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.

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.

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 ).

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.

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.

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.

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.

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.

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.

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.

Effectiveness of a web-based treatment program using intensive therapeutic support for female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified: study protocol of a randomized controlled trial.

BACKGROUND: Disordered eating behavior and body dissatisfaction affect a large proportion of the Dutch population and account for severe psychological, physical and social morbidity. Yet, the threshold for seeking professional care is still high. In the Netherlands, only 7.5% of patients with bulimia nervosa and 33% of patients with anorexia nervosa are treated within the mental health care system. Easily accessible and low-threshold interventions, therefore, are needed urgently. The internet has great potential to offer such interventions. The aim of this study is to determine whether a web-based treatment program for patients with eating disorders can improve eating disorder psychopathology among female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified. METHODS/DESIGN: This randomized controlled trial will compare the outcomes of an experimental treatment group to a waiting list control group. In the web-based treatment program, participants will communicate personally and asynchronously with their therapists exclusively via the internet. The first part of the program will focus on analyzing eating attitudes and behaviors. In the second part of the program participants will learn how to change their attitudes and behaviors. Participants assigned to the waiting list control group will receive no-reply email messages once every two weeks during the waiting period of 15 weeks, after which they can start the program. The primary outcome measure is an improvement in eating disorder psychopathology as determined by the Eating Disorder Examination Questionnaire. Secondary outcomes include improvements in body image, physical and mental health, body weight, self-esteem, quality of life, and social contacts. In addition, the participants' motivation for treatment and their acceptability of the program and the therapeutic alliance will be measured. The study will follow the recommendations in the CONSORT statement relating to designing and reporting on RCTs. DISCUSSION: This study protocol presents the design of a RCT for evaluating the effectiveness of a web-based treatment program using intensive therapeutic support for female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified. TRIAL REGISTRATION: The protocol for this study is registered with the Netherlands Trial Registry NTR2415.

Web-based treatment program using intensive therapeutic contact for patients with eating disorders: before-after study.

BACKGROUND: Although eating disorders are common in the Netherlands, only a few patients are treated by mental health care professionals. To reach and treat more patients with eating disorders, Tactus Addiction Treatment developed a web-based treatment program with asynchronous and intensive personalized communication between the patient and the therapist. OBJECTIVE: This pilot study evaluated the web-based treatment program using intensive therapeutic contact in a population of 165 patients with an eating disorder. METHODS: In a pre-post design with 6-week and 6-month follow-ups, eating disorder psychopathology, body dissatisfaction, Body Mass Index, physical and mental health, and quality of life were measured. The participant's satisfaction with the web-based treatment program was also studied. Attrition data were collected, and participants were classified as noncompleters if they did not complete all 10 assignments of the web-based treatment program. Differences in baseline characteristics between completers and noncompleters were studied, as well as reasons for noncompletion. Furthermore, differences in treatment effectiveness, treatment adherence, and baseline characteristics between participants of the three major eating disorder diagnostic groups EDNOS (n=115), BN purging (n=24), and BN nonpurging (n=24) were measured. RESULTS: Of the 165 participants who started the web-based treatment program, 89 participants (54%) completed all of the program assignments (completers) and 76 participants (46%) ended the program prematurely (noncompleters). Severe body dissatisfaction and physical and mental health problems seemed to have a negative impact on the completion of the web-based treatment program. Among the participants who completed the treatment program, significant improvements were found in eating disorder psychopathology (F=54.6, df = 68, P<.001, d=1.14). Body dissatisfaction, quality of life, and physical and mental health also significantly improved, and almost all of these positive effects were sustained up to 6 months after the participants had completed the web-based treatment program. Body Mass Index improved only within the group of participants suffering from obesity. The improvement in eating disorder psychopathology occurred in all three eating disorder diagnostic groups, and the percentage of completers did not differ significantly between these groups. Participants' satisfaction with the treatment program, as well as with their therapist, was high, and participants indicated that they would recommend the program to other patients with eating disorders. CONCLUSIONS: The results of this study suggest that the web-based treatment program has the potential to improve eating disorder psychopathology in patients with different types of eating disorders.

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.

Therapeutic Alliance in Web-Based Treatment for Eating Disorders: Secondary Analysis of a Randomized Controlled Trial.

