Comparing the Effectiveness of the Blended Delivery Mode With the Face-to-Face Delivery Mode of Smoking Cessation Treatment: Noninferiority Randomized Controlled Trial.

BACKGROUND: Tobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment. OBJECTIVE: The primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates. METHODS: This study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide-validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation. RESULTS: None of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive. CONCLUSIONS: In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions. TRIAL REGISTRATION: Netherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-doi.org/10.1186/s12889-016-3851-x.

Augmenting outpatient alcohol treatment as usual with online approach bias modification training: A double-blind randomized controlled trial.

Previous research shows that automatic tendency to approach alcohol plays a causal role in problematic alcohol use and can be retrained by Approach Bias Modification (ApBM). ApBM has been shown to be effective for patients diagnosed with alcohol use disorder (AUD) in inpatient treatment. This study aimed to investigate the effectiveness of adding an online ApBM to treatment as usual (TAU) in an outpatient setting compared to receiving TAU with an online placebo training. 139 AUD patients receiving face-to-face or online treatment as usual (TAU) participated in the study. The patients were randomized to an active or placebo version of 8 sessions of online ApBM over a 5-week period. The weekly consumed standard units of alcohol (primary outcome) was measured at pre-and post-training, 3 and 6 months follow-up. Approach tendency was measured pre-and-post ApBM training. No additional effect of ApBM was found on alcohol intake, nor other outcomes such as craving, depression, anxiety, or stress. A significant reduction of the alcohol approach bias was found. This research showed that approach bias retraining in AUD patients in an outpatient treatment setting reduces the tendency to approach alcohol, but this training effect does not translate into a significant difference in alcohol reduction between groups. Explanations for the lack of effects of ApBM on alcohol consumption are treatment goal and severity of AUD. Future ApBM research should target outpatients with an abstinence goal and offer alternative, more user-friendly modes of delivering ApBM training.

Intention of healthcare providers to use video-communication in terminal care: a cross-sectional study.

BACKGROUND: Interdisciplinary collaboration between healthcare providers with regard to consultation, transfer and advice in terminal care is both important and challenging. The use of video communication in terminal care is low while in first-line healthcare it has the potential to improve quality of care, as it allows healthcare providers to assess the clinical situation in real time and determine collectively what care is needed. The aim of the present study is to explore the intention to use video communication by healthcare providers in interprofessional terminal care and predictors herein. METHODS: In this cross-sectional study, an online survey was used to explore the intention to use video communication. The survey was sent to first-line healthcare providers involved in terminal care (at home, in hospices and/ or nursing homes) and consisted of 39 questions regarding demographics, experience with video communication and constructs of intention to use (i.e. Outcome expectancy, Effort expectancy, Attitude, Social influence, Facilitating conditions, Anxiety, Self-efficacy and Personal innovativeness) based on the Unified Theory of Acceptance and Use of Technology and Diffusion of Innovation Theory. Descriptive statistics were used to analyze demographics and experiences with video communication. A multiple linear regression analysis was performed to give insight in the intention to use video communication and predictors herein. RESULTS: 90 respondents were included in the analysis.65 (72%) respondents had experience with video communication within their profession, although only 15 respondents (17%) used it in terminal care. In general, healthcare providers intended to use video communication in terminal care (Mean (M) = 3.6; Standard Deviation (SD) = .88). The regression model was significant (F = 9.809, p-value<.001) and explained 44% of the variance in intention to use video communication, with 'Outcome expectancy' (beta .420, p < .001) and 'Social influence' (beta .266, p = .004) as significant predictors. CONCLUSIONS: Healthcare providers have in general the intention to use video communication in interprofessional terminal care. However, their actual use in terminal care is low. 'Outcome expectancy' and 'Social influence' seem to be important predictors for intention to use video communication. This implicates the importance of informing healthcare providers, and their colleagues and significant others, about the usefulness and efficiency of video communication.

An ideographic study into physiology, alcohol craving and lapses during one hundred days of daily life monitoring.

