scholarly journals Addressing Mood Disorder Diagnosis' Stigma With an Honest, Open, Proud (HOP)-Based Intervention: A Randomized Controlled Trial

2021 ◽  
Vol 11 ◽  
Author(s):  
Arlete Modelli ◽  
Viviane P. Candal Setti ◽  
Martinus Theodorus van de Bilt ◽  
Wagner Farid Gattaz ◽  
Alexandre Andrade Loch ◽  
...  
Keyword(s):  
Mental Illness ◽  
Mood Disorders ◽  
Coming Out ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Post Intervention ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Public Health Institutions

Introduction: The public stigma and self-stigma contribute to the dilemma of disclosing or not one's own mental illness diagnosis. Studies suggest that revealing it diminishes stress, besides helping with self-esteem. Honest, Open, Proud (HOP) is a group program that aids in the process of deciding on it, reducing its impact. Considering the relevance of this issue, the present study aimed to apply a HOP-based intervention in a group of patients diagnosed with mood disorders.Methods: A randomized controlled clinical trial was used, including 61 patients with mood disorders, of whom 31 were diagnosed with depression and 30 were diagnosed with bipolar disorder. They were randomly placed on the intervention (HOP) or the control group (unstructured psychoeducation). The evaluations occurred before (T0) and after (T1) the sessions. We administered eight scales, from which three presented relevant results: Coming Out with Mental Illness Scale (COMIS), Cognitive Appraisal of Stigma as a Stressor (CogApp), and Authenticity Scale.Results: The intervention groups (depression and bipolar) did not present a significant change regarding the decision to disclose their diagnostics. However, the depression group showed a decrease on the perception of stigma as a stressor (T0 = 0.50 vs. T1 = −1.45; p = 0.058). Improvements in post-intervention results were seen for both groups (depression and bipolar) on the Authenticity Scale—self-alienation subscale (T0 = 10.40 vs. T1 = 12.37, p = 0.058).Conclusion: Our HOP-based intervention appeared to be an important program to aid patients in facing stigma stress, showing positive effects, whether helping to diminish stress or to improve self-conscience, both of which have indirect effects on self-stigma. As it is a compact program, it can bring benefits when applying to public health institutions.

scholarly journals Effectiveness of the I2AO2 interdisciplinary programme led by nurses on metabolic syndrome and cardiovascular risk: a randomized, controlled trial

2018 ◽  
Vol 46 (6) ◽  
pp. 2202-2218
Author(s):  
V. E. Fernández-Ruiz ◽  
J. A. Paniagua-Urbano ◽  
M. Solé-Agustí ◽  
A. Ruiz-Sánchez ◽  
J. Gómez-Marín ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Cardiovascular Risk ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Long Term Effects ◽  
Anthropometric Parameters ◽  
Post Intervention ◽  
Randomized Controlled

Objective To evaluate the effectiveness of an interdisciplinary programme led by nurses in relation to metabolic syndrome (MS) and cardiovascular risk (CVR). Methods This randomized, controlled, clinical trial included 74 patients diagnosed with MS (experimental group [EG], n = 37; control group [CG], n = 37). The intervention consisted of a 12-month interdisciplinary programme (pre-test, 6 months of intervention, 12 months of intervention, and 1-year follow-up post-intervention) coordinated by nursing. Results We found a progressive and significant reduction for all clinical, biochemical, and anthropometric parameters analysed at different time points. In the EG, remission of MS by 48.1% in the short term was observed (83.8% in the medium term) and maintained at 1 year post-intervention. In the CG, the prevalence of MS increased by 2.7% from the initial evaluation to study completion. A similar trend was observed for CVR. In the EG, 100% of subjects had a moderate-low risk of CVR at 1 year post-intervention, whereas the CG had CVR in all categories. Conclusion An interdisciplinary, nurse-led programme improves participants’ metabolic and cardiovascular health, while maintaining long-term effects. Our findings suggest an important role of the professional nurse as a nexus between the patient, different professionals, and the community.

scholarly journals Long-Term Influence of Platelet-Rich Plasma (PRP) on Dental Implants after Maxillary Augmentation: Retrospective Clinical and Radiological Outcomes of a Randomized Controlled Clinical Trial

