scholarly journals The association between usage and outcomes of an online intervention for depression: how optimal dosage can help establish adherence (Preprint)

2018 ◽  
Author(s):  
Angel Enrique Roig ◽  
Jorge Palacios ◽  
Holly Ryan ◽  
Derek Richards
Keyword(s):  
Behavioral Therapy ◽  
Controlled Trial ◽  
Community Sample ◽  
Secondary Analysis ◽  
Optimal Dose ◽  
Program Completion ◽  
Optimal Dosage ◽  
Internet Interventions ◽  
The Relationship ◽  
Usage Metrics

BACKGROUND Internet interventions are able to easily generate objective data about program usage. Increasingly, more studies are exploring the relationship between usage and outcomes but they often report different metrics of use and the findings are mixed. Thus, current evaluations fail to demonstrate which metrics should be considered and if it is possible to determine an optimal dose-response relationship which can inform thresholds for adherence and clinically meaningful change. OBJECTIVE This study aimed to explore the relationship between several usage metrics and outcomes; and determine an optimal dose of usage of an internet intervention for depression. METHODS This is a secondary analysis of data from a Randomized Controlled Trial that examined the efficacy of an internet-based Cognitive-Behavioral Therapy (iCBT) program for depression (Space from Depression) in an adult community sample. Space from Depression is a seven-module, supported intervention delivered over a period of 8 weeks. Supporters were trained volunteers who provided feedback to participants on a weekly basis. Different usage metrics (i.e. time spent, modules and activities completed, percentage of program completion) were automatically collected by the platform and composite variables from these (e.g. activities per session) were computed. A breakdown of the usage metrics was obtained by weeks. For the analysis, the sample was divided into those who obtained a reliable change (RC) (Beck Depression Inventory [BDI-II] change >8) and those who did not. RESULTS Data from 216 users who used the intervention and completed pre and post-treatment outcomes were included in the analyses. 89 participants obtained a RC and 127 did not. Those in the RC group significantly spent more time, had more logins, used more tools, viewed a higher percentage of the program and got more reviews from the supporter compared to those who did not obtain a RC. Differences between groups in usage was observed from first week in advance across the different metrics although they vanished over time. In the RC group, the usage was higher during the first four weeks and then a significant decrease was observed. ROC Curve analyses showed that the optimal cut-points for different usage metrics were 7 hours total time spent, 15 sessions, 30 tools used and 50% of program completion. CONCLUSIONS Overall, the results showed that those individuals who obtained RC after the intervention had higher levels of exposure to the platform. The usage during the first half of the intervention was higher and differences between groups were observed from the first week. This study also suggests that it is possible to determine an optimal dose and this can be used to inform the minimal usage to establish adherence. These results will help to better understand how to use internet interventions and what optimal level of engagement can most affect outcomes. CLINICALTRIAL The trial is registered as a controlled trial with ISRCTN (ISRCTN03704676).

scholarly journals Exploring the Relationship Between Usage and Outcomes of an Internet-Based Intervention for Individuals With Depressive Symptoms: Secondary Analysis of Data From a Randomized Controlled Trial

10.2196/12775 ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. e12775 ◽  
Author(s):  
Angel Enrique ◽  
Jorge E Palacios ◽  
Holly Ryan ◽  
Derek Richards
Keyword(s):  
Randomized Controlled Trial ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Community Sample ◽  
Secondary Analysis ◽  
Program Completion ◽  
Randomized Controlled ◽  
The Relationship ◽  
Internet Based Intervention ◽  
Usage Metrics