Introduction: Alcohol craving is a highly challenging obstacle to achieve long-term abstinence. Making alcohol use disorder patients timely aware of high-risk craving situations may protect them against relapse by prompting them to mobilize their coping resources. Current advances in wearable and smart-phone technology provide novel opportunities for the development of detecting these situations of heightened risk of craving, by enabling continuous tracking of fluctuations in psychological and physiological parameters. The present study therefore aims to determine the association between self-reported craving and relapses, and between heightened physiological activity. Specifically, we measured cardiovascular and electrodermal activity, and self-reported craving during one hundred days in the daily life of people trying to recover from alcoholism. The secondary aim is to study whether the association between physiology and craving can be strengthened by the inclusion of context related psychological parameters. Methods: An intensive repeated and continuous measures in naturalistic settings case-study design was employed. Ten participants were monitored with wearable bio-sensors and answered multiple questions every three hours on a smartphone app about craving, lapsing and multiple evidence based contextual variables. The association between physiology, craving and lapses was explored using Matthews correlation coefficients both with a current and 3 h lagged design. The contextual variables were included in a decision tree together with the physiological parameters to explore the added effect on the correlation of these contextual variables. Results: The association between lapses and craving was highly different across individuals, varying between a weak to a strong association. The association between cardiovascular activity and heightened self-reported craving was negligible to weak, however with a high specificity, meaning that most craving events were accompanied by increase heart rate. However, the association between electrodermal activity and craving was lower than with cardiovascular activity for most participants, both prior (lagged) and during craving. For two of the participants the association between physiology and craving improved by adding contextual variables, however, precision was too low. Conclusions: People differ strongly in their bodily reactions and psychological experiences during the first months of their addiction treatment. No individual in our study had unique one-to-one mappings between on the one hand physiological or psychological precursors, and on the other hand craving and (re)lapses. Therefore, detecting high risk craving situations with both physiological activity measured with wearables and psychological precursors to alert people specifically for an imminent (re)lapse, does not seem viable on the basis of the current results. We do see an added benefit of using physiology during treatment, as physiology can help start the conversation about possible high risk craving situations during that week. This would also help the counselor to gain added insights into the fluctuating states of the clients, and help to ameliorate the recall bias of clients. The present study showed the possibility and paved the way for future intensive longitudinal designs integrating both physiological, psychological and contextual factors during the challenging and lengthy recovery from addiction.

Long-term effectiveness of web-based cognitive behavioral therapy for patients with eating disorders.

PURPOSE: To evaluate the long-term effectiveness of a web-based therapist-delivered cognitive behavioral therapy (CBT) for patients with eating disorders (ED). METHODS: We used follow-up data from a randomized controlled trial that evaluated a web-based CBT on ED psychopathology and related health, compared to a waiting list control (WL) condition. As participants of the WL condition started the intervention after their waiting period, follow-up data included participants from both groups. The primary outcome was change from baseline, at 3, 6, and 12-month intervals in ED psychopathology, analyzed using mixed models for repeated measures. Secondary outcomes included body dissatisfaction, BMI, physical health, mental health, self-esteem, quality of life, and social functioning. RESULTS: The population comprised 212 participants in total, in three subgroups: bulimia nervosa (BN; n = 44), binge eating disorder (BED; n = 83), and ED not otherwise specified (EDNOS; n = 85). Treatment effects were sustained during follow-up, with generally large effect sizes for the reduction of ED psychopathology and body dissatisfaction, and small to moderate effect sizes for physical and mental health, self-esteem, social functioning, and quality of life. Most effects were found for all three subgroups, except for long-term improvements in self-esteem and quality of life among participants with BN and EDNOS. CONCLUSION: This study showed long-term sustainability of treatment effects up to 1-year post-treatment of a web-based therapist-delivered CBT for patients with various ED. LEVEL OF EVIDENCE: Level IV, evidence obtained from multiple time series analysis, with intervention. UNIQUE CLINICAL TRIAL NUMBER: NTR2415-Dutch Trial Registry ( http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2415 ).

Analysis of the Emails From the Dutch Web-Based Intervention "Alcohol de Baas": Assessment of Early Indications of Drop-Out in an Online Alcohol Abuse Intervention.

