Moderators Of Efficacy Research Articles

Rationale and protocol of the StayFitLonger study: a multicentre trial to measure efficacy and adherence of a home-based computerised multidomain intervention in healthy older adults

BackgroundIn older adults, multidomain training that includes physical and cognitive activities has been associated with improvement of physical and cognitive health. The goal of the multisite StayFitLonger study is to assess a home-based computerised training programme, which combines physical exercises, stimulating cognitive activities and virtual coaching.MethodsOne hundred twenty-eight cognitively healthy older adults will be recruited from the community in Switzerland, Canada and Belgium. The study will comprise (1) a 26-week double-blind randomized controlled efficacy trial and (2) a 22-week pragmatic adherence sub-study. In the efficacy trial, participants will be randomly assigned to an experimental or an active control intervention. In the experimental intervention, participants will use the StayFitLonger programme, which is computerised on a tablet and provides content that combines physical activities with a focus on strength and balance, as well as divided attention, problem solving and memory training. Outcomes will be measured before and after 26 weeks of training. The primary efficacy outcome will be performance on the “Timed-Up & Go” test. Secondary outcomes will include measures of frailty, cognition, mood, fear of falling, quality of life, and activities of daily living. Age, sex, education, baseline cognition, expectation, and adherence will be used as moderators of efficacy. Following the 26-week efficacy trial, all participants will use the experimental programme meaning that participants in the control group will ‘cross over’ to receive the StayFitLonger programme for 22 weeks. Adherence will be measured in both groups based on dose, volume and frequency of use. In addition, participants’ perception of the programme and its functionalities will be characterised through usability, acceptability and user experience.DiscussionThis study will determine the efficacy, adherence and participants’ perception of a home-based multidomain intervention programme and its functionalities. This will allow for further development and possible commercialization of a scientifically validated training programme.Trial registrationClinicalTrials.gov, NCT04237519 Registered on January 22, 2020 - Retrospectively registered.

Patient-Centered Placement Matching of Alcohol-Dependent Patients Based on a Standardized Intake Assessment: Primary Outcomes of an Exploratory Randomized Controlled Trial

Background: Placement matching guidelines are promising means to optimize patient-centered care and to match patients’ treatment needs. Despite considerable research regarding placement matching approaches to optimize alcohol abuse treatment, findings are inconclusive. Objectives: To investigate whether the use of patient-centered placement matching (PCPM) guidelines is more effective in reducing heavy drinking and costs 6 months after discharge from an inpatient alcohol withdrawal treatment compared to usual referral to aftercare. Secondary aims were to investigate whether age, gender, trial site or level of care (LOC) are moderators of efficacy and whether patients who were actually referred to the recommended LOC had better treatment outcomes compared to patients who were treated under- or overmatched. Methods: Design. Exploratory randomized controlled trial with measurements during withdrawal treatment and 6 months after initial assessment. Setting. Four German psychiatric clinics offering a 7–21 day inpatient qualified withdrawal program for patients suffering from alcohol dependence. Participants. From 1,927 patients who had a primary diagnosis of alcohol dependence and did not have organized aftercare when entering withdrawal treatment, 299 were invited to participate. Of those, 250 were randomized to the intervention group (IG, n = 123) or the control group (CG, n = 127). Intervention. The PCPM were applied to patients of the IG by feeding back a recommendation to a LOC for aftercare that was calculated from the Measurements in the Addictions for Triage and Evaluation (MATE) and discussed with the staff of the treatment unit. Patients of the CG received a general feedback regarding their MATE interview on request. Measurements. The MATE, the Client Socio-Demographic and Service Receipt Inventory-­European Version and the MATE-Outcomes were administered. Data were analyzed using generalized linear models. Results: In the intention-to-treat analysis, there were no significant differences between IG and CG regarding days of heavy drinking (incident risk ratio [IRR] 1.09; p = 0.640), direct (IRR 1.06; p = 0.779), indirect (IRR 0.77; p = 0.392) and total costs (IRR 0.89; p = 0.496). Furthermore, none of the investigated moderator variables affected statistically significant drinking or cost-related primary outcomes. Regardless of group allocation, patients who received matched aftercare reported significantly fewer days of heavy drinking than undermatched patients (IRR 2.09; p = 0.004). For patients who were overmatched, direct costs were significantly higher (IRR 1.79; p = 0.024), but with no additional effects on alcohol consumption compared to matched patients. Conclusions: While the use of PCPM failed to affect the actual referral to aftercare, our findings suggest that treating patients on the recommended LOC may have the potential to reduce days of heavy drinking compared to undertreatment and costs compared to overtreatment.