2020 ◽  
Vol 9 (2) ◽  
pp. 355 ◽  
Author(s):  
Sameh Attia ◽  
Clara Narberhaus ◽  
Heidrun Schaaf ◽  
Philipp Streckbein ◽  
Jörn Pons-Kühnemann ◽  
...  
Keyword(s):  
Dental Implants ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Long Term Results ◽  
Control Group ◽  
Iliac Crest Bone Graft ◽  
Controlled Clinical Trial ◽  
Positive Effects ◽  
Randomized Controlled

The long-term clinical and radiological outcomes of dental implants inserted in augmented bone treated with platelet-rich plasma (PRP) has not been well addressed in the literature yet. This study is based on a collection of patients from a randomized controlled trial (RCT) that did not report any short-term positive effects of PRP on bone healing after sinus lift surgery using autologous iliac crest bone graft. This study aimed to evaluate the long-term impact of PRP regarding clinical and radiological outcomes on the inserted implants in the previous RCT. For this evaluation, we considered the following variables: plaque index, probing depth, bleeding index, mobility grade, Periotest® values, and radiological bone loss. Out of 53 patients (n = 306 implants) included in the previous study we were able to reinvestigate 37 patients (n = 210 implants) in two centers (31 in Giessen, Germany and 6 in Erlangen, Germany). Clinical and radiographic parameters suggested overall healthy conditions of the peri-implant tissue. The PRP-group and the control group did not differ significantly in the majority of the parameters. The overall evaluation showed that result data of the PRP-group was inferior to the control group in 64 percent of the evaluated parameters. The present study cannot provide evidence of a positive effect of PRP on the long-term implant clinical and radiological outcomes. In fact, a tendency towards inferior long-term results in the PRP-group was detected without reaching a significant threshold. Further controlled trials need to be conducted to investigate this correlation.

scholarly journals Effect of acupuncture on menopausal vasomotor symptoms (VMS): A study protocol for a randomized controlled clinical trial

2019 ◽  
Author(s):  
Anna Bogachko ◽  
Shanshan Li ◽  
Tian Li ◽  
Xuan Yin ◽  
Ping Yin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Hot Flashes ◽  
Vasomotor Symptoms ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Acupuncture Points ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Pattern Differentiation

Abstract Background During menopause, many women are troubled by vasomotor symptoms (VMS) when hot flashes, night sweats, or both, interfere with normal daily life. Both hormone therapy (HT) and taking antidepressants are common ways to reduce VMS but they have associated health risks such as breast cancer and thromboembolic events. Acupuncture is found to be a safe treatment option to reduce VMS and recent studies have demonstrated positive results applying personalized selections of acupuncture points. Hence, we hypothesize acupuncture, according to Chinese Medicine's basic principle of pattern differentiation, can reduce both frequency and severity of VMS in menopausal women. We designed a randomized controlled trial to test the hypothesis using a wait-list group as a control group and pattern differentiation to find an optimal therapeutic treatment. Method/Design The study is a single-center, pragmatic, randomized control trial with two parallel arms, to assess the effectiveness of acupuncture in 60 women in the Shanghai international and Chinese community with peri- and postmenopausal VMS. Eligible participants will be randomly assigned into two groups on a ratio 1:1. An acupuncture group of 30 women will twice weekly receive totally 12 acupuncture treatments and we will follow their treatment response through their VMS self-rating journal entries recorded at baseline, during intervention and twice post intervention as primary outcome. A waitlisted control group will record the same self-ratings of their VMS for purposes of comparison. After the six-week wait period is over, they will receive the same 12 sessions acupuncture treatment. As a second outcome, menopause-specific quality of life indicators will be assessed at baseline and twice post intervention by all participants. Discussion If the outcome of this study confirms acupuncture to be an effective and safe management method to reduce VMS in menopausal women, we expect further investigations and trials to clinically find optimal acupuncture treating strategies.

scholarly journals Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
J. Dubreucq ◽  
M. Faraldo ◽  
M. Abbes ◽  
B. Ycart ◽  
H. Richard-Lepouriel ◽  
...  
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Cognitive Therapy ◽  
Social Functioning ◽  
Serious Mental Illness ◽  
Controlled Trial ◽  
Control Group ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Stephanie Erika Bonn ◽  
Mari Hult ◽  
Kristina Spetz ◽  
Marie Löf ◽  
Ellen Andersson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Bariatric Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Participant ◽  
Lifestyle Factors ◽  
Lifestyle Changes ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

“Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.”

