scholarly journals Internet-Delivered Cognitive Behavior Therapy for Young Taiwanese Female Nursing Students with Irritable Bowel Syndrome—A Cluster Randomized Controlled Trial

2019 ◽  
Vol 16 (5) ◽  
pp. 708 ◽  
Author(s):  
Tzu-Ying Lee ◽  
Tsung-Cheng Hsieh ◽  
Huei-Chuan Sung ◽  
Wan-Lan Chen
Keyword(s):  
Nursing Students ◽  
Controlled Trial ◽  
Anxiety And Depression ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Irritable Bowel

Irritable Bowel Syndrome (IBS) is prevalent within the general population. Studies have shown that stress and anxiety co-exist with IBS. Young Taiwanese women commonly exhibit physical and psychological health problems caused by academic stress. The purpose of our current study was to evaluate the efficacy of short-term Internet-delivered cognitive-behavioral therapy (ICBT) on female nursing students in practicum. We performed a cluster randomized controlled trial comprised of 160 participants who met the inclusion criteria, which were divided into three groups: (1) ICBT, (2) expressive writing (EW), and (3) wait-list control. Treatment interventions lasted for 6 weeks. Levels of anxiety, depression, and IBS symptoms were assessed at four time points, baseline assessment at T0, 2 weeks after T0 (T1), at the end of practicum (T2), and at 3-month follow-up (T3). The results showed that ICBT and EW groups exhibited a significant, yet small, reduction in anxiety and depression at T2 and T3 compared to the wait-list control group. The EW group exhibited significantly greater reduction in anxiety and depression compared to the ICBT group at T2. However, the ICBT group demonstrated greater improvements in alleviating anxiety and depression at T3 compared to the EW group. These data indicate that ICBT and EW groups exhibited small effects on anxiety and depression reduction at T2 and T3 compared to the wait-list control group, with no effects on IBS symptoms in young Taiwanese female nursing students.

scholarly journals A three-armed cognitive-motor exercise intervention to increase spatial orientation and life-space mobility in nursing home residents: study protocol of a randomized controlled trial in the PROfit project

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Bettina Wollesen ◽  
Madeleine Fricke ◽  
Carl-Philipp Jansen ◽  
Katharina Gordt ◽  
Michael Schwenk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Spatial Orientation ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Abstract Background In nursing home residents, the combination of decreasing mobility and declining cognitive abilities, including spatial orientation, often leads to reduced physical activity (PA) and life-space (LS) mobility. As a consequence of sedentary behavior, there is a lack of social interaction and cognitive stimulation, resulting in low quality of life. It has not yet been examined whether cognitive-motor training including spatial cognitive tasks is suitable to improve spatial orientation and, as a consequence, to enlarge LS mobility, and increase well-being and general cognitive-motor functioning. Therefore, the overall goal of this multicentric randomized controlled trial (RCT) is to compare the effect of three different intervention approaches including functional exercise and orientation tasks on PA, LS and spatial orientation in nursing home residents. Methods A three-arm single-blinded multicenter RCT with a wait-list control group will be conducted in a sample of 513 individuals (needed according to power analysis) in three different regions in Germany. In each nursing home, one of three different intervention approaches will be delivered to participating residents for 12 weeks, twice a week for 45 min each: The PROfit basic group will perform functional strength, balance, flexibility, and walking exercises always at the same location, whereas the PROfit plus group changes the location three times while performing similar/the same exercises as the PROfit basic group. The PROfit orientation group receives navigation tasks in addition to the relocation during the intervention. Physical and cognitive functioning as well as psychological measures will be assessed in all study groups at baseline. Participants will then be randomized into either the intervention group or the wait-list control group. After 12 weeks, and after 24 weeks the measures will be repeated. Discussion This study evaluates whether the three different interventions are feasible to reduce the decline of or even improve PA, LS, and spatial orientation in nursing home residents. By adding different training locations in PROfit plus, the program is expected to be superior to PROfit basic in increasing physical and cognitive parameters. Moreover, we expect the PROfit orientation intervention to be most effective in terms of PA, LS, and spatial orientation due to two mechanisms: (1) increased physical and cognitive activity will enhance cognitive-motor capacity and (2) the spatial training will help to build up cognitive strategies to compensate for age-related loss of spatial orientation abilities and related limitations. Trial registration The trial was prospectively registered at DRKS.de with registration number DRKS00021423 on April 16, 2020 and was granted permission by the Technical University Berlin local ethics committee (No. GR_14_20191217).