Nowadays, traditional forms of psychotherapy are increasingly complemented by online interactions between client and counselor. In (some) web-based psychotherapeutic interventions, meetings are exclusively online through asynchronous messages. As the active ingredients of therapy are included in the exchange of several emails, this verbal exchange contains a wealth of information about the psychotherapeutic change process. Unfortunately, drop-out-related issues are exacerbated online. We employed several machine learning models to find (early) signs of drop-out in the email data from the "Alcohol de Baas" intervention by Tactus. Our analyses indicate that the email texts contain information about drop-out, but as drop-out is a multidimensional construct, it remains a complex task to accurately predict who will drop out. Nevertheless, by taking this approach, we present insight into the possibilities of working with email data and present some preliminary findings (which stress the importance of a good working alliance between client and counselor, distinguish between formal and informal language, and highlight the importance of Tactus' internet forum).

Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.

BACKGROUND: Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator of treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to blended and face-to-face alone smoking cessation treatments with similar content and intensity. OBJECTIVE: The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment with adherence to a face-to-face treatment; (2) to compare adherence within the blended treatment to its face-to-face mode and web mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment. METHODS: We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic who were randomly assigned either to the blended smoking cessation treatment (n=130) or to a face-to-face treatment with identical components (n=162). For both treatments (blended and face-to-face) and for the two modes of delivery within the blended treatment (face-to-face vs web mode), adherence levels (ie, treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics. RESULTS: We found no significant difference in adherence between the blended and the face-to-face treatments. Participants in the blended treatment group spent an average of 246 minutes in treatment (median 106.7% of intended treatment time, IQR 150%-355%) and participants in the face-to-face group spent 238 minutes (median 103.3% of intended treatment time, IQR 150%-330%). Within the blended group, adherence to the face-to-face mode was twice as high as that to the web mode. Participants in the blended group spent an average of 198 minutes (SD 120) in face-to-face mode (152% of the intended treatment time) and 75 minutes (SD 53) in web mode (75% of the intended treatment time). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both the blended and face-to-face groups. For the face-to-face group, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (blended R2=0.049; face-to-face R2=0.076). Within the blended group, living without children predicted higher adherence to the face-to-face mode (R2=0.034), independent of age. Higher adherence to the web mode of the blended treatment was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting, and less health complaints (R2=0.164). CONCLUSIONS: This study represents one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher for the face-to-face mode than for the web mode. This supports the idea that in blended treatment, one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study suggests that other variables such as provider-related health system factors and time-varying patient characteristics should be explored in future research. TRIAL REGISTRATION: Netherlands Trial Register NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113.

Patients' User Experience of a Blended Face-to-Face and Web-Based Smoking Cessation Treatment: Qualitative Study.

BACKGROUND: Blended web-based and face-to-face (F2F) treatment is a promising electronic health service because the strengths of one mode of delivery should compensate for the weaknesses of the other. OBJECTIVE: The aim of this study was to explore this compensation by examining patients' user experience (UX) in a blended smoking cessation treatment (BSCT) in routine care. METHODS: Data on patients' UX were collected through in-depth interviews (n=10) at an outpatient smoking cessation clinic in the Netherlands. A content analysis of the semantic domains was used to analyze patients' UX. To describe the UX, the Hassenzahl UX model was applied, examining 4 of the 5 key elements of UX from a user's perspective: (1) patients' standards and expectations, (2) apparent character (pragmatic and hedonic attributes), (3) usage situation, and (4) consequences (appeal, emotions, and behavior). RESULTS: BSCT appeared to be a mostly positively experienced service. Patients had a positive-pragmatic standard and neutral-open expectation toward BSCT at the treatment start. The pragmatic attributes of the F2F sessions were mostly perceived as positive, whereas the pragmatic attributes of the web sessions were perceived as both positive and negative. For the hedonic attributes, there seemed to be a difference between the F2F and web sessions. Specifically, the hedonic attributes of the web sessions were experienced as mostly negative, whereas those of the F2F sessions were experienced as mostly positive. For the usage situation, the physical and social contexts were experienced positively, whereas the task and technical contexts were experienced negatively. Nevertheless, the consequential appeal of BSCT was positive. However, the consequential emotions and behavior varied, ultimately resulting in diverse combinations of consequential appeal, emotions, and behavior (positive, negative, and mixed). CONCLUSIONS: This study provided insights into the UX of a blended treatment, and the results support the expectation that in a blended treatment, the strengths of one mode of delivery may compensate for the weaknesses of the other. However, in this certain setting, this is mainly achieved in only one way: F2F sessions compensated for the weaknesses of the web sessions. As a practical conclusion, this may mean that the web sessions, supported by the strengths of the F2F sessions, offer an interesting approach for further improving the blended treatment. Our theoretical findings reflect the relevance of the aspects of hedonism, such as fun, joy, or happiness in the UX, which were not mentioned in relation to the web sessions and were only scarcely mentioned in relation to the F2F sessions. Future research should further investigate the role of hedonistic aspects in a blended treatment and whether increased enjoyment of a blended treatment could increase treatment adherence and, ultimately, effectiveness.

