scholarly journals Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial

2021 ◽  
pp. 1-12
Author(s):  
Marianna Purgato ◽  
Kenneth Carswell ◽  
Federico Tedeschi ◽  
Ceren Acarturk ◽  
Minna Anttila ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Asylum Seekers ◽  
Western Europe ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Self Help ◽  
Refugees And Asylum Seekers

<b><i>Introduction:</i></b> Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress. <b><i>Objective:</i></b> To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe. <b><i>Methods:</i></b> We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes. <b><i>Results:</i></b> Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer <i>V</i> = 0.007, <i>p</i> = 0.90, RR = 0.96; 95% CI 0.52–1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer <i>V</i> = 0.13, <i>p</i> = 0.01, RR = 0.50; 95% CI 0.29–0.87). <b><i>Conclusions:</i></b> This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

scholarly journals Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Feng Bin Lin ◽  
◽  
Shi Da Chen ◽  
Yun He Song ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intraocular Pressure ◽  
High Myopia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rank Test ◽  
Inner Plexiform Layer ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

Feasibility and effectiveness of activity-scheduling as a guided self-help intervention for the prevention of depression and anxiety in residents in homes for the elderly: a pragmatic randomized controlled trial

2011 ◽  
Vol 23 (6) ◽  
pp. 969-978 ◽  
Author(s):  
Els Dozeman ◽  
Digna J. F. van Schaik ◽  
Harm W. J. van Marwijk ◽  
Max L. Stek ◽  
Aartjan T. F. Beekman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Depression Scale ◽  
Secondary Outcome ◽  
Depression And Anxiety ◽  
Residential Homes ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Self Help

ABSTRACTBackground: Elderly people living in residential homes are at high risk for developing major depressive and anxiety disorders, and therefore deserve attention in terms of preventive interventions. We evaluated the feasibility and effectiveness of a guided self-help intervention for the prevention of depression and anxiety in these residents.Methods: We conducted a pragmatic randomized controlled trial in two parallel groups comparing the intervention with usual care in 14 residential homes in and surrounding the city of Amsterdam in the Netherlands. A total of 129 residents with a score of 8 or more on the Centre for Epidemiologic Studies Depression Scale (CES-D) screening instrument, who did not meet the full diagnostic criteria for disorders, and were not suffering from cognitive impairment were recruited between April 2007 and December 2008. Participants were randomized to a guided self-help intervention (n = 67) or to usual care (n = 62). The main outcome measures were improvement in the level of symptoms of depression and anxiety. The secondary outcome was improvement in participation in organized activities in the residential homes. The study is registered in de Dutch Cochrane Centre, under number ISRCTN27540731.Results: Only 21% of the participants (mean age 84.0 years (SD 6.7), 72.1% suffering from two or more chronic illnesses) completed the intervention. Although we found some large positive effect sizes on the CES-D, none of these effects was statistically significant.Conclusion: Although guided self-help may be promising in the prevention of depression and anxiety, it proved to be difficult to apply in this very old and vulnerable group of people living in residential homes.

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

Preliminary evaluation of a culturally adapted CBT-based online programme for depression and anxiety from a lower middle-income country

2021 ◽  
Vol 14 ◽  
Author(s):  
Madeeha Latif ◽  
Falahat Awan ◽  
Mirrat Gul ◽  
M. Omair Husain ◽  
M. Ishrat Husain ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Common Mental Disorders ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety And Depression ◽  
Middle Income ◽  
Randomized Controlled ◽  
Self Help ◽  
Culturally Adapted

Abstract Online cognitive behaviour therapy (CBT), self-help and guided self-help (GSH) interventions have been found to be efficacious and cost-effective for treatment of anxiety and depression, but there are limited data from low- and middle-income countries on culturally adapted digital interventions for these common mental disorders. The aim of this study was to investigate the feasibility and acceptability of an online culturally adapted CBT-based guided self-help (CaCBT-GSH) for patients with anxiety and depression in Pakistan. This randomized controlled trial recruited 39 participants from primary care in Karachi, Pakistan and randomized them to two groups. The intervention group received seven modules of CaCBT-GSH plus treatment as usual (TAU) over 12 weeks. The control group was a waitlist control plus TAU. The primary outcomes were feasibility and acceptability. Clinical outcomes included results from the Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule 2 (WHODAS 2). Assessments were carried out at baseline and at 12 weeks. All 39 individuals who met eligibility criteria for the study agreed to participate. Adherence to the intervention was excellent, with 85% (17/20) completing more than five modules. Statistically significant improvements were found in all clinical outcomes in the intervention group. This was the first trial of an online CaCBT-GSH intervention, which was found to be feasible and acceptable to Pakistani patients with anxiety and depression. CaCBT-GSH may help improve symptoms, depression, anxiety and overall functioning in this population. The results provide rationale for a larger, confirmatory randomized controlled trial of digital CaCBT-GSH. Key learning aims (1) Leveraging digital and virtual platforms to deliver psychosocial interventions may contribute to addressing the significant treatment gap in low-resource settings. (2) CBT-informed guided self-help is feasible and acceptable in the treatment of common mental disorders in Pakistan. (3) The results of this study merit a larger, appropriately powered confirmatory randomized controlled trial to determine clinical and cost effectiveness.

scholarly journals Effectiveness of a WHO self‐help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial

2022 ◽  
Vol 21 (1) ◽  
pp. 88-95
Author(s):  
Ceren Acarturk ◽  
Ersin Uygun ◽  
Zeynep Ilkkursun ◽  
Kenneth Carswell ◽  
Federico Tedeschi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Randomized Controlled ◽  
Self Help

scholarly journals An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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