scholarly journals The Effectiveness of an Integrated Treatment for Functional Speech Sound Disorders—A Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (12) ◽  
pp. 1190
Author(s):  
Denise I. Siemons-Lühring ◽  
Harald A. Euler ◽  
Philipp Mathmann ◽  
Boris Suchan ◽  
Katrin Neumann
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Speech Sound ◽  
Control Group ◽  
Wait List ◽  
Speech Sound Disorders ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Randomized Controlled

Background: The treatment of functional speech sound disorders (SSDs) in children is often lengthy, ill-defined, and without satisfactory evidence of success; effectiveness studies on SSDs are rare. This randomized controlled trial evaluates the effectiveness of the integrated SSD treatment program PhonoSens, which focuses on integrating phonological and phonetic processing according to the Integrated Psycholinguistic Model of Speech Processing (IPMSP). Methods: Thirty-two German-speaking children aged from 3.5 to 5.5 years (median 4.6) with functional SSD were randomly assigned to a treatment or a wait-list control group with 16 children each. All children in the treatment group and, after an average waiting period of 6 months, 12 children in the control group underwent PhonoSens treatment. Results: The treatment group showed more percent correct consonants (PCC) and a greater reduction in phonological processes after 15 therapy sessions than the wait-list control group, both with large effect sizes (Cohen’s d = 0.89 and 1.04). All 28 children treated achieved normal phonological abilities: 21 before entering school and 7 during first grade. The average number of treatment sessions was 28; the average treatment duration was 11.5 months. Conclusion: IPMSP-aligned therapy is effective in the treatment of SSD and is well adaptable for languages other than German.

DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

2021 ◽  
pp. 136749352110037
Author(s):  
Alison E. Parker ◽  
Tracy M. Scull ◽  
Abigail M. Morrison
Keyword(s):  
Clinical Trials ◽  
Interactive Multimedia ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Satisfaction Questionnaire ◽  
Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

scholarly journals Testing the Efficacy of the Red-Light Purple-Light Games in Preprimary Classrooms in Kenya

2021 ◽  
Vol 12 ◽  
Author(s):  
Michael T. Willoughby ◽  
Benjamin Piper ◽  
Katherine Merseth King ◽  
Tabitha Nduku ◽  
Catherine Henny ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Red Light ◽  
School Type ◽  
Wait List ◽  
Intervention Period ◽  
Wait List Control ◽  
Null Results ◽  
Computerized Assessments ◽  
Randomized Controlled ◽  
Cluster Randomized

This study adapted and tested the efficacy of the Red-Light Purple-Light (RLPL) games for improving executive function (EF) skills in preprimary classrooms in Nairobi, Kenya. A cluster randomized controlled trial was used to evaluate the efficacy of the adapted RLPL intervention. Specifically, 24 centers (including 48 classrooms) were randomized to the RLPL or a wait-list control condition. Consistent with previous studies, participating classrooms delivered 16 lessons across an 8-week intervention period. A total of 479 children were recruited into the study. After exclusions based on child age and data quality, 451 and 404 children (90% retention) had completed computerized assessments of EF skills at pre- and posttest assessments, respectively. Children in the RLPL centers did not demonstrate any improvements in EF skills relative to their peers in the wait-list control condition (Cohen’s ds = −0.14 to 0.03, all ps > 0.20). Exploratory tests of moderators (language of assessment, grade, school type, baseline ability) were also all null. Results are discussed with respect to measurement limitations and contextual factors that may explain the null results of RLPL on EF skills in young children in Kenya.