Alcohol Avoidance Training as a Mobile App for Problem Drinkers: Longitudinal Feasibility Study.

BACKGROUND: Alcohol use is associated with an automatic tendency to approach alcohol, and the retraining of this tendency (cognitive bias modification [CBM]) shows therapeutic promise in clinical settings. To improve access to training and to enhance participant engagement, a mobile version of alcohol avoidance training was developed. OBJECTIVE: The aims of this pilot study were to assess (1) adherence to a mobile health (mHealth) app; (2) changes in weekly alcohol use from before to after training; and (3) user experience with regard to the mHealth app. METHODS: A self-selected nonclinical sample of 1082 participants, who were experiencing problems associated with alcohol, signed up to use the alcohol avoidance training app Breindebaas for 3 weeks with at least two training sessions per week. In each training session, 100 pictures (50 of alcoholic beverages and 50 of nonalcoholic beverages) were presented consecutively in a random order at the center of a touchscreen. Alcoholic beverages were swiped upward (away from the body), whereas nonalcoholic beverages were swiped downward (toward the body). During approach responses, the picture size increased to mimic an approach movement, and conversely, during avoidance responses, the picture size decreased to mimic avoidance. At baseline, we assessed sociodemographic characteristics, alcohol consumption, alcohol-related problems, use of other substances, self-efficacy, and craving. After 3 weeks, 37.89% (410/1082) of the participants (posttest responders) completed an online questionnaire evaluating adherence, alcohol consumption, and user satisfaction. Three months later, 19.03% (206/1082) of the participants (follow-up responders) filled in a follow-up questionnaire examining adherence and alcohol consumption. RESULTS: The 410 posttest responders were older, were more commonly female, and had a higher education as compared with posttest dropouts. Among those who completed the study, 79.0% (324/410) were considered adherent as they completed four or more sessions, whereas 58.0% (238/410) performed the advised six or more training sessions. The study identified a significant reduction in alcohol consumption of 7.8 units per week after 3 weeks (95% CI 6.2-9.4, P<.001; n=410) and another reduction of 6.2 units at 3 months for follow-up responders (95% CI 3.7-8.7, P<.001; n=206). Posttest responders provided positive feedback regarding the fast-working, simple, and user-friendly design of the app. Almost half of the posttest responders reported gaining more control over their alcohol use. The repetitious and nonpersonalized nature of the intervention was suggested as a point for improvement. CONCLUSIONS: This is one of the first studies to employ alcohol avoidance training in a mobile app for problem drinkers. Preliminary findings suggest that a mobile CBM app fulfils a need for problem drinkers and may contribute to a reduction in alcohol use. Replicating these findings in a controlled study is warranted.

A standardized validity assessment protocol for physiological signals from wearable technology: Methodological underpinnings and an application to the E4 biosensor.

Wearable physiological measurement devices for ambulatory research with novel sensing technology are introduced with ever increasing frequency, requiring fast, standardized, and rigorous validation of the physiological signals measured by these devices and their derived parameters. At present, there is a lack of consensus on a standardized protocol or framework with which to test the validity of this new technology, leading to the use of various (often unfit) methods. This study introduces a comprehensive validity assessment protocol for physiological signals (electrodermal activity and cardiovascular activity) and investigates the validity of the E4 wearable (an example of such a new device) on the three levels proposed by the protocol: (1) the signal level, with a cross-correlation; (2) the parameter level, with Bland-Altman plots; and (3) the event level, with the detection of physiological changes due to external stressor levels via event difference plots. The results of the protocol show that the E4 wearable is valid for heart rate, RMSSD, and SD at the parameter and event levels, and for the total amplitude of skin conductance responses at the event level when studying strong sustained stressors. These findings are in line with the prior literature and demonstrate the applicability of the protocol. The validity assessment protocol proposed in this study provides a comprehensive, standardized, and feasible method for assessment of the quality of physiological data coming from new wearable (sensor) technology aimed at ambulatory research.