BACKGROUND: In face-to-face therapy for eating disorders, therapeutic alliance (TA) is an important predictor of symptom reduction and treatment completion. To date, however, little is known about TA during web-based cognitive behavioral therapy (web-CBT) and its association with symptom reduction, treatment completion, and the perspectives of patients versus therapists. OBJECTIVE: This study aimed to investigate TA ratings measured at interim and after treatment, separately for patients and therapists; the degree of agreement between therapists and patients (treatment completers and noncompleters) for TA ratings; and associations between patient and therapist TA ratings and both eating disorder pathology and treatment completion. METHODS: A secondary analysis was performed on randomized controlled trial data of a web-CBT intervention for eating disorders. Participants were 170 females with bulimia nervosa (n=33), binge eating disorder (n=68), or eating disorder not otherwise specified (n=69); the mean age was 39.6 (SD 11.5) years. TA was operationalized using the Helping Alliance Questionnaire (HAQ). Paired t tests were conducted to assess the change in TA from interim to after treatment. Intraclass correlations were calculated to determine cross-informant agreement with regard to HAQ scores between patients and therapists. A total of 2 stepwise regressive procedures (at interim and after treatment) were used to examine which HAQ scores predicted eating disorder pathology and therapy completion. RESULTS: For treatment completers (128/170, 75.3%), the HAQ-total scores and HAQ-Helpfulness scores for both patients and therapists improved significantly from interim to post treatment. For noncompleters (42/170, 24.7%), all HAQ scores decreased significantly. For all HAQ scales, the agreement between patients and therapists was poor. However, the agreement was slightly better after treatment than at interim. Higher patient scores on the helpfulness subscale of the HAQ at interim and after treatment were associated with less eating disorder psychopathology. A positive association was found between the HAQ-total patient scores at interim and treatment completion. Finally, posttreatment HAQ-total patient scores and posttreatment HAQ-Helpfulness scores of therapists were positively associated with treatment completion. CONCLUSIONS: Our study showed that TA in web-CBT is predictive of eating disorder pathology and treatment completion. Of particular importance is patients' confidence in their abilities as measured with the HAQ-Helpfulness subscale when predicting posttreatment eating disorder pathology and treatment completion.

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.

Attrition in web-based treatment for problem drinkers.

BACKGROUND: Web-based interventions for problem drinking are effective but characterized by high rates of attrition. There is a need to better understand attrition rates in order to improve the completion rates and the success of Web-based treatment programs. OBJECTIVE: The objectives of our study were to (1) examine attrition prevalence and pretreatment predictors of attrition in a sample of open-access users of a Web-based program for problem drinkers, and (2) to further explore attrition data from our randomized controlled trial (RCT) of the Web-based program. METHODS: Attrition data from two groups of Dutch-speaking problem drinkers were collected: (1) open-access participants enrolled in the program in 2009 (n = 885), and (2) RCT participants (n = 156). Participants were classified as noncompleters if they did not complete all 12 treatment sessions (9 assignments and 3 assessments). In both samples we assessed prevalence of attrition and pretreatment predictors of treatment completion. Logistic regression analysis was used to explore predictors of treatment completion. In the RCT sample, we additionally measured reasons for noncompletion and participants' suggestions to enhance treatment adherence. The qualitative data were analyzed using thematic analysis. RESULTS: The open-access and RCT group differed significantly in the percentage of treatment completers (273/780, 35.0% vs 65/144, 45%, χ(2) (1) = 5.4, P = .02). Logistic regression analysis revealed a significant contribution of treatment readiness, gender, education level, age, baseline alcohol consumption, and readiness to change to predict treatment completion. The key reasons for noncompletion were personal reasons, dissatisfaction with the intervention, and satisfaction with their own improvement. The main suggestions for boosting strategies involved email notification and more flexibility in the intervention. CONCLUSIONS: The challenge of Web-based alcohol treatment programs no longer seems to be their effectiveness but keeping participants involved until the end of the treatment program. Further research should investigate whether the suggested strategies to improve adherence decrease attrition rates in Web-based interventions. If we can succeed in improving attrition rates, the success of Web-based alcohol interventions will also improve and, as a consequence, their public health impact will increase. TRIAL: International Standard Randomized Controlled Trial Number (ISRCTN): 39104853; http://www.controlled-trials.com/ISRCTN39104853 (Archived by WebCite at http://www.webcitation.org/63IKDul1T).

Characteristics of problem drinkers in e-therapy versus face-to-face treatment.

BACKGROUND: The availability of online treatment programs offers the potential to reach more problem drinkers. This study compared the client populations of an e-therapy program (asynchronous client-therapist communication via the Internet) and a face-to-face treatment program. OBJECTIVE: To determine whether e-therapy and face-to-face groups differed from each other and changed over time. METHODS: We compared the baseline characteristics of four naturalistic groups (N = 4593): two e-therapy groups (2005-2006 and 2008-2009) and two consecutive series of ambulant face-to-face clients admitted for treatment as usual. The characteristics we were interested in were gender, age, education level, working situation, and earlier treatment for drinking problems. RESULTS: The results showed that the baseline characteristics of e-therapy and face-to-face clients differed by gender, education level, work situation, prior alcohol treatment, and age. We also found that both e-therapy groups differed over time by gender, work situation, and prior alcohol treatment. CONCLUSIONS: The e-therapy program successfully attracted clients who were different from those who were represented in regular face-to-face alcohol treatment services. This indicates that e-therapy decreases the barriers to treatment facilities and enhances the accessibility. However, the e-therapy population changed over time. Although the e-therapy program still reached an important new group of clients in 2008-2009, this group showed more overlap with the traditional face-to-face group of clients probably as a result of improved acceptance of e-therapy in the general population. SCIENTIFIC SIGNIFICANCE: Although e-therapy seems to be better accepted in the general population, anonymous treatment seems necessary to reach a broader range of problem drinkers.

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).