Interpersonal Psychotherapy: A Scoping Review and Historical Perspective (1974-2017).

Interpersonal Psychotherapy (IPT) is an affect- and relationally focused, time-limited treatment supported by research spanning >4 decades. IPT focuses on stressful interpersonal experiences of loss, life changes, disputes, and social isolation. It emphasizes the role of relationships in recovery. This scoping review describes, within a historical perspective, IPT's evolution as an evidence-supported treatment of psychiatric disorders. English-language publications (n = 1119) identified via EMBASE, MEDLINE, PsycINFO, and Web of Science databases (1974-2017), augmented with manual reference searches, were coded for clinical focus, population demographics, format, setting, publication type, and research type. Quantitative and qualitative analyses identified IPT publications' characteristics and trends over four epochs of psychotherapy research. IPT literature primarily focused on depression (n = 772 articles; 69%), eating disorders (n = 135; 12%), anxiety disorders (n = 68; 6%), and bipolar disorder (n = 44; 4%), with rising publication rates and numbers of well-conducted randomized, controlled trials over time, justifying inclusion in consensus treatment guidelines. Research trends shifted from efficacy trials to effectiveness studies and population-based dissemination initiatives. Process research examined correlates of improvement and efficacy moderators. Innovations included global initiatives, prevention trials, and digital, web-based training and treatment. Sparked by clinical innovations and scientific advances, IPT has evolved as an effective treatment of psychiatric disorders across the lifespan for diverse patients, including underserved clinical populations. Future research to elucidate mechanisms of change, improve access, and adapt to changing frameworks of psychopathology and treatment planning is needed. IPT addresses the universal centrality of relationships to mental health, which is as relevant today as it was over 40 years ago.

Efficacy and feasibility of a humor training for people suffering from depression, anxiety, and adjustment disorder: a randomized controlled trial

BackgroundHumor trainings have positive effects on mental health and well-being. However, studies investigating the effects of humor trainings in clinical samples are still rare. This study investigated the efficacy and feasibility of a humor training for people suffering from depression, anxiety and adjustment disorders.MethodsBased on a diagnostic interview (SCID I and II), 37 people were randomized into a training (n = 19) or wait list control group (n = 18) and completed questionnaires at pre, post, and 1 month follow-up. After the training group had completed its training and evaluation measures, the wait list control group received the training and the outcomes of the group were additionally evaluated (post2 and follow-up2).ResultsAfter training, improvements in humor-related outcomes were observed for the training group, but these were relativized when compared to the wait list control group. Secondary outcomes remained unaffected by the training. In addition, the training group reported interpersonal difficulties. Within-group analyses of the wait list control group after completion of their training showed effects on almost all primary and secondary outcomes and feedback indicated a better atmosphere.ConclusionsIn summary, the different outcomes of the two groups are surprising and can show potential moderators of efficacy, such as interpersonal and group-specific climate variables. Since moderators of humor trainings in clinical samples have not been investigated at all, future studies should consider integrating them into their design.Trial registrationThe study was retrospectively registered in the German Clinical Trials Register (DRKS00012443) on May 16, 2017.

Mood, Meth, Condom Use, and Gender: Latent Growth Curve Modeling Results from a Randomized Trial

Methamphetamine use poses increased risk for HIV and other sexually transmitted infections. There is robust evidence that methamphetamine use increases sexual risk behavior, like condomless sex, primarily among men who have sex with men but also among heterosexual women and men. Gender differences have been found among women and men who use meth, and there is a high degree of interconnectedness between meth use, depression, and condomless sex. The aims of the current study are to evaluate the efficacy of a theory-based, tri-focal intervention designed to reduce depression, meth use, and condomless sex among women and men, and to examine gender as a moderator of efficacy. A total of 432 HIV-negative women and men who use meth participated in a two-arm randomized controlled trial and completed baseline and follow-up assessments at 4, 8, and 12months. We used latent growth curve modeling techniques to analyze the data. Results showed that while all participants exhibited reductions in depression, meth use, and condomless sex, the intervention and comparison groups did not differ in changes over time. However, we did find a significant gender moderation effect, such that among men, those in the intervention arm reported greater reductions in meth use relative to those in the comparison group; reduced meth use was associated with reduced condomless sex, but not depression. In contrast, women in the intervention condition did not differ from women in the comparison condition in changes in any of the three outcome variables. Interventions targeting heterosexual women and men who use meth must be gender-specific, and take into account the unique vulnerabilities and experiences of women, including the perceived positive aspects of using meth, gendered power dynamics, higher depression, and violence.