Online Therapy for Depressive Symptoms: An Evaluation of Counselor-Led and Peer-Supported Life Review Therapy.

Objectives: Life review therapy is recognized as an evidence-based treatment for depression in later life. The current article evaluates an online life review therapy in middle-aged and older persons, comparing a counselor-led to a peer-supported mode of delivery. Methods: A pilot randomized controlled trial (RCT) was carried out with 3 conditions and 4 measurement points: (a) online life review therapy with online counseling, (b) online life review therapy with online peer support, and (c) a waitlist control condition. A mixed methods study provided insight in the reach, adherence, effectiveness, user experiences, and acceptability. Results: Fifty-eight people were included in the study. The intervention reached a vulnerable group of mainly middle-aged, college-educated women. The pilot RCT on effectiveness showed that participants in all conditions improved significantly in depressive symptoms, engaged living, mastery, and vitality, but not in ego integrity and despair, social support, loneliness, and well-being. The adherence, user experience, and acceptability were better in the counselor condition than in the peer condition. No differences were found between middle-aged and older adults. Conclusion: Despite the nonsignificant effects, possibly due to the small sample size, online life review therapy might be a good method for alleviating depressive symptoms in people in their second half of life. Further research is needed, addressing how online life review is best offered.

Blended Smoking Cessation Treatment: Exploring Measurement, Levels, and Predictors of Adherence.

BACKGROUND: Blended face-to-face and Web-based treatment is a promising way to deliver cognitive behavioral therapy. Since adherence has been shown to be a measure for treatment's acceptability and a determinant for treatment's effectiveness, in this study, we explored adherence to a new blended smoking cessation treatment (BSCT). OBJECTIVE: The objective of our study was to (1) develop an adequate method to measure adherence to BSCT; (2) define an adequate degree of adherence to be used as a threshold for being adherent; (3) estimate adherence to BSCT; and (4) explore the possible predictors of adherence to BSCT. METHODS: The data of patients (N=75) were analyzed to trace adherence to BSCT delivered at an outpatient smoking cessation clinic. In total, 18 patient activities (eg, using a Web-based smoking diary tool or responding to counselors' messages) were selected to measure adherence; the degree of adherence per patient was compared with quitting success. The minimum degree of adherence of patients who reported abstinence was examined to define a threshold for the detection of adherent patients. The number of adherent patients was calculated for each of the 18 selected activities; the degree of adherence over the course of the treatment was displayed; and the number of patients who were adherent was analyzed. The relationship between adherence and 33 person-, smoking-, and health-related characteristics was examined. RESULTS: The method for measuring adherence was found to be adequate as adherence to BSCT correlated with self-reported abstinence (P=.03). Patients reporting abstinence adhered to at least 61% of BSCT. Adherence declined over the course of the treatment; the percentage of adherent patients per treatment activity ranged from 82% at the start of the treatment to 11%-19% at the final-third of BSCT; applying a 61% threshold, 18% of the patients were classified as adherent. Marital status and social modeling were the best independent predictors of adherence. Patients having a partner had 11-times higher odds of being adherent (OR [odds ratio]=11.3; CI: 1.33-98.99; P=.03). For social modeling, graded from 0 (=partner and friends are not smoking) to 8 (=both partner and nearly all friends are smoking), each unit increase was associated with 28% lower odds of being adherent (OR=0.72; CI: 0.55-0.94; P=.02). CONCLUSIONS: The current study is the first to explore adherence to a blended face-to-face and Web-based treatment (BSCT) based on a substantial group of patients. It revealed a rather low adherence rate to BSCT. The method for measuring adherence to BSCT could be considered adequate because the expected dose-response relationship between adherence and quitting could be verified. Furthermore, this study revealed that marital status and social modeling were independent predictors of adherence. TRIAL REGISTRATION: Netherlands Trial Registry NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113 (Archived by WebCite at http://www.webcitation.org/71BAPwER8).

