scholarly journals Effects of an Eight Week Online intervention for Depression, Anxiety and Stress in a university sample; randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Paul Ritvo ◽  
Farah Ahmad ◽  
Christo El Morr ◽  
Meysam Pirbaglou ◽  
Rahim Moineddin
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Psychological Characteristics ◽  
Secondary Outcome ◽  
Group Differences ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact ◽  
Labor Strike

BACKGROUND University students are experiencing higher levels of distress and mental health disorder. In addressing mental health needs, web-based interventions have shown increasing promise to overcome geographic distances and high student-to-counselor ratios, with a potential for widespread implementation. The Mindfulness Virtual Community (MVC) program, a web based program, guided by mindfulness and cognitive behavioural therapy principles, is among such efforts to effectively and efficiently reduce symptoms of depression, anxiety, and stress in students. OBJECTIVE To evaluate the efficacy of an 8-week MVC program in a 2 arm randomized controlled trial (RCT) in reducing depression, anxiety, and stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a Canadian university. Guided by two prior RCTs that each demonstrated efficacy when administered during regular university operations, the current study coincided with a university-wide labor strike. Given widespread closures as a result of COVID-19, student response to online mental health programming on a disrupted campus can provide useful information for anticipating the impact of COVID-19 related disruptions METHODS In this parallel arm RCT, 154 students were randomly allocated to the 8-week MVC intervention (n= 76) or a waitlist control (WLC) condition (n= 78). The intervention included (1) educational and mindfulness video modules, (2) anonymous peer-peer discussions, and (3) anonymous, group-based, professionally guided, videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR(1) covariance structure were used to evaluate the impact of intervention, with outcome evaluations performed on both an intention to treat (ITT) and per protocol (PP) basis. RESULTS Participants (n= 154) were 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic-psychological characteristics across the MVC-WLC groups. Results under both ITT and PP approaches indicated significant between group differences for PSS (ITT: β= -2.31, P= .03; PP: β= -2.38, P= .03), but no significant between group differences in PHQ-9 (ITT: β= -0.44, P= 0.64; PP: β= -0.62, P= .053), BAI (ITT: β= -2.06, P= .31; PP: β= -2.32, P= .27), and FFMQ-SF (ITT: β= 1.33, P= .43; PP: β= 1.44, P= .41) (compared to WLC). CONCLUSIONS Under university labor strike conditions, the MVC program led to statistically significant reductions in PSS compared to WLC, but no other significant between group differences. Comparisons are made with previous study waves, undertaken during non-disrupted university conditions, where efficacy was demonstrated across depression, anxiety and mindfulness outcomes, are discussed. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

The Impact of Web-Based HOT (Healthy Outcomes for Teens) Project on Risk for Type 2 Diabetes: A Randomized Controlled Trial

2014 ◽  
Vol 16 (12) ◽  
pp. 846-852 ◽  
Author(s):  
Henna Muzaffar ◽  
Darla M. Castelli ◽  
Jane Scherer ◽  
Karen Chapman-Novakofski
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Web Based ◽  
Randomized Controlled ◽  
The Impact

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

scholarly journals Long-Term Smoking Cessation Outcomes for Sexual Minority Versus Nonminority Smokers in a Large Randomized Controlled Trial of Two Web-Based Interventions

2019 ◽  
Vol 22 (9) ◽  
pp. 1596-1604
Author(s):  
Jaimee L Heffner ◽  
Kristin E Mull ◽  
Noreen L Watson ◽  
Jennifer B McClure ◽  
Jonathan B Bricker
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Treatment Outcomes ◽  
Sexual Minority ◽  
Controlled Trial ◽  
Web Based ◽  
Psychosocial Profile ◽  
Randomized Controlled ◽  
Quit Smoking ◽  
Baseline Characteristics

Abstract Introduction Despite greater smoking prevalence among sexual minority (SM) individuals relative to non-SM individuals, minimal research has examined whether SM smokers have differential success at quitting, and no prior treatment studies have examined differences within SM subgroups. There is also limited knowledge of the psychosocial characteristics of treatment-seeking SM smokers, which could inform targeted treatments. To address these gaps, we compared treatment outcomes and baseline characteristics for SM and non-SM smokers and for bisexual versus lesbian or gay smokers in a large randomized controlled trial of two web-based cessation treatments. Methods Trial participants completed a survey to assess baseline characteristics, including self-identification as either SM (n = 253; lesbian or gay, n = 122; bisexual, n = 131) or non-SM (n = 2384). The primary cessation outcome was complete-case, self-reported 30-day abstinence at 12 months after randomization. Results Cessation outcomes did not differ significantly for SM versus non-SM smokers (24% vs. 25%, adjusted OR = 0.91, 95% CI = 0.65 to 1.28) or across SM subgroups (24% for bisexual vs. 23% for lesbian or gay, adjusted OR = 1.01, 95% CI = 0.51 to 2.00), and there were no interactions with treatment group assignment. At baseline, SM smokers differed from non-SM smokers on most demographics, were more likely to screen positive for all mental health conditions assessed, and had greater exposure to other smokers in the home. Conclusions Substantial differences in baseline characteristics of SM versus non-SM smokers and bisexual versus lesbian or gay smokers did not translate into differential treatment outcomes. Nonetheless, SM smokers’ willingness or ability to quit smoking could be enhanced by taking their unique psychosocial profile into account when designing targeted interventions. Implications The findings of this study, which included the largest sample of SM smokers in a prospective intervention trial to date, support those of a small extant body of literature showing no differences in treatment-assisted cessation outcomes between SM and non-SM smokers. Regardless of their quit rates relative to non-SM smokers, SM smokers’ willingness or ability to quit smoking could potentially be enhanced by taking their unique psychosocial profile into account in intervention design, including their younger age, lower socioeconomic status, greater likelihood of being racial or ethnic minorities, and greater prevalence of mental health symptoms.