What works best for whom? Cognitive Behavior Therapy and Mindfulness-Based Cognitive Therapy for depressive symptoms in patients with diabetes.

ObjectiveCognitive Behavior Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) have shown to be effective interventions for treating depressive symptoms in patients with diabetes. However, little is known about which intervention works best for whom (i.e., moderators of efficacy). The aim of this study was to identify variables that differentially predicted response to either CBT or MBCT (i.e., prescriptive predictors).MethodsThe sample consisted of 91 adult outpatients with type 1 or type 2 diabetes and comorbid depressive symptoms (i.e., BDI-II ≥ 14) who were randomized to either individual 8-week CBT (n = 45) or individual 8-week MBCT (n = 46). Patients were followed for a year and depressive symptoms were measured at pre-treatment, post-treatment, and at 9-months follow-up. The predictive effect of demographics, depression related characteristics, and disease specific characteristics on change in depressive symptoms was assessed by means of hierarchical regression analyses.ResultsAnalyses showed that education was the only factor that differentially predicted a decrease in depressive symptoms directly after the interventions. At post-treatment, individuals with higher educational attainment responded better to MBCT, as compared to CBT. Yet, this effect was not apparent at 9-months follow-up.ConclusionsThis study did not identify variables that robustly differentially predicted treatment effectiveness of CBT and MBCT, indicating that both CBT and MBCT are accessible interventions that are effective for treating depressive symptoms in broad populations with diabetes. More research is needed to guide patient-treatment matching in clinical practice.

Age of Drinking Initiation as a Moderator of the Efficacy of a Brief, Web-Based Personalized Feedback Alcohol Intervention

ABSTRACTEarly initiation of alcohol use is associated with high-risk drinking and an increased risk of adult alcohol dependence. The current study tested age of drinking initiation as a moderator of the efficacy of a brief, Web-based intervention on frequency of drinking and alcohol-related consequences among ninth-grade students (N = 513). At a three-month follow-up, students in the intervention group reported a reduction in drinking frequency and alcohol-related consequences relative to those in the control group. In addition, age of drinking initiation was a significant moderator of intervention efficacy. Intervention effects were greatest among two groups of students—those who reported abstinence at baseline and those who initiated drinking at age 11 or younger. Results support a brief, Web-based intervention as a promising strategy for reducing frequency of drinking and the associated consequences as a prevention strategy for students who report no drinking history and as an intervention strategy for early initiators who are at the highest risk for developing alcohol-related problems.

Evaluating potential moderators of efficacy for a single-session computer-delivered 5As intervention for smoking in pregnancy

Evaluating potential moderators of efficacy for a single-session computer-delivered 5As intervention for smoking in pregnancy

Does stage tailoring matter in brief alcohol interventions for job-seekers? A randomized controlled trial.

To investigate whether or not a stage tailored intervention is more effective than a non-stage tailored intervention of the same intensity in reducing alcohol use among job-seekers with unhealthy alcohol use, and whether initial motivation to change is a moderator of efficacy. A three-group randomized controlled trial with 3-, 6- and 15-month follow-ups. Three job agencies in Germany. A total of 1243 job-seekers with unhealthy alcohol use were randomized to (i) stage tailored intervention based on the transtheoretical model of change (ST), (ii) non-stage tailored intervention based on the theory of planned behaviour (NST) and (iii) assessment only (controls). Participants received feedback letters and manuals at baseline and 3 months later. Piecewise latent growth models were calculated measuring change in 'alcohol use' from baseline to month 3 (active intervention phase) and from months 3 to 15 (post-intervention phase, primary outcome). Motivation to change was included as a 4-point continuous measure. All groups reduced alcohol use from months 0 to 3 (controls: mean = -0.866, NST: mean = -0.883, ST: mean = -0.718, Ps ≤ 0.001). Post-intervention (months 3-15), low-motivated individuals in the ST group showed a greater reduction than those in the control group (β = 0.135, P = 0.039, Cohen's d = 0.42) and in the NST group (β = 0.180, P = 0.009, Cohen's d = 0.55). In contrast, compared to the ST group (β = 0.030, P = 0.361), alcohol use decreased more strongly with higher initial motivation in the NST group (β = -0.118, P = 0.010). Among job-seekers with high levels of alcohol consumption, an intervention tailored to motivational 'stage of change' was more effective than a non-stage tailored intervention for reducing alcohol use 15 months after baseline assessment in participants with low initial motivation to change.