scholarly journals Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
John Powell ◽  
Veronika Williams ◽  
Helen Atherton ◽  
Kylie Bennett ◽  
Yaling Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Social Anxiety ◽  
General Population ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Anxiety Symptoms ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Self Help

BACKGROUND Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population, and many people with symptoms do not seek help for what represents a significant public health problem. OBJECTIVE This study aimed to evaluate the effectiveness of a self-guided cognitive behavioral internet intervention for people with social anxiety symptoms in the general population. METHODS We conducted a two-group randomized controlled trial in England between May 11, 2016, and June 27, 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a Web-based unguided self-help intervention based on cognitive behavioral principles or a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all time points (6 weeks, 3 months, 6 months, and 12 months). RESULTS A total of 2122 participants were randomized, and 6 were excluded from analyses because they were ineligible. Of the 2116 eligible randomized participants (mean age 37 years; 80.24%, 1698/2116 women), 70.13% (1484/2116) had follow-up data available for analysis, and 56.95% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm. At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was −1.94 (−3.13 to −0.75; <italic>P</italic>=.001), a standardized mean difference effect size of 0.2. The improvement was maintained at 12 months. Given the high dropout rate, sensitivity analyses explored missing data assumptions, with results that were consistent with those of the primary analysis. The economic evaluation demonstrated cost-effectiveness with a small health status benefit and a reduction in health service utilization. CONCLUSIONS For people with social anxiety symptoms who are not receiving other forms of help, this study suggests that the use of an online self-help tool based on cognitive behavioral principles can provide a small improvement in social anxiety symptoms compared with no intervention, although dropout rates were high. CLINICALTRIAL ClinicalTrials.gov NCT02451878; https://clinicaltrials.gov/ct2/show/NCT02451878

scholarly journals Effectiveness and Cost-Effectiveness of a Self-Guided Internet Intervention for Social Anxiety Symptoms in a General Population Sample: Randomized Controlled Trial

10.2196/16804 ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. e16804
Author(s):  
John Powell ◽  
Veronika Williams ◽  
Helen Atherton ◽  
Kylie Bennett ◽  
Yaling Yang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Social Anxiety ◽  
General Population ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Anxiety Symptoms ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Self Help

Background Many people are accessing digital self-help for mental health problems, often with little evidence of effectiveness. Social anxiety is one of the most common sources of mental distress in the population, and many people with symptoms do not seek help for what represents a significant public health problem. Objective This study aimed to evaluate the effectiveness of a self-guided cognitive behavioral internet intervention for people with social anxiety symptoms in the general population. Methods We conducted a two-group randomized controlled trial in England between May 11, 2016, and June 27, 2018. Adults with social anxiety symptoms who were not receiving treatment for social anxiety were recruited using online advertisements. All participants had unrestricted access to usual care and were randomized in a 1:1 ratio to either a Web-based unguided self-help intervention based on cognitive behavioral principles or a waiting list control group. All outcomes were collected through self-report online questionnaires. The primary outcome was the change in 17-item Social Phobia Inventory (SPIN-17) score from baseline to 6 weeks using a linear mixed-effect model that used data from all time points (6 weeks, 3 months, 6 months, and 12 months). Results A total of 2122 participants were randomized, and 6 were excluded from analyses because they were ineligible. Of the 2116 eligible randomized participants (mean age 37 years; 80.24%, 1698/2116 women), 70.13% (1484/2116) had follow-up data available for analysis, and 56.95% (1205/2116) had data on the primary outcome, although attrition was higher in the intervention arm. At 6 weeks, the mean (95% CI) adjusted difference in change in SPIN-17 score in the intervention group compared with control was −1.94 (−3.13 to −0.75; P=.001), a standardized mean difference effect size of 0.2. The improvement was maintained at 12 months. Given the high dropout rate, sensitivity analyses explored missing data assumptions, with results that were consistent with those of the primary analysis. The economic evaluation demonstrated cost-effectiveness with a small health status benefit and a reduction in health service utilization. Conclusions For people with social anxiety symptoms who are not receiving other forms of help, this study suggests that the use of an online self-help tool based on cognitive behavioral principles can provide a small improvement in social anxiety symptoms compared with no intervention, although dropout rates were high. Trial Registration ClinicalTrials.gov NCT02451878; https://clinicaltrials.gov/ct2/show/NCT02451878

A mobile app for social anxiety disorder: A three-arm randomized controlled trial comparing mobile and PC-based guided self-help interventions.

2018 ◽  
Vol 86 (6) ◽  
pp. 493-504 ◽  
Author(s):  
Timo Stolz ◽  
Ava Schulz ◽  
Tobias Krieger ◽  
Alessia Vincent ◽  
Antoine Urech ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Anxiety Disorder ◽  
Social Anxiety ◽  
Social Anxiety Disorder ◽  
Controlled Trial ◽  
Mobile App ◽  
Randomized Controlled ◽  
Self Help

scholarly journals An Internet-Based Cognitive Behavioral Therapy Program Adapted to Patients With Cardiovascular Disease and Depression: Randomized Controlled Trial

10.2196/14648 ◽  
2019 ◽  
Vol 6 (10) ◽  
pp. e14648 ◽  
Author(s):  
Peter Johansson ◽  
Mats Westas ◽  
Gerhard Andersson ◽  
Urban Alehagen ◽  
Anders Broström ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Cognitive Behavioral Therapy ◽  
Primary Outcome ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Eq Vas

