BackgroundThere are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed.ObjectiveIn a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching.MethodsThis was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women’s diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9).ResultsAt the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average.ConclusionsOur results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT.Trial RegistrationAustralian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).
Background Web-based behavioral intervention research is rapidly growing. Purpose We review methodological issues shared across Web-based intervention research to help inform future research in this area. Methods We examine measures and their interpretation using exemplar studies and our research. Results We report on research designs used to evaluate Web-based interventions and recommend newer, blended designs. We review and critique methodological issues associated with recruitment, engagement, and social validity. Conclusions We suggest that there is value to viewing this burgeoning realm of research from the broader context of behavior change research. We conclude that many studies use blended research designs, that innovative mantling designs such as the Multiphase Optimization Strategy and Sequential Multiple Assignment Randomized Trial methods hold considerable promise and should be used more widely, and that Web-based controls should be used instead of usual care or no-treatment controls in public health research. We recommend topics for future research that address participant recruitment, engagement, and social validity.
BackgroundPostpartum depression (PPD)—the most common complication of childbirth—is a significant and prevalent public health problem that severely disrupts family interactions and can result in serious lasting consequences to the health of women and the healthy development of infants. These consequences increase in severity when left untreated; most women with PPD do not obtain help due to a range of logistical and attitudinal barriers.ObjectiveThis pilot study was designed to test the feasibility, acceptability, and potential efficacy of an innovative and interactive guided Web-based intervention for postpartum depression, MomMoodBooster (MMB).MethodsA sample of 53 women who satisfied eligibility criteria (<9 months postpartum, ≥18 years of age, home Internet access and use of personal email, Edinburgh Postnatal Depression Survey score of 12-20 or Patient Health Questionnaire score from 10-19) were invited to use the MMB program. Assessments occurred at screening/pretest, posttest (3 months following enrollment), and at 6 months follow-up.ResultsAll six sessions of the program were completed by 87% (46/53) of participants. Participants were engaged with the program: visit days (mean 15.2, SD 8.7), number of visits (mean 20.1, SD 12.2), total duration of visits in hours (mean 5.1, SD 1.3), and number of sessions viewed out of six (mean 5.6, SD 1.3) all support high usage. Posttest data were collected from 89% of participants (47/53) and 6-month follow-up data were collected from 87% of participants (46/53). At pretest, 55% (29/53) of participants met PHQ-9 criteria for minor or major depression. At posttest, 90% (26/29) no longer met criteria.ConclusionsThese findings support the expanded use and additional testing of the MMB program, including its implementation in a range of clinical and public health settings.Trial RegistrationClinicaltrials.gov NCT00942721; http://clinicaltrials.gov/ct2/show/NCT00942721 (Archived by WebCite at http://www.webcitation.org/6KjYDvYkQ).
BackgroundPublished research on the use of Web-based behavior change programs is growing rapidly. One of the observations characterized as problematic in these studies is that participants often make relatively few website visits and spend only a brief time accessing the program. Properly structured websites permit the unobtrusive measurement of the ways in which participants access (are exposed to) program content. Research on participant exposure to Web-based programs is not merely of interest to technologists, but represents an important opportunity to better understand the broader theme of program engagement and to guide the development of more effective interventions.ObjectivesThe current paper seeks to provide working definitions and describe initial patterns of various measures of participant exposure to ChewFree.com, a large randomized controlled trial of a Web-based program for smokeless tobacco cessation.MethodsWe examined measures of participant exposure to either an Enhanced condition Web-based program (interactive, tailored, and rich-media program) or a Basic condition control website (static, text-based material). Specific measures focused on email prompting, participant visits (number, duration, and pattern of use over time), and Web page viewing (number of views, types of pages viewed, and Web forum postings).ResultsParticipants in the ChewFree.com Enhanced condition made more visits and spent more time accessing their assigned website than did participants assigned to the Basic condition website. In addition, exposure data demonstrated that Basic condition users thoroughly accessed program content, indicating that the condition provided a meaningful, face-valid control to the Enhanced condition.ConclusionsWe recommend that researchers conducting evaluations of Web-based interventions consider the collection and analysis of exposure measures in the broader context of program engagement in order to assess whether participants obtain sufficient exposure to relevant program content.
The sizeable percentage of adults who use smokeless tobacco (ST) represents an important public health target since the majority of ST users have a strong desire to quit, but many lack resources. We tested the impact of an interactive, tailored Web-based intervention (Enhanced Condition) versus a more linear, text-based website (Basic Condition) in a randomized trial with 2523 adult ST users. As is common in Internet-based research, there was considerable attrition: follow-up rates at 3 months, 6 months, and for both 3 and 6 months were 48%, 45% and 34%, respectively. Results using repeated point prevalence of all tobacco use at 3 and 6 months showed that participants in the Enhanced Condition quit at significantly higher rates than those in the Basic Condition. Using a Complete Case analysis, abstinence was 40.6% in the Enhanced Condition vs. 21.2% in the Basic Condition (p< .001). Using intent-to-treat analysis, quit rates were 12.6% vs. 7.9%, respectively (p< .001). Similar results were obtained for only ST use. Unobtrusive measures of program exposure indicated that program use was significantly related to outcome as well as to attrition. We conclude that a tailored, interactive Web-assisted cessation program can be an efficacious method for assisting adult ST users to quit.
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