Background Online self-help interventions for problem drinkers show promising results, but the effectiveness of online therapy with active involvement of a therapist via the Internet only has not been examined.Objective The objective of our study was to evaluate an e-therapy program with active therapeutic involvement for problem drinkers, with the hypotheses that e-therapy would (1) reduce weekly alcohol consumption, and (2) improve health status. Reasons for dropout were also systematically investigated.Method In an open randomized controlled trial, Dutch-speaking problem drinkers in the general population were randomly assigned (in blocks of 8, according to a computer-generated random list) to the 3-month e-therapy program (n = 78) or the waiting list control group (n = 78). The e-therapy program consisted of a structured 2-part online treatment program in which the participant and the therapist communicated asynchronously, via the Internet only. Participants in the waiting list control group received “no-reply” email messages once every 2 weeks. The primary outcome measures were (1) the difference in the score on weekly alcohol consumption, and (2) the proportion of participants drinking under the problem drinking limit. Intention-to-treat analyses were performed using multiple imputations to deal with loss to follow-up. A dropout questionnaire was sent to anyone who did not complete the 3-month assessment. Reasons for dropout were independently assessed by the first and third author.Results Of the 156 individuals who were randomly assigned, 102 (65%) completed assessment at 3 months. In the intention-to-treat analyses, the e-therapy group (n = 78) showed a significantly greater decrease in alcohol consumption than those in the control group (n = 78) at 3 months. The e-therapy group decreased their mean weekly alcohol consumption by 28.8 units compared with 3.1 units in the control group, a difference in means of 25.6 units on a weekly basis (95% confidence interval 15.69-35.80, P < .001). The between-group effect size (pooled SD) was large (d = 1.21). The results also showed that 68% (53/78) of the e-therapy group was drinking less than 15 (females) or 22 (males) units a week, compared with 15% (12/78) in the control group (OR 12.0, number needed to treat 1.9, P < .001). Dropout analysis showed that the main reasons for dropouts (n = 54) were personal reasons unrelated to the e-therapy program, discomfort with the treatment protocol, and satisfaction with the positive results achieved.Conclusions E-therapy for problem drinking is an effective intervention that can be delivered to a large population who otherwise do not seek help for their drinking problem. Insight into reasons for dropout can help improve e-therapy programs to decrease the number of dropouts. Additional research is needed to directly compare the effectiveness of the e-therapy program with a face-to-face treatment program.Trial registration ISRCTN39104853; http://controlled-trials.com/ISRCTN39104853/ISRCTN39104853 (Archived by WebCite at http...
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 crosscorrelation; (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.
BackgroundWeb-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.ObjectiveThe 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.MethodsAttrition 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.ResultsThe open-access and RCT group differed significantly in the percentage of treatment completers (273/780, 35.0% vs 65/144, 45%, χ2 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.ConclusionsThe 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.TrialInternational Standard Randomized Controlled Trial Number (ISRCTN): 39104853; http://www.controlled-trials.com/ISRCTN39104853 (Archived by WebCite at http://www.webcitation.org/63IKDul1T)
BackgroundMany 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.ObjectiveThis 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.MethodsA 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.ResultsA 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 (F 97=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 (F 201=9.42, P=.002, d=.44), body dissatisfaction (F 201=13.16, P<.001, d=.42), physical health (F 200=12.55, P<.001, d=.28), mental health (F 203=4.88, P=.028, d=.24), self-esteem (F 202=5.06, P=.026, d=.20), and social functioning (F 205=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 (F 78=4.25, P=.043, d=.61).ConclusionsWeb-based CBT proved to be effective in improving eating disorder psychopathology and related health among female patients with eating disorders.Trial RegistrationNederlands Trial Register (NTR): NTR2415; http://www.trialre...
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