scholarly journals A Randomized Trial of Yoga for Adolescents with Irritable Bowel Syndrome

2006 ◽  
Vol 11 (4) ◽  
pp. 217-224 ◽  
Author(s):  
Leora Kuttner ◽  
Christine T Chambers ◽  
Janine Hardial ◽  
David M Israel ◽  
Kevan Jacobson ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Functional Disability ◽  
Randomized Study ◽  
Gastrointestinal Symptoms ◽  
Control Group ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Yoga Intervention ◽  
Irritable Bowel

BACKGROUND: Adolescents with irritable bowel syndrome (IBS) frequently experience interference with everyday activities. Mind-body approaches such as yoga have been recommended as interventions for patients with IBS. Despite promising results among adult samples, there have been limited studies exploring the efficacy of yoga with pediatric patients.OBJECTIVE: To conduct a preliminary randomized study of yoga as treatment for adolescents with IBS.METHODS: Twenty-five adolescents aged 11 to 18 years with IBS were randomly assigned to either a yoga or wait list control group. Before the intervention, both groups completed questionnaires assessing gastrointestinal symptoms, pain, functional disability, coping, anxiety and depression. The yoga intervention consisted of a 1 h instructional session, demonstration and practice, followed by four weeks of daily home practice guided by a video. After four weeks, adolescents repeated the baseline questionnaires. The wait list control group then received the yoga intervention and four weeks later completed an additional set of questionnaires.RESULTS: Adolescents in the yoga group reported lower levels of functional disability, less use of emotion-focused avoidance and lower anxiety following the intervention than adolescents in the control group. When the pre- and postintervention data for the two groups were combined, adolescents had significantly lower scores for gastrointestinal symptoms and emotion-focused avoidance following the yoga intervention. Adolescents found the yoga to be helpful and indicated they would continue to use it to manage their IBS.CONCLUSIONS: Yoga holds promise as an intervention for adolescents with IBS.

scholarly journals Does poverty alleviation decrease depression symptoms in post-conflict settings? A cluster-randomized trial of microenterprise assistance in Northern Uganda

2016 ◽  
Vol 3 ◽  
Author(s):  
E. P. Green ◽  
C. Blattman ◽  
J. Jamison ◽  
J. Annan
Keyword(s):  
Treatment Group ◽  
Poverty Alleviation ◽  
Economic Security ◽  
Control Group ◽  
Northern Uganda ◽  
Wait List ◽  
Wait List Control Group ◽  
Wait List Control ◽  
Symptoms Of Depression ◽  
Cluster Randomized

Background.By 2009, two decades of war and widespread displacement left the majority of the population of Northern Uganda impoverished.Methods.This study used a cluster-randomized design to test the hypothesis that a poverty alleviation program would improve economic security and reduce symptoms of depression in a sample of mostly young women. Roughly 120 villages in Northern Uganda were invited to participate. Community committees were asked to identify the most vulnerable women (and some men) to participate. The implementing agency screened all proposed participants, and a total of 1800 were enrolled. Following a baseline survey, villages were randomized to a treatment or wait-list control group. Participants in treatment villages received training, start-up capital, and follow-up support. Participants, implementers, and data collectors were not blinded to treatment status.Results.Villages were randomized to the treatment group (60 villages with 896 participants) or the wait-list control group (60 villages with 904 participants) with an allocation ration of 1:1. All clusters participated in the intervention and were included in the analysis. The intent-to-treat analysis included 860 treatment participants and 866 control participants (4.1% attrition). Sixteen months after the program, monthly cash earnings doubled from UGX 22 523 to 51 124, non-household and non-farm businesses doubled, and cash savings roughly quadrupled. There was no measurable effect on a locally derived measure of symptoms of depression.Conclusions.Despite finding large increases in business, income, and savings among the treatment group, we do not find support for an indirect effect of poverty alleviation on symptoms of depression.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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