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study.

BACKGROUND: The number of mobile apps that support smoking cessation is growing, indicating the potential of the mobile phone as a means to support cessation. Knowledge about the potential end users for cessation apps results in suggestions to target potential user groups in a dissemination strategy, leading to a possible increase in the satisfaction and adherence of cessation apps. OBJECTIVE: This study aimed to characterize potential end users for a specific mobile health (mHealth) smoking cessation app. METHODS: A quantitative study was conducted among 955 Dutch smokers and ex-smokers. The respondents were primarily recruited from addiction care facilities and hospitals through Web-based media via websites and forums. The respondents were surveyed on their demographics, smoking behavior, and personal innovativeness. The intention to use and the attitude toward a cessation app were determined on a 5-point Likert scale. To study the association between the characteristics and intention to use and attitude, univariate and multivariate ordinal logistic regression analyses were performed. RESULTS: The multivariate ordinal logistic regression showed that the number of previous quit attempts (odds ratio [OR] 4.1, 95% CI 2.4-7.0, and OR 3.5, 95% CI 2.0-5.9) and the score on the Fagerstrom Test of Nicotine Dependence (OR 0.8, 95% CI 0.8-0.9, and OR 0.8, 95% CI 0.8-0.9) positively correlates with the intention to use a cessation app and the attitude toward cessation apps, respectively. Personal innovativeness also positively correlates with the intention to use (OR 0.3, 95% CI 0.2-0.4) and the attitude towards (OR 0.2, 95% CI 0.1-0.4) a cessation app. No associations between demographics and the intention to use or the attitude toward using a cessation app were observed. CONCLUSIONS: This study is among the first to show that demographic characteristics such as age and level of education are not associated with the intention to use and the attitude toward using a cessation app when characteristics related specifically to the app, such as nicotine dependency and the number of quit attempts, are present in a multivariate regression model. This study shows that the use of mHealth apps depends on characteristics related to the content of the app rather than general user characteristics.

Augmenting Outpatient Alcohol Treatment as Usual With Online Alcohol Avoidance Training: Protocol for a Double-Blind Randomized Controlled Trial.

BACKGROUND: Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically. OBJECTIVE: The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting. METHODS: The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients' adherence, acceptability, and credibility will be examined. RESULTS: The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020. CONCLUSIONS: The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment. TRIAL REGISTRATION: Netherlands Trial Register NTR5087; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5087 (Archived at WebCite http://www.webcitation.org/6wuS4i1tH).

Treatment dropout in web-based cognitive behavioral therapy for patients with eating disorders.

Treatment dropout is an important concern in eating disorder treatments as it has negative implications for patients' outcome, clinicians' motivation, and research studies. Our main objective was to conduct an exploratory study on treatment dropout in a two-part web-based cognitive behavioral therapy with asynchronous therapeutic support. The analysis included 205 female patients with eating disorders. Reasons for dropout, treatment experiences, and predictors of dropout were analyzed. Overall treatment dropout was 37.6%, with 18.5% early dropout (before or during treatment part 1) and 19.0% late dropout (after part 1 or during part 2). Almost half of the participants identified personal circumstances as reason for dropout. The other participants mostly reported reasons related to the online delivery or treatment protocol. Predictors of early dropout included reporting less vigor and smoking at baseline and a longer average duration per completed treatment module of part 1. Late dropout was predicted by reporting less vigor at baseline and uncertainty about recommendation of the treatment to others after completion of treatment part 1. Generally, the web-based treatment and online therapeutic support were evaluated positively, although dropouts rated the treatment as significantly less helpful and effective than completers did.

Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study).