Scapular exercise combined with cognitive functional therapy is more effective at reducing chronic neck pain and kinesiophobia than scapular exercise alone: a randomized controlled trial

2020 ◽  
Vol 34 (12) ◽  
pp. 1485-1496 ◽  
Author(s):  
Norollah Javdaneh ◽  
Amir Letafatkar ◽  
Sadredin Shojaedin ◽  
Malihe Hadadnezhad
Keyword(s):  
Randomized Controlled Trial ◽  
Neck Pain ◽  
Pain Intensity ◽  
Effect Size ◽  
Controlled Trial ◽  
Chronic Neck Pain ◽  
Secondary Outcome ◽  
Group Differences ◽  
Functional Therapy ◽  
Randomized Controlled

Objective: The aim of this study was to compare the effectiveness of scapular exercises alone and combined with cognitive functional therapy in treating patients with chronic neck pain and scapular downward rotation impairment. Design: Single-blind randomized controlled trial. Setting: Outpatient. Subjects: A total of 72 patients (20–45 years old) with chronic neck pain were studied. Intervention: Allocation was undertaken into three groups: scapular exercise ( n = 24), scapular exercise with cognitive functional therapy ( n = 24) and control ( n = 24) groups. Each programme lasted three times a week for six weeks. Main outcomes: The primary outcome measure was pain intensity measured by the visual analogue scale scores. The secondary outcome measures included kinesiophobia and muscles activity. Results: Statistically significant differences in pain intensity were found when multidisciplinary physiotherapy group including a cognitive functional approach was compared with the scapular exercise alone group at six weeks (effect size (95% CI) = −2.56 (−3.32 to −1.80); P = 0.019). Regarding kinesiophobia, a significant between-group difference was observed at six-week (effect size (95% CI) = −2.20 (−2.92 to −1.49); P = 0.005), with the superiority of effect in multidisciplinary physiotherapy group. A significant between-group differences was observed in muscle activity. Also, there were significant between-group differences favouring experimental groups versus control. Conclusion: A group-based multidisciplinary rehabilitation programme including scapular exercise plus cognitive functional therapy was superior to group-based scapular exercise alone for improving pain intensity, kinesiophobia and muscle activation in participants with chronic neck pain.

scholarly journals Protocol for an app-based affective control training for adolescents: proof-of-principle double-blind randomized controlled trial

2019 ◽  
Vol 4 ◽  
pp. 91
Author(s):  
Susanne Schweizer ◽  
Jovita T. Leung ◽  
Rogier Kievit ◽  
Maarten Speekenbrink ◽  
William Trender ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Matching Task ◽  
Double Blind ◽  
Randomized Controlled ◽  
The Impact ◽  
Proof Of Principle

Background: 75% of all mental health problems have their onset before the end of adolescence. Therefore, adolescence may be a particularly sensitive time period for preventing mental health problems. Affective control, the capacity to engage with goal relevant and inhibit distracting information in affective contexts, has been proposed as a potential target for prevention. In this study, we will explore the impact of improving adolescents’ affective control capacity on their mental health. Methods: The proof-of-principle double-blind randomized controlled trial will compare the effectiveness of an app-based affective control training (AC-Training) to a placebo training (P-Training) app. In total, 200 (~50% females) adolescents (11-19 years) will train for 14 days on their training app. The AC-Training will include three different n-back tasks: visuospatial, auditory and dual (i.e., including both modalities). These tasks require participants to flexibly engage and disengage with affective and neutral stimuli (i.e., faces and words). The P-Training will present participants with a perceptual matching task. The three versions of the P-Training tasks vary in the stimuli included (i.e., shapes, words and faces). The two training groups will be compared on gains in affective control, mental health, emotion regulation and self-regulation, immediately after training, one month and one year after training. Discussion: If, as predicted, the proposed study finds that AC-Training successfully improves affective control in adolescents, there would be significant potential benefits to adolescent mental health. As a free app, the training would also be scalable and easy to disseminate across a wide range of settings. Trial registration: The trial was registered on December 10th 2018 with the International Standard Randomised Controlled Trial Number (Registration number: ISRCTN17213032).

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