants; nine studies on SC only, eight studies on multibehaviour interventions including an SC or AM module, and no studies on AM only were included. All studies had at least some concerns regarding bias. Distance-based SC interventions led to higher cessation rates than control conditions (10 studies, odds ratio [OR] = 1.56; 95% CI, 1.13-2.15, P = .007). Single-behaviour SC interventions reduced smoking rates compared with baseline (risk difference [RD] = 0.29; 95% CI, 0.19-0.39, P < .0001), but multibehaviour interventions did not (RD = 0.13; 95% CI, -0.05 to 0.31, P = 0.15). There was insufficient evidence that distance-based multibehaviour interventions reduced alcohol use compared with controls (three studies, standardized mean difference [SMD] = 0.12; 95% CI, -0.08 to 0.31, P = .24). CONCLUSIONS: Distance-based SC interventions are effective in supporting SC among cancer survivors. Single-behaviour SC interventions appear more effective than multibehaviour interventions. No evidence was found for the effectiveness of distance-based AM interventions for cancer survivors.

Effectiveness and treatment moderators of internet interventions for adult problem drinking: An individual patient data meta-analysis of 19 randomised controlled trials.

BACKGROUND: Face-to-face brief interventions for problem drinking are effective, but they have found limited implementation in routine care and the community. Internet-based interventions could overcome this treatment gap. We investigated effectiveness and moderators of treatment outcomes in internet-based interventions for adult problem drinking (iAIs). METHODS AND FINDINGS: Systematic searches were performed in medical and psychological databases to 31 December 2016. A one-stage individual patient data meta-analysis (IPDMA) was conducted with a linear mixed model complete-case approach, using baseline and first follow-up data. The primary outcome measure was mean weekly alcohol consumption in standard units (SUs, 10 grams of ethanol). Secondary outcome was treatment response (TR), defined as less than 14/21 SUs for women/men weekly. Putative participant, intervention, and study moderators were included. Robustness was verified in three sensitivity analyses: a two-stage IPDMA, a one-stage IPDMA using multiple imputation, and a missing-not-at-random (MNAR) analysis. We obtained baseline data for 14,198 adult participants (19 randomised controlled trials [RCTs], mean age 40.7 [SD = 13.2], 47.6% women). Their baseline mean weekly alcohol consumption was 38.1 SUs (SD = 26.9). Most were regular problem drinkers (80.1%, SUs 44.7, SD = 26.4) and 19.9% (SUs 11.9, SD = 4.1) were binge-only drinkers. About one third were heavy drinkers, meaning that women/men consumed, respectively, more than 35/50 SUs of alcohol at baseline (34.2%, SUs 65.9, SD = 27.1). Post-intervention data were available for 8,095 participants. Compared with controls, iAI participants showed a greater mean weekly decrease at follow-up of 5.02 SUs (95% CI -7.57 to -2.48, p < 0.001) and a higher rate of TR (odds ratio [OR] 2.20, 95% CI 1.63-2.95, p < 0.001, number needed to treat [NNT] = 4.15, 95% CI 3.06-6.62). Persons above age 55 showed higher TR than their younger counterparts (OR = 1.66, 95% CI 1.21-2.27, p = 0.002). Drinking profiles were not significantly associated with treatment outcomes. Human-supported interventions were superior to fully automated ones on both outcome measures (comparative reduction: -6.78 SUs, 95% CI -12.11 to -1.45, p = 0.013; TR: OR = 2.23, 95% CI 1.22-4.08, p = 0.009). Participants treated in iAIs based on personalised normative feedback (PNF) alone were significantly less likely to sustain low-risk drinking at follow-up than those in iAIs based on integrated therapeutic principles (OR = 0.52, 95% CI 0.29-0.93, p = 0.029). The use of waitlist control in RCTs was associated with significantly better treatment outcomes than the use of other types of control (comparative reduction: -9.27 SUs, 95% CI -13.97 to -4.57, p < 0.001; TR: OR = 3.74, 95% CI 2.13-6.53, p < 0.001). The overall quality of the RCTs was high; a major limitation included high study dropout (43%). Sensitivity analyses confirmed the robustness of our primary analyses. CONCLUSION: To our knowledge, this is the first IPDMA on internet-based interventions that has shown them to be effective in curbing various patterns of adult problem drinking in both community and healthcare settings. Waitlist control may be conducive to inflation of treatment outcomes.

Internet-based self-help smoking cessation and alcohol moderation interventions for cancer survivors: a study protocol of two RCTs.