2020 ◽  
pp. 026921552096505
Author(s):  
Vanessa González-Rueda ◽  
Carlos López-de-Celis ◽  
Elena Bueno-Gracia ◽  
Jacobo Rodríguez-Sanz ◽  
Albert Pérez-Bellmunt ◽  
...  
Keyword(s):  
Neck Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Chronic Neck Pain ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Primary Care Center ◽  
Randomized Controlled ◽  
Upper Cervical

Objective: To evaluate the effect of adding an Upper Cervical Translatoric Mobilization (UCTM) or an Inhibitory Suboccipital Technique (IST) to a physiotherapy treatment in the symptomatology and function of mechanical chronic neck pain patients. Design: Randomized controlled trial. Setting: Primary Care Center in Cornellà, Spain. Subjects: 78 patients (64 women), with mean age (SD) of 59.96 (13.30) years with mechanical chronic neck pain were divided in three groups: control, IST and UCTM groups. Interventions: All groups received 15 physiotherapy sessions for three weeks. The UCTM and IST groups added 5 minutes of the assigned technique during six sessions. Main measures: Neck disability index (NDI) and numeric pain rating scale (NPRS) for neck pain were measured baseline, three-weeks and 15-weeks follow-up. Results: NDI (SD) at baseline, three-weeks and 15-weeks were 11.62 (7.08), 9.65 (6.25), 7.58 (5.64) for the control group, 14.38 (6.92), 8.50 (6.11), 7.12 (4.98) for the IST group and 13.19(7.23), 5.35(6.10), 4.35(2.76) for the UCTM group. NPRS (SD) at baseline, three-weeks and 15-weeks were 58.69 (19.46), 45.19 (23.43), 44.58 (24.08) for the control group; 64.08 (19.26), 42.19 (19.69), 34 (21.14) for the IST group; and 67.65 (20.65), 36.23 (20.10), 39.85 (25.44) for the UCTM group. Conclusions: Compared with no treatment, both forms of mobilization were associated with reduced disability at three weeks, and UCTM remained better than control at 15 weeks; there were no significant differences between the two mobilization groups. Trial registration: This study was registered in Clinicaltrials.gov (NCT02832232).

scholarly journals Randomized Controlled Clinical Trial Comparing Transurethral Eneucleation and Resection of Prostate and Trans-urethral Resection of Prostate in the Management of Benign Prostatic Hyperplasia

2017 ◽  
Vol 7 (3) ◽  
pp. 216-220
Author(s):  
Md Mehedi Hasan ◽  
Samira Rahat Afroze ◽  
Muhammad Abdur Rahim ◽  
Muhammad Abdus Salam
Keyword(s):  
Controlled Trial ◽  
Ethical Review ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Transurethral Resection Of Prostate ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

Background: Transurethral resection of prostate (TURP) is the predominant surgical procedure for benign prostatic hypertension (BPH) but is not devoid of complications like capsular perforation, drop in Hb%, drop in Na+, residual adenoma; hence endeavors are evolving to combat such complications. A newer technique transurethral enucleation and resection of prostate (TUERP) has been devised to solve these problems. This study was designed to compare the safety and the efficacy of newer technique, TUERP with widely practiced TURP Methods: This randomized controlled trial was done at BSMMU, after getting ethical approval from the ethical review committee of the institute, from January to October, 2009. A total of 60 BPH patients were purposively enrolled in this study, after obtaining informed written consent and they were randomized as control, Group A (30 patients, underwent TURP) and experimental group, Group B (30 patients, underwent TEURP).Results: The mean preoperative Hb% level of Group A was 15.1 gm% (SD ± 0.5) and perioperative Hb% level was 13.04 gm% (SD ± 6.06). There was significant difference (P <0.05). The mean preoperative Hb% of Group B was 15.2 gm% (SD ± 0.5) and perioperative Hb% was 15.2 gm% (SD ± 0.48). There was no difference (P >0.05). The mean preoperative Na + of Group A was 140 mmol/l (SD ± 4.1) and perioperative Na+ was 126 mmol/l (SD ± 6.8). There was significant difference (P<0.01). The mean preoperative Na+ of Group B was 136 mmol/l (SD ± 4) and perioperative Na+ was 136 mmol/l (SD ± 2.70). There was no difference (P >0.05).Conclusion: TUERP eliminates drop in Hb% and Na+which are usual consequences following TURP. Thus TUERP can be advocated in the treatment of BPH as it also allows completeresection down to surgical capsule.Birdem Med J 2017; 7(3): 216-220

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

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