Background Internet interventions can easily generate objective data about program usage. Increasingly, more studies explore the relationship between usage and outcomes, but they often report different metrics of use, and the findings are mixed. Thus, current evaluations fail to demonstrate which metrics should be considered and how these metrics are related to clinically meaningful change. Objective This study aimed to explore the relationship between several usage metrics and outcomes of an internet-based intervention for depression. Methods This is a secondary analysis of data from a randomized controlled trial that examined the efficacy of an internet-based cognitive behavioral therapy for depression (Space from Depression) in an adult community sample. All participants who enrolled in the intervention, regardless of meeting the inclusion criteria, were included in this study. Space from Depression is a 7-module supported intervention, delivered over a period of 8 weeks. Different usage metrics (ie, time spent, modules and activities completed, and percentage of program completion) were automatically collected by the platform, and composite variables from these (eg, activities per session) were computed. A breakdown of the usage metrics was obtained by weeks. For the analysis, the sample was divided into those who obtained a reliable change (RC)—and those who did not. Results Data from 216 users who completed pre- and posttreatment outcomes were included in the analyses. A total of 89 participants obtained an RC, and 127 participants did not obtain an RC. Those in the RC group significantly spent more time, had more log-ins, used more tools, viewed a higher percentage of the program, and got more reviews from their supporter compared with those who did not obtain an RC. Differences between groups in usage were observed from the first week in advance across the different metrics, although they vanished over time. In the RC group, the usage was higher during the first 4 weeks, and then a significant decrease was observed. Our results showed that specific levels of platform usage, 7 hours total time spent, 15 sessions, 30 tools used, and 50% of program completion, were associated with RC. Conclusions Overall, the results showed that those individuals who obtained an RC after the intervention had higher levels of exposure to the platform. The usage during the first half of the intervention was higher, and differences between groups were observed from the first week. This study also showed specific usage levels associated with outcomes that could be tested in controlled studies to inform the minimal usage to establish adherence. These results will help to better understand how to use internet-based interventions and what optimal level of engagement can most affect outcomes. Trial Registration ISRCTN Registry ISRCTN03704676; http://www.isrctn.com/ISRCTN03704676 International Registered Report Identifier (IRRID) RR2-10.1186/1471-244X-14-147

scholarly journals Effect of vitamin B6 supplementation, in combination with magnesium, on severe stress and magnesium status: secondary analysis from an RCT

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Lionel Noah ◽  
Gisèle Pickering ◽  
Claude Dubray ◽  
Andre Mazur ◽  
Simon Hitier ◽  
...  
Keyword(s):  
General Population ◽  
Vitamin B6 ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Subscale Score ◽  
Normal Range ◽  
Parallel Group ◽  
Stress Score ◽  
Randomised Controlled ◽  
The Relationship

AbstractIntroductionEvidence from a recent randomised controlled trial1 suggests that in severely stressed subjects with low magnesemia, supplementation with magnesium (Mg) in combination with vitamin B6 (B6) provides greater benefits than Mg alone. B6 was reported to facilitate Mg absorption and its cellular uptake and to exert synergistic effect with Mg. The current secondary analysis explored the relationship between Mg-B6 combination and erythrocyte Mg concentration, used as a biomarker of body Mg status.Material and MethodsAn 8-week, Phase IV, controlled, single-blinded, parallel-group trial (EudraCT Number 2015-003749-24) stratified by sex was conducted in adults (n = 264) with a Depression Anxiety Stress Scales - stress subscale score (DASS-42SS) > 18 and serum Mg of 0.5–0.85mmol/L, randomised 1:1 to daily oral Mg-B6 (Magne B6®, Mg 300 mg; B6 30mg) or oral Mg alone (Magnespasmyl®, Mg 300mg). Outcomes were stress score, serum Mg (mmol/L), erythrocytes Mg (mmol/L), and serum B6 (nmol/L) from baseline to Week4 and Week8. Data are given as mean(SD) values.Results & DiscussionBaseline characteristics. Baseline magnesemia was 0.80(0.04) for both groups. Erythrocyte Mg concentration for the lower quintile of the studied population (n = 53) was 0.73–1.62, below the normal range of 1.65–2.65 in general population. The mean stress score in this subgroup was higher [29.5(6.3)], but not significantly different from that in other quintiles [lowest value: 26.1(7.6)]. Baseline B6 serum level for the lower B6 quintile (5–23), below the normal range for general population, was suggestive of possible B6 deficiency.Treatment effects. Both treatments increased slightly but not significantly erythrocyte Mg level from baseline to Week8 [1.84(0.03) to 1.86(0.03), and 1.86(0.03) to 188(0.03), respectively for Mg + B6 and Mg groups]. Significant changes were observed in subjects with low erythrocyte Mg level at baseline (< 1.6), namely an increase of + 0.13(0.04–0.22) for Mg + B6 and + 0.17(0.08–0.25) for Mg groups, but with no difference between treatments. Moreover, Mg + B6 supplementation led to a significant change (p < 0.0001) in serum B6 level between baseline and Wk8 [55.9(4.8) to 370.9(11.3)], as compared to Mg alone [51.9(4.8) to 51.5(11.3)].In conclusion, both treatments significantly increased erythrocyte Mg in subjects with low Mg status. B6 supplementation did not lead to further increase in erythrocyte Mg level. We have previously shown that severely stressed population benefits from B6 supplementation in combination with Mg, however, the mechanism of the interaction between Mg and B6 remains to be elucidated.1Sponsored by Sanofi