BACKGROUND: Brief interventions for smoking cessation and alcohol moderation may contribute considerably to the prevention of cancer among populations at risk, such as cancer survivors, in addition to improving their general wellbeing. There is accumulating evidence for the effectiveness of internet-based brief health behaviour interventions. The objective of this study is to assess the effectiveness, patient-level cost-effectiveness and cost-utility of two new online theory-based self-help interventions among adult cancer survivors in the Netherlands. One of the interventions focuses on alcohol moderation, the other on smoking cessation. Both interventions are tailored to cancer survivors. METHODS: Effectiveness will be assessed in two separate, nearly identical 2-armed RCTs: alcohol moderation (AM RCT) and smoking cessation (SC RCT). Participants are randomly allocated to either the intervention groups or the control groups. In the intervention groups, participants have access to one of the newly developed interventions. In the control groups, participants receive an online static information brochure on alcohol (AM RCT) or smoking (SC RCT). Main study outcome parameters are the number of drinks post-randomisation (AM RCT) and tobacco abstinence (SC RCT). In addition, cost-data and possible effect moderators and mediators will be assessed. Both treatments are internet-based minimally guided self-help interventions: MyCourse - Moderate Drinking (in Dutch: MijnKoers - Minderen met Drinken) and MyCourse - Quit Smoking (MijnKoers - Stoppen met Roken). They are based on cognitive behaviour therapy (CBT), motivational interviewing (MI) and acceptance and commitment therapy (ACT). Both interventions are optimized in collaboration with the target population of cancer survivors in focus groups and interviews, and in collaboration with several experts on eHealth, smoking cessation, alcohol misuse and cancer survivorship. DISCUSSION: The present study will add to scientific knowledge on the (cost-)effectiveness of internet-based self-help interventions to aid in smoking cessation or alcohol moderation, working mechanisms and impact on quality of life of cancer survivors. If found effective, these interventions can contribute to providing evidence-based psychosocial oncology care to a growing population of cancer survivors. TRIAL REGISTRATION: Trials are prospectively registered in The Netherlands Trial Register (NTR): NTR6011 (SC RCT), NTR6010 (AM RCT) on 1 September 2016.

Return-to-work intervention versus usual care for sick-listed employees: health-economic investment appraisal alongside a cluster randomised trial.

OBJECTIVE: To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. DESIGN: A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. SETTING: Occupational health care in the Netherlands. PARTICIPANTS: Employees from small-sized and medium-sized companies (≥18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. INTERVENTIONS: In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. OUTCOMES MEASURES: Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. RESULTS: From the employer's perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee's perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier's perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. CONCLUSIONS: The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very precise estimates and real benefits could vary considerably. TRIAL REGISTRATION: NTR2108; Results.

Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

BACKGROUND: Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry. OBJECTIVE: The aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group. METHODS: A two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models. RESULTS: In total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period (median 3, range 0-166). After 3 months, there was a significant reduction in depressive symptomatology for participants in the intervention group compared to participants in the wait-list control group (reduction in depression: mean -4.47, 95% CI -6.54 to -2.40; Cohen d=-0.70). Furthermore, significant effects were observed for sleep problems, worry, anxiety, and well-being, with effect sizes ranging from -0.29 to -0.40. The intervention did not significantly reduce stress. At 6-month follow-up, the improvements in the intervention group were generally sustained. CONCLUSIONS: This study shows that the online self-help CDMIs have a positive impact on various mental health outcomes. Future research should focus on which specific strategies may boost adherence, and increase the reach of the CDMIs among people with low socioeconomic status. CLINICALTRIAL: Netherlands Trial Register (NTR): NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).

An early intervention to promote well-being and flourishing and reduce anxiety and depression: A randomized controlled trial.

BACKGROUND: There is growing evidence that fostering mental well-being and flourishing might effectively prevent mental disorders. In this study, we examined whether a 9-week comprehensive positive self-help intervention with email support (TL-E) was effective in enhancing well-being and flourishing and decreasing anxiety and depressive symptoms in a non-clinical sample. METHODS: A total of 275 participants with low or moderate well-being (mean age = 48 years, 86% female) were randomly assigned to a TL-E (n = 137) or wait-list control group (WL; n = 138). Participants completed online self-reporting questionnaires at baseline and at 3, 6 and 12 months. RESULTS: Repeated measure analyses revealed significant more improvement on mental well-being (F = 42.00, p ≤ 0.001, d = 0.66, 95% CI = 0.42-0.90), anxiety (F = 21.65, p ≤ 0.001, d = 0.63, 95% CI = 0.39-0.87) and depression (F = 13.62, p ≤ 0.001, d = 0.43, 95% CI = 0.19-0.67) in the TL-E group versus the WL group. The proportion of flourishing in the TL-E group increased from 7 to 30% after 3 months (NNT = 5.46) and to 34% after 6 months (NNT = 5.25). All within group effects were maintained up to 12 months. We found no meaningful dose-response relationship for adherence, nor a clear moderator pattern. LIMITATIONS: It is unknown whether results were influenced by the email support that accompanied the self-help intervention since TL-E was only compared to a wait-list condition. The generalizability of the findings is limited by the self-selected sample of mainly higher-educated women. CONCLUSION: A guided positive self-help intervention might be considered as a new mental health promotion strategy because it has the potential to improve well-being up to the status of flourishing mental health, and to decrease anxiety and depressive symptomatology.

