Brian G. Danaher

Background: Individuals living with a partner with an alcohol use disorder (AUD) can experience significant psychological distress and use health care more than those without a partner with an AUD. However, the prevailing treatment system’s focus on the partner and personal barriers limit these individuals from getting help for themselves. Preliminary work on a self-directed, web-based coping skills training program, Stop Spinning My Wheels (SSMW), shows promise in broadening available treatments for this population. In this study, we conducted a robust evaluation of SSMW primary outcomes. Objective: The study aims to test whether women with a partner with an AUD assigned to SSMW experienced a greater reduction in negative affect (depression and anger) (1) than a usual web care (UWC) control and (2) with brief phone coach support (SSMW+coach) rather than without (SSMW only) and (3) whether baseline negative affect moderated treatment effects. Methods: Women (mean age 45.7, SD 10.8 years; Black: 17/456, 3.7%; White: 408/456, 89.5%) were randomized to SSMW only, SSMW+coach, or UWC. Depression (Beck Depression Inventory–II) and anger (State-Trait Anger Expression Inventory 2–State Anger) were assessed at baseline, 12-week posttest, and 6- and 12-month follow-ups. Results: Participants in all conditions decreased in depression from baseline to posttest and from baseline to follow-up; SSMW-only and SSMW+coach participants decreased in anger, but UWC participants did not. Compared to UWC participants, SSMW-only participants experienced greater anger reduction (P=.03), and SSMW+coach participants experienced a greater reduction in depression (P<.001) from baseline to posttest. However, from baseline to follow-up, only a greater, but not statistically significant (P=.052), reduction in anger occurred in SSMW+coach compared to UWC. Although the SSMW conditions did not differ from each other in negative affect outcomes (P=.06-.57), SSMW+coach had higher program engagement and satisfaction (all P<.004). Baseline negative affect did not moderate effects, although remission from baseline clinically relevant depressive symptoms (Beck Depression Inventory≥14) was higher in SSMW only (33/67, 49%; odds ratio 2.13, 95% CI 1.05-4.30; P=.03) and SSMW+coach (46/74, 62%; odds ratio 3.60, 95% CI 1.79-7.23; P<.001) than in UWC (21/67, 31%); remission rates did not differ between the SSMW conditions (P=.12). Conclusions: The results partially supported the hypotheses. The SSMW conditions had earlier effects than UWC, but positive change in UWC mitigated the hypothesized long-term SSMW-UWC differences. The results highlight the importance of incorporating active controls in web-based clinical trials. Although SSMW+coach showed benefits over SSMW only on engagement and satisfaction measures and in the number needed to treat (5.6 for SSMW only; 3.2 for SSMW+coach), the SSMW conditions were comparable and superior to UWC on depressive symptom remission levels. Overall, SSMW with or without a coach can reduce clinically meaningful distress and add to available treatment options for this large, underserved group. Trial Registration: ClinicalTrials.gov NCT02984241; https://www.clinicaltrials.gov/study/NCT02984241