BACKGROUND: Smoking cessation can significantly reduce the risk of developing smoking-related diseases. Several face-to-face and web-based treatments have shown to be effective. Blending of web-based and face-to-face treatment is expected to improve smoking cessation treatment. The primary objective of this study is to compare the prolonged abstinence rate of the blended smoking cessation treatment with the face-to-face treatment. Secondary objectives are to assess the benefits of blended treatment in terms of cost effectiveness and patient satisfaction, and to identify mechanisms underlying successful smoking cessation. METHODS/DESIGN: This study will be a single-center randomized controlled non-inferiority-trial with parallel group design. Patients (n = 344) will be randomly assigned to either the blended or the face-to-face group. Both treatments will consist of ten sessions with equal content held within 6 months. In the blended treatment five out of ten sessions will be delivered online. The treatments will cover the majority of behavior change techniques that are evidence-based within smoking cessation counseling. All face-to-face sessions in both treatments will take place at the outpatient smoking cessation clinic of a hospital. The primary outcome parameter will be biochemically validated prolonged abstinence at 15 months from the start of the smoking cessation treatment. DISCUSSION: This RCT will be the first study to examine the effectiveness of a blended smoking cessation treatment. It will also be the first study to explore patient satisfaction, adherence, cost-effectiveness, and the clinically relevant influencing factors of a blended smoking cessation treatment. The findings of this RCT are expected to substantially strengthen the base of evidence available to inform the development and delivery of smoking cessation treatment. TRIAL REGISTRATION: Nederlands Trialregister NTR5113 . Registered 24 March 2015.

Web-Based Cognitive Behavioral Therapy for Female Patients With Eating Disorders: Randomized Controlled Trial.

BACKGROUND: Many patients with eating disorders do not receive help for their symptoms, even though these disorders have severe morbidity. The Internet may offer alternative low-threshold treatment interventions. OBJECTIVE: This study evaluated the effects of a Web-based cognitive behavioral therapy (CBT) intervention using intensive asynchronous therapeutic support to improve eating disorder psychopathology, and to reduce body dissatisfaction and related health problems among patients with eating disorders. METHODS: A two-arm open randomized controlled trial comparing a Web-based CBT intervention to a waiting list control condition (WL) was carried out among female patients with bulimia nervosa (BN), binge eating disorder (BED), and eating disorders not otherwise specified (EDNOS). The eating disorder diagnosis was in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and was established based on participants' self-report. Participants were recruited from an open-access website, and the intervention consisted of a structured two-part program within a secure Web-based application. The aim of the first part was to analyze participant's eating attitudes and behaviors, while the second part focused on behavioral change. Participants had asynchronous contact with a personal therapist twice a week, solely via the Internet. Self-report measures of eating disorder psychopathology (primary outcome), body dissatisfaction, physical health, mental health, self-esteem, quality of life, and social functioning were completed at baseline and posttest. RESULTS: A total of 214 participants were randomized to either the Web-based CBT group (n=108) or to the WL group (n=106) stratified by type of eating disorder (BN: n=44; BED: n=85; EDNOS: n=85). Study attrition was low with 94% of the participants completing the posttest assignment. Overall, Web-based CBT showed a significant improvement over time for eating disorder psychopathology (F97=63.07, P<.001, d=.82) and all secondary outcome measures (effect sizes between d=.34 to d=.49), except for Body Mass Index. WL participants also improved on most outcomes; however, effects were smaller in this group with significant between-group effects for eating disorder psychopathology (F201=9.42, P=.002, d=.44), body dissatisfaction (F201=13.16, P<.001, d=.42), physical health (F200=12.55, P<.001, d=.28), mental health (F203=4.88, P=.028, d=.24), self-esteem (F202=5.06, P=.026, d=.20), and social functioning (F205=7.93, P=.005, d=.29). Analyses for the individual subgroups BN, BED, and EDNOS showed that eating disorder psychopathology improved significantly over time among Web-based CBT participants in all three subgroups; however, the between-group effect was significant only for participants with BED (F78=4.25, P=.043, d=.61). CONCLUSIONS: Web-based CBT proved to be effective in improving eating disorder psychopathology and related health among female patients with eating disorders. TRIAL REGISTRATION: Nederlands Trial Register (NTR): NTR2415; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2415 (Archived by WebCite at http://www.webcitation.org/6T2io3DnJ).

A 9-month follow-up of a 3-month web-based alcohol treatment program using intensive asynchronous therapeutic support.