scholarly journals The Effect of Adjunctive Mangosteen Pericarp on Cognition in People With Schizophrenia: Secondary Analysis of a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Wolfgang Marx ◽  
David R. Skvarc ◽  
Mohammadreza Mohebbi ◽  
Adam J. Walker ◽  
Alcy Meehan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Visual Learning ◽  
Secondary Analysis ◽  
Cognitive Outcomes ◽  
Garcinia Mangostana ◽  
Cognitive Domains ◽  
Optimal Dosing ◽  
Dosing Strategies ◽  
The Relationship

Background: Cognitive impairment is prevalent and often highly burdensome in people with schizophrenia. The aim of this study was to investigate if mangosteen (Garcinia mangostana Linn.) pericarp extract may be an effective intervention to improve cognitive performance in this population.Methods: This was a secondary analysis of a larger randomized placebo-controlled trial that investigated a 24-weeks intervention of mangosteen pericarp extract supplementation in people diagnosed with schizophrenia. A subset of n = 114 participants with completed cognitive outcomes at follow up were included in this analysis. Using the Cogstate Brief Battery, the following cognitive outcomes were assessed: psychomotor function, attention, visual learning and memory (visual and working). Subgroup analyses investigated whether baseline clinical parameters (baseline cognitive functioning, illness severity and duration, depressive symptoms) moderated the relationship between mangosteen pericarp extract intervention and change in cognitive outcomes.Results: There were no significant between-group changes in any cognitive outcomes assessed. Subgroup analysis based on baseline cognition and clinical characteristics did not reveal any significant between-group difference in change.Conclusions: Mangosteen pericarp extract did not affect cognitive outcomes in people with schizophrenia. Further investigation regarding optimal dosing strategies for mangosteen interventions and the testing of additional cognitive domains may be warranted.Trial Registration:ANZCTR.org.au identifier: ACTRN12616000859482, registered 30 June 3 2016.

scholarly journals Are Changes in Beliefs About Rumination and in Emotion Regulation Skills Mediators of the Effects of Internet-Delivered Cognitive-Behavioral Therapy for Depression and Anxiety? Results from a Randomized Controlled Trial

2021 ◽  
Author(s):  
Angel Enrique ◽  
Nora Eilert ◽  
Rebecca Wogan ◽  
Caroline Earley ◽  
Daniel Duffy ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Depression And Anxiety ◽  
Expressive Suppression ◽  
Mediation Analyses ◽  
Face To Face ◽  
Symptoms Of Depression ◽  
Trial Testing

Abstract Background Internet-delivered cognitive behavior therapy (iCBT) is effective in treating anxiety and depression. Research on how these interventions operate is scarce. This study explored whether emotion regulation skills and positive beliefs about rumination were affected by iCBT and if these constructs mediated changes in depression and anxiety. Methods This is a secondary analysis of a pragmatic randomized waitlist-controlled trial testing the effectiveness of supported iCBT. Adults with at least mild symptoms of depression or anxiety were included. Depression (PHQ-9), anxiety (GAD-7), positive beliefs about rumination (PBRS-A) and two emotion regulation skills: cognitive reappraisal (ERQ-A) and expressive suppression (ERQ-S), were measured at baseline and 8-weeks post-treatment. Results The analyses included 358 participants, 71% were female. Median age was 29. Linear mixed models showed statistically significant differences along ERQ-A in favor of the iCBT group (b = 1.83, SE = 0.82, p = .026). Mediation analyses showed reductions in depression (b = 0.31, SE = 0.15, p = 0.043) and anxiety symptoms (b = 0.27, SE = 0.14, p = 0.057) were partially mediated by gains in ERQ-A. No effects were observed for PBRS-A and ERQ-S. Conclusions These results align with findings from face-to-face therapy and add to the scarce literature on mediators of effects of iCBT, contributing to the understanding of how these interventions operate. Since mediator and outcome variables were measured at the same time, partial mediation results should be interpreted with caution since the study design did not account for temporality and therefore causality effects cannot be confirmed. Trial Registration ISRCTN91967124.

scholarly journals Cognitive and Behavioral Skills Exercises Completed by Patients with Major Depression During Smartphone Cognitive Behavioral Therapy: Secondary Analysis of a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Toshi A Furukawa ◽  
Masaru Horikoshi ◽  
Hirokazu Fujita ◽  
Naohisa Tsujino ◽  
Ran Jinnin ◽  
...  
Keyword(s):  
Behavioral Activation ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cognitive Restructuring ◽  
Cognitive Behavioral ◽  
Depression Severity ◽  
Behavioral Skills ◽  
Self Monitoring ◽  
Randomized Controlled

BACKGROUND A strong and growing body of evidence has demonstrated the effectiveness of cognitive behavioral therapy (CBT), either face-to-face, in person, or as self-help via the Internet, for depression. However, CBT is a complex intervention consisting of several putatively effective components, and how each component may or may not contribute to the overall effectiveness of CBT is poorly understood. OBJECTIVE The aim of this study was to investigate how the users of smartphone CBT use and benefit from various components of the program. METHODS This is a secondary analysis from a 9-week, single-blind, randomized controlled trial that has demonstrated the effectiveness of adjunctive use of smartphone CBT (Kokoro-App) over antidepressant pharmacotherapy alone among patients with drug-resistant major depressive disorder (total n=164, standardized mean difference in depression severity at week 9=0.40, J Med Internet Res). Kokoro-App consists of three cognitive behavioral skills of self-monitoring, behavioral activation, and cognitive restructuring, with corresponding worksheets to fill in. All activities of the participants learning each session of the program and completing each worksheet were uploaded onto Kokoro-Web, which each patient could use for self-check. We examined what use characteristics differentiated the more successful users of the CBT app from the less successful ones, split at the median of change in depression severity. RESULTS A total of 81 patients with major depression were allocated to the smartphone CBT. On average, they completed 7.0 (standard deviation [SD] 1.4) out of 8 sessions of the program; it took them 10.8 (SD 4.2) days to complete one session, during which they spent 62 min (SD 96) on the app. There were no statistically significant differences in the number of sessions completed, time spent for the program, or the number of completed self-monitoring worksheets between the beneficiaries and the nonbeneficiaries. However, the former completed more behavioral activation tasks, engaged in different types of activities, and also filled in more cognitive restructuring worksheets than the latter. Activities such as “test-drive a new car,” “go to a coffee shop after lunch,” or “call up an old friend” were found to be particularly rewarding. All cognitive restructuring strategies were found to significantly decrease the distress level, with “What would be your advice to a friend who has a similar problem?” found more helpful than some other strategies. CONCLUSIONS The CBT program offered via smartphone and connected to the remote server is not only effective in alleviating depression but also opens a new avenue in gathering information of what and how each participant may utilize the program. The activities and strategies found useful in this analysis will provide valuable information in brush-ups of the program itself and of mobile health (mHealth) in general. CLINICALTRIAL Japanese Clinical Trials Registry UMIN CTR 000013693; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000015984 (Archived by WebCite at http://www.webcitation.org/6u6pxVwik)

scholarly journals DejianMind-Body Intervention on Depressive Mood of Community-Dwelling Adults: A Randomized Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Agnes S. Chan ◽  
Mei-chun Cheung ◽  
Wilson J. Tsui ◽  
Sophia L. Sze ◽  
Dejian Shi
Keyword(s):  
Positive Affect ◽  
Intervention Program ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Community Sample ◽  
Depressive Mood ◽  
Community Dwelling ◽  
Self Report ◽  
Control Group ◽  
Psychological Therapies

The present study evaluated the effectiveness of a short-term mind-body intervention program on improving the depressive mood of an adult community sample. Forty adult volunteers with various degrees of depressive mood were randomly assigned to the experimental group (DejianMind-Body Intervention, DMBI) and control group (Cognitive-Behavioral Therapy, CBT). For each group, a total of four 90-min weekly sessions were conducted. Treatment-related changes were measured using the Beck Depression Inventory (BDI-II), an electroencephalographic indicator of positive affect (i.e., prefrontal activation asymmetry), and self-report ratings on physical health. Results indicated that both the DMBI and the CBT group demonstrated significant reduction in depressive mood. However, among individuals with moderate to severe depressive mood at baseline, only those in the DMBI but not the CBT group showed significant reduction in depressive mood. Besides, only the DMBI group demonstrated a significant increase in prefrontal activation asymmetry, suggesting increase in positive affect. While most psychological therapies for depressive mood normally take several months to show treatment effect, the present findings provided initial data suggesting that the DMBI was effective in improving depressive mood of community adults after 1 month of training.

Sign in / Sign up

Export Citation Format

Share Document