BACKGROUND Individuals living with a partner with an alcohol use disorder (AUD) can experience significant psychological distress and use health care more than those without a partner with an AUD. However, the prevailing treatment system’s focus on the partner and personal barriers limit these individuals from getting help for themselves. Preliminary work on a self-directed, web-based coping skills training program, Stop Spinning My Wheels (SSMW), shows promise in broadening available treatments for this population. In this study, we conducted a robust evaluation of SSMW primary outcomes. OBJECTIVE The study aims to test whether women with a partner with an AUD assigned to SSMW experienced a greater reduction in negative affect (depression and anger) (1) than a usual web care (UWC) control and (2) with brief phone coach support (SSMW+coach) rather than without (SSMW only) and (3) whether baseline negative affect moderated treatment effects. METHODS Women (mean age 45.7, SD 10.8 years; Black: 17/456, 3.7%; White: 408/456, 89.5%) were randomized to SSMW only, SSMW+coach, or UWC. Depression (Beck Depression Inventory–II) and anger (State-Trait Anger Expression Inventory 2–State Anger) were assessed at baseline, 12-week posttest, and 6- and 12-month follow-ups. RESULTS Participants in all conditions decreased in depression from baseline to posttest and from baseline to follow-up; SSMW-only and SSMW+coach participants decreased in anger, but UWC participants did not. Compared to UWC participants, SSMW-only participants experienced greater anger reduction (P=.03), and SSMW+coach participants experienced a greater reduction in depression (P<.001) from baseline to posttest. However, from baseline to follow-up, only a greater, but not statistically significant (P=.052), reduction in anger occurred in SSMW+coach compared to UWC. Although the SSMW conditions did not differ from each other in negative affect outcomes (P=.06-.57), SSMW+coach had higher program engagement and satisfaction (all P<.004). Baseline negative affect did not moderate effects, although remission from baseline clinically relevant depressive symptoms (Beck Depression Inventory≥14) was higher in SSMW only (33/67, 49%; odds ratio 2.13, 95% CI 1.05-4.30; P=.03) and SSMW+coach (46/74, 62%; odds ratio 3.60, 95% CI 1.79-7.23; P<.001) than in UWC (21/67, 31%); remission rates did not differ between the SSMW conditions (P=.12). CONCLUSIONS The results partially supported the hypotheses. The SSMW conditions had earlier effects than UWC, but positive change in UWC mitigated the hypothesized long-term SSMW-UWC differences. The results highlight the importance of incorporating active controls in web-based clinical trials. Although SSMW+coach showed benefits over SSMW only on engagement and satisfaction measures and in the number needed to treat (5.6 for SSMW only; 3.2 for SSMW+coach), the SSMW conditions were comparable and superior to UWC on depressive symptom remission levels. Overall, SSMW with or without a coach can reduce clinically meaningful distress and add to available treatment options for this large, underserved group. CLINICALTRIAL ClinicalTrials.gov NCT02984241; https://www.clinicaltrials.gov/study/NCT02984241

Background: Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND.Objective: This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT).Methods: In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up.Results: Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups.Conclusions: In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment.Trial Registration: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true

BACKGROUND Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND. OBJECTIVE This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT). METHODS In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up. RESULTS Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups. CONCLUSIONS In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. CLINICALTRIAL Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet

This study evaluated the efficacy of a family-centered preventive intervention, the Family Check-Up (FCU), delivered as an online, eHealth model to middle school families. To increase accessibility of family-centered prevention in schools, we adapted the evidence-based FCU to an online format, with the goal of providing a model of service delivery that is feasible, given limited staffing and resources in many schools. Building on prior research, we randomly assigned participants to waitlist control (n= 105), FCU Online as a web-based intervention (n= 109), and FCU Online with coaching support (n= 108). We tested the effects of the intervention on multiple outcomes, including parental self-efficacy, child self-regulation, and child behavior, in this registered clinical trial (NCT03060291). Families engaged in the intervention at a high rate (72% completed the FCU assessment) and completed 3-month posttest assessments with good retention (94% retained). Random assignment to the FCU Online with coaching support was associated with reduced emotional problems for children (p= .003,d= −0.32) and improved parental confidence and self-efficacy (p= .018,d= 0.25) when compared with waitlist controls. Risk moderated effects: at-risk youth showed stronger effects than did those with minimal risk. The results have implications for online delivery of family-centered interventions in schools.