BACKGROUND: Web-based alcohol interventions have demonstrated efficacy in randomized controlled trials. However, most studies have involved self-help interventions without therapeutic support. OBJECTIVES: To examine the results of a 3-month web-based alcohol treatment program using intensive, asynchronous (non-simultaneous) therapeutic support ( www.alcoholdebaas.nl ) at 9-month follow-up assessment. METHODS: This study reports the follow-up results of 144 problem drinking participants who received a web-based alcohol treatment program. We investigated whether the intervention effects at treatment completion (3 months) continued to exist at 6 and 9 months of follow-up. The primary outcome measure was weekly alcohol consumption. Repeated measures analysis with a mixed model approach was used to address loss to follow-up. RESULTS: Weekly alcohol consumption significantly improved between baseline and 9 months (F(1,74) = 85.6, p < 0.001). Post-hoc tests revealed that the reduction occurred during the first 3 months (from 39.9-11.4 standard units a week). Although alcohol consumption had risen to 19.5 units per week at 9 months, it still decreased by more than 20 units compared to baseline drinking. Significant improvements with medium to large effect sizes were found on the secondary outcomes (depression, general health, and quality of life) at 9 months. CONCLUSION: The web-based alcohol treatment with intensive asynchronous therapeutic support has been shown to be effective in reducing alcohol consumption and improving health status at post treatment assessments. The present study showed that most of these improvements were sustained after 9 months. Despite the lack of a control group and the high dropout rate, our findings suggest that web-based treatment can achieve relevant health gains in the long term.

Is the Eating Disorder Questionnaire-Online (EDQ-O) a valid diagnostic instrument for the DSM-IV-TR classification of eating disorders?

BACKGROUND: The Eating Disorder Questionnaire-Online (EDQ-O) is an online self-report questionnaire, which was developed specifically to provide a DSM-IV-TR classification of anorexia nervosa (AN), bulimia nervosa (BN), binge-eating disorder (BED), and eating disorder not otherwise specified (EDNOS), without using a face-to-face clinical interview. OBJECTIVE: The purpose of the present study was to examine the psychometric quality of the EDQ-O. METHODS: The validity of the EDQ-O was determined by examining the agreement with the diagnoses obtained from the Longitudinal, Expert, and All DATA (LEAD) standard. Participants included 134 new patients of a specialist center for eating disorders located in the Netherlands. RESULTS: Assessment of the validity of the EDQ-O yielded acceptable to good AUC (area under the receiver operating characteristic curve) values with a range from 0.72 to 0.83. Most other diagnostic efficiency statistics were also good except for a low sensitivity for AN (0.44), a low positive predictive value for BN (0.50), and a relatively low sensitivity for BED (0.66). CONCLUSION: The results of the present study suggest that the EDQ-O performs acceptably as a diagnostic instrument for all DSM-IV-TR eating disorder classifications. However, suggestions are made to further improve the validity of the EDQ-O.

Capture recapture estimation of the prevalence of mild intellectual disability and substance use disorder.

Persons with mild to borderline intellectual disability (MID) have been identified as a group at risk for substance use disorder (SUD). However, prevalence estimates of co-occurring SUD and MID rely largely on single source studies performed in selected samples. To obtain more reliable population estimates of SUD and MID, this study combines data from an Intellectual Disability Facility (IDF), and an Addiction Treatment Centre (ATC) in a semi-rural area in the Netherlands. Capture-recapture analysis was used to estimate the hidden population (i.e., the population not identified in the original samples). Further analyses were performed for age and gender stratified data. Staff members reported on 88 patients with SUD and MID in the IDF (4.0% of the IDF sample) and 114 in the ATC (5.2% of the ATC sample), with 12 patients in both groups. Only strata for males over 30 years provided reliable population estimates. Based on 97 patients in these strata, the hidden population was estimated at 215. Hence the estimated total population of males over 30 years old with MID and SUD was 312 (95% CI 143-481), approximately 0.16% (0.05-0.25%) of the total population of this age and gender group. This illustrates that while patients with co-occurring SUD and MID often receive professional help from only one service provider, single source data underestimate its prevalence, and thus underestimate treatment and service needs. Therefore, population prevalence estimations of co-occurring SUD and MID should be based on combined multiple source data.