Drinker prototype alteration and cue reminders as strategies in a tailored web-based intervention reducing adults' alcohol consumption: randomized controlled trial.

BACKGROUND: Excessive alcohol use is a prevalent and worldwide problem. Excessive drinking causes a significant burden of disease and is associated with both morbidity and excess mortality. Prototype alteration and provision of a cue reminder could be useful strategies to enhance the effectiveness of online tailored interventions for excessive drinking. OBJECTIVE: Through a Web-based randomized controlled trial, 2 strategies (ie, prototype alteration and cue reminders) within an existing online personalized feedback intervention (Drinktest) aimed to reduce adults' excessive drinking. It was expected that both strategies would add to Drinktest and would result in reductions in alcohol consumption by intrinsic motivation and the seizure of opportunities to act. METHODS: Participants were recruited online and through printed materials. Excessive drinking adults (N=2634) were randomly assigned to 4 conditions: original Drinktest, Drinktest plus prototype alteration, Drinktest plus cue reminder, and Drinktest plus prototype alteration and cue reminder. Evaluation took place at 1-month posttest and 6-month follow-up. Differences in drinking behavior, intentions, and behavioral willingness (ie, primary outcomes) were assessed by means of longitudinal multilevel analyses using a last observation carried forward method. Measures were based on self-reports. RESULTS: All conditions showed reductions in drinking behavior and willingness to drink, and increased intentions to reduce drinking. Prototype alteration (B=-0.15, P<.05) and cue reminder usage (B=-0.15, P<.05) were both more effective in reducing alcohol consumption than when these strategies were not provided. Combining the strategies did not produce a synergistic effect. No differences across conditions were found regarding intentions or willingness. CONCLUSIONS: Although individuals' awareness of their cue was reasonable, their reported alcohol consumption was nevertheless reduced. Individuals appeared to distance their self-image from heavier drinking prototypes. Thus, prototype alteration and cue reminder usage may be feasible and simple intervention strategies to promote reductions in alcohol consumption among adults, with an effect up to 6 months. TRIAL REGISTRATION: Nederlands Trial Register (NTR): 4169; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4169 (Archived by WebCite at http://www.webcitation.org/6VD2jnxmB).

The mental health of visitors of web-based support forums for bereaved by suicide.

BACKGROUND: Persons bereaved by suicide are reluctant to ask for social support when they experience feelings of guilt and blame. A web-based peer forum may provide a safe and anonymous place for mutual support. AIMS: This study examined the mental health changes of visitors of two online support forums for persons bereaved by suicide and their experiences with the forum over 1 year. METHOD: Visitors of two forums completed self-report measures at baseline and at 6 and 12 months' follow-up. Repeated measures analyses were used to study changes in well-being, depressive symptoms, and complicated grief. Additionally, participants were interviewed about their experiences with the forum. RESULTS: The 270 participants were mostly female, low in well-being, with high levels of depressive symptoms and complicated grief. Suicidal risk was high for 5.9%. At 12 months, there were small to medium-sized significant improvements in well-being and depressive symptoms (p < .001) and nearly as much for grief (p = .08). About two thirds reported benefit from visiting the forum. Because of the pre-post design we cannot determine whether a causal relationship exists between the form and changes in mental health. CONCLUSION: After 1 year some positive changes but a large group was still struggling with their mental health. Interviews indicate that the forum was valued for finding recognition.

[E-health within the Dutch mental health services: what is the current situation?]. / E-health in de GGZ: hoe staat het daar nu mee?

The 'e-mental health' currently available, which also covers m-health and i-health, varies from psycho-education and self-tests to self-help, treatment and contact with fellow sufferers. Many programs are based on cognitive behavioural therapy, but other types of therapy are also used. Research shows that online programs for depression, alcohol problems and anxiety can reduce these symptoms and can be cost effective. This applies to both self-help and treatment programs. Many e-programs in the Netherlands have been developed for the Dutch Association of Mental Health and Addiction Care (GGZ) and for treatment of addiction problems. One problem with e-mental-health is that provision is fragmented, and there is no national overview, while insight into quality is important for patients and professionals. The quality hallmark 'Onlinehulpstempel.nl' ('Online help hallmark') provides this insight. The use of e-mental-health within Dutch healthcare services is still in its infancy. New financing methods are stimulating general practitioners to use it. The consolidation of online and face-to-face care ('blended e-health') provides an opportunity for patients and GGZ support personnel within general practice to start to use e-health.