Background Depression is a common cause of reduced well-being and prognosis in patients with cardiovascular disease (CVD). However, there is a lack of effective intervention strategies targeting depression. Objective The study aimed to evaluate the effects of a nurse-delivered and adapted internet-based cognitive behavioral therapy (iCBT) program aimed at reducing depression in patients with CVD. Methods A randomized controlled trial was conducted. A total of 144 patients with CVD with at least mild depression (Patient Health Questionnaire–9 [PHQ-9] score ≥5) were randomized 1:1 to a 9-week program of iCBT (n=72) or an active control participating in a Web-based discussion forum (online discussion forum [ODF], n=72). The iCBT program, which included 7 modules, was adapted to fit patients with CVD. Nurses with an experience of CVD care provided feedback and a short introduction to cognitive behavioral therapy. The primary outcome, depression, was measured using PHQ-9. Secondary outcomes were depression measured using the Montgomery-Åsberg Depression Rating Scale–self-rating version (MADRS-S), health-related quality of life (HRQoL) measured using Short Form 12 (SF-12) survey and EuroQol Visual Analogue Scale (EQ-VAS), and the level of adherence. An intention-to-treat analysis with multiple imputations was used. Between-group differences in the primary and secondary outcomes were determined by the analysis of covariance, and a sensitivity analysis was performed using mixed models. Results Compared with ODF, iCBT had a significant and moderate treatment effect on the primary outcome depression (ie, PHQ-9; mean group difference=−2.34 [95% CI −3.58 to −1.10], P<.001, Cohen d=0.62). In the secondary outcomes, compared with ODF, iCBT had a significant and large effect on depression (ie, MADRS-S; P<.001, Cohen d=0.86) and a significant and moderate effect on the mental component scale of the SF-12 (P<.001, Cohen d=0.66) and the EQ-VAS (P<.001, Cohen d=0.62). Overall, 60% (n=43) of the iCBT group completed all 7 modules, whereas 82% (n=59) completed at least half of the modules. No patients were discontinued from the study owing to a high risk of suicide or deterioration in depression. Conclusions Nurse-delivered iCBT can reduce depression and improve HRQoL in patients with CVD, enabling treatment for depression in their own homes and at their preferred time. Trial Registration ClinicalTrials.gov NCT02778074; https://clinicaltrials.gov/ct2/show/NCT02778074

scholarly journals CCT: continuous care trial - a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Adrie Lettink ◽  
Karina Chaibekava ◽  
Luc Smits ◽  
Josje Langenveld ◽  
Rafli van de Laar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
Epidural Analgesia ◽  
Maternity Care ◽  
Primary Outcome ◽  
Impact Analysis ◽  
Budget Impact ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Continuous Care

Abstract Background In 2009, the Steering Committee for Pregnancy and Childbirth in the Netherlands recommended the implementation of continuous care during labor in order to improve perinatal outcomes. However, in current care, routine maternity caregivers are unable to provide this type of care, resulting in an implementation rate of less than 30%. Maternity care assistants (MCAs), who already play a nursing role in low risk births in the second stage of labor and in homecare during the postnatal period, might be able to fill this gap. In this study, we aim to explore the (cost) effectiveness of adding MCAs to routine first- and second-line maternity care, with the idea that these MCAs would offer continuous care to women during labor. Methods A randomized controlled trial (RCT) will be performed comparing continuous care (CC) with care-as-usual (CAU). All women intending to have a vaginal birth, who have an understanding of the Dutch language and are > 18 years of age, will be eligible for inclusion. The intervention consists of the provision of continuous care by a trained MCA from the moment the supervising maternity caregiver establishes that labor has started. The primary outcome will be use of epidural analgesia (EA). Our secondary outcomes will be referrals from primary care to secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women’s satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis. Cost effectiveness will be calculated by QALY per prevented EA based on the utility index from the EQ-5D and the usage of healthcare services. A standardized sensitivity analysis will be carried out to quantify the outcome in addition to a budget impact analysis. In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992). Discussion We expect that adding MCAs to the routine maternity care team will result in a decrease in the use of epidural analgesia and subsequent costs without a reduction in patient satisfaction. It will therefore be a cost-effective intervention. Trial registration Trial Registration: Netherlands Trial Register, NL8065. Registered 3 October 2019 - Retrospectively registered.

scholarly journals Efficacy of an unguided internet‐based self‐help intervention for social anxiety disorder in university students: A randomized controlled trial

2019 ◽  
Vol 28 (2) ◽  
pp. e1766 ◽  
Author(s):  
Fanny Kählke ◽  
Thomas Berger ◽  
Ava Schulz ◽  
Harald Baumeister ◽  
Matthias Berking ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Anxiety Disorder ◽  
Social Anxiety ◽  
University Students ◽  
Social Anxiety Disorder ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Self Help

Adding a smartphone app to internet-based self-help for social anxiety: A randomized controlled trial

2018 ◽  
Vol 87 ◽  
pp. 98-108 ◽  
Author(s):  
Johanna Boettcher ◽  
Kristoffer Magnusson ◽  
Arvid Marklund ◽  
Ellinor Berglund ◽  
Rikard Blomdahl ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Anxiety ◽  
Controlled Trial ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Self Help

scholarly journals Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Victoria Ka-Ying Hui ◽  
Christy Yim-Fan Wong ◽  
Eric Ka-Yiu Ma ◽  
Fiona Yan-Yee Ho ◽  
Christian S. Chan
Keyword(s):  
Randomized Controlled Trial ◽  
Hong Kong ◽  
Major Depression ◽  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Cognitive Behavioral ◽  
Randomized Controlled ◽  
Self Help

Abstract Background Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. Methods A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. Discussion It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. Trial registration ClinicalTrials.gov NCT04228146. Retrospectively registered on 14 January 2020.

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