Background: Research has established that skillful family management during adolescence protects youth from a variety of mental health and behavioral problems. Interventions associated with this research have focused on parenting skills as the mediator that links early risk factors with a profile of later behavioral risk, including problem behavior, substance use, and school failure. Fortunately, positive changes in family management skills have been linked to meaningful improvements in adolescent behavior, and these improvements have been significant across a variety of cultural groups. Objective: We describe the background, research design, and intervention components of an electronic health version of the Family Check-Up program that is targeting middle school children and is being evaluated in a randomized controlled trial for its usability, feasibility, and efficacy. Methods: We used an iterative formative research process to develop an electronic health version of the Family Check-Up program. In our ongoing randomized controlled trial, eligible families are randomly assigned to 1 of 3 conditions: Family Check-Up Online-only (n approximate to 100), Family Check-Up Online + Coach (n approximate to 100), and a waitlist control condition (middle school as usual; n approximate to 100). We are conducting assessments at baseline, 3 months following randomization (posttest), and at follow-ups scheduled for 6 months and 12 months. Results: This randomized controlled trial project was funded in 2015. Participant recruitment was completed in spring 2018 and enrollment is ongoing. Follow-up assessments will be completed in 2019. Conclusions: The innovative Family Check-Up Online program has the potential to help address many of the barriers that more traditional school-based behavioral mental health implementation strategies have yet to solve, including staffing and resources to implement family-centered support within schools.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Research has established that skillful family management during adolescence protects youth from a variety of mental health and behavioral problems. Interventions associated with this research have focused on parenting skills as the mediator that links early risk factors with a profile of later behavioral risk, including problem behavior, substance use, and school failure. Fortunately, positive changes in family management skills have been linked to meaningful improvements in adolescent behavior, and these improvements have been significant across a variety of cultural groups. Objective: We describe the background, research design, and intervention components of an electronic health version of the Family Check-Up program that is targeting middle school children and is being evaluated in a randomized controlled trial for its usability, feasibility, and efficacy. Methods: We used an iterative formative research process to develop an electronic health version of the Family Check-Up program. In our ongoing randomized controlled trial, eligible families are randomly assigned to 1 of 3 conditions: Family Check-Up Online-only (n≈100), Family Check-Up Online + Coach (n≈100), and a waitlist control condition (middle school as usual; n≈100). We are conducting assessments at baseline, 3 months following randomization (posttest), and at follow-ups scheduled for 6 months and 12 months. Results: This randomized controlled trial project was funded in 2015. Participant recruitment was completed in spring 2018 and enrollment is ongoing. Follow-up assessments will be completed in 2019. Conclusions: The innovative Family Check-Up Online program has the potential to help address many of the barriers that more traditional school-based behavioral mental health implementation strategies have yet to solve, including staffing and resources to implement family-centered support within schools. Trial Registration: ClinicalTrials.gov NCT03060291; https://clinicaltrials.gov/ct2/show/NCT03060291 (Archived by WebCite at http://www.webcitation.org/70f8keeN4) Trial Registration: RR1-10.2196/11106

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Despite showing initial interest in using an eHealth intervention, a noteworthy number of participants abandon their treatment either by visiting their treatment program a single time (One Timers) or never accessing it at all (No Timers). More knowledge about these two categories of treatment abandoners is needed to inform research design, clinical practice and policy. Objective: To examine the prevalence, characteristics, and outcomes of eHealth abandoners and possible impact on analyses of program efficacy, reach, and policy. Methods: We performed secondary data analysis of results derived from four RCTs of eHealth smokeless tobacco cessation interventions (N = 2739). Assessments occurred at baseline and at 3- and 6-months follow-up. Program usage data collected unobtrusively were examined separately for each RCT and in aggregate. Results: We classified 1295 tobacco users wanting to quit to have been abandoners – 162 (6%) of them were No timers (0 visits) and 1133 (41%) were One Timers (1 visit). This absolute level of abandonment is comparable with levels cited in other published reports. Analyses showed that abandoners shared a cluster of characteristics that distinguishes them from other participants, including program completers. The two types of abandoners did not differ from each other in terms of assessment completion at 3 months (OR = 0.920, 95% CI [0.662, 1.279], p = .620) or at 6 months (OR = 0.923, 95% CI [0.664, 1.284], p= .635) but both were less likely to complete assessments than non-abandoners: at 3 months (OR =0.221, 95% CI [0.184, 0.266], p < .001) and at 6 months (OR = 0.269, 95% CI [0.225, 0.321], p < .001). For Complete Case participants (those who completed follow-up assessments), abandoners reported less abstinence than non-abandoners at all follow-up assessments: at 3 months (OR= 1.991, 95% CI [1.593, 2.488], p < .001), at 6 months (OR= 1.301, 95% CI [1.049, 1.615], p= .017), and at both assessments (OR= 1.645, 95% CI [1.273, 2.125], p < .001). A similar pattern but lower abstinence obtained using Intent to Treat (ITT) analyses at 3 months (OR= 3.053, 95% CI [2.527, 3.688], p < .001), at 6 months (OR= 2.059, 95% CI [1.726, 2.457], p < .001), and at both 3 and 6 months (OR= 2.787, 95% CI [2.244, 3.461], p < .001). Conclusions: Analyses of patterns of program engagement were used to identify a subgroup of participants who prematurely stopped using – or did not use – their assigned Web-based tobacco cessation intervention. Implications discussed focused on the balance between highly controlled efficacy research versus “realistically sustainable” pragmatic implementations of high-reach eHealth interventions. Better understanding of treatment abandoners may point to possible remedies but cautions are noted about using remedies that negatively impact external validity.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet