scholarly journals A Phase 1 Randomized Controlled Trial of an At-Home Positive Psychology Intervention for Individuals with Multiple Sclerosis

2020 ◽  
Author(s):  
Melanie E. Freedman ◽  
Brian C. Healy ◽  
Jeff C. Huffman ◽  
Tanuja Chitnis ◽  
Howard L. Weiner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Positive Psychology ◽  
Controlled Trial ◽  
Phase 1 ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Phone Calls ◽  
At Home

Abstract Background: Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive feelings and may improve overall well-being in medically ill populations. In this pilot study, we examined the feasibility, acceptability and potential impact of a five-week, telephone-delivered, PP intervention for individuals with multiple sclerosis (MS). Methods: Participants were randomized 1:1 to a five-week at-home PP intervention or waitlist control condition. Participants engaged in weekly phone calls with a study trainer and completed one PP exercise, such as recalling a past success, each week. Feasibility was determined by the number of sessions completed, and acceptability was assessed by weekly post-exercise participant ratings (0–10) of ease and utility. Efficacy was explored by examining between-group differences in changes from baseline on psychological variables, health-related quality of life (HRQOL), and self-reported functional activities at five and ten weeks. Results: Thirty patients enrolled in the study. Ninety-three percent of participants (n = 28) completed all exercises. Ease scores ranged from 7.7–8.7 and utility scores ranged from 8.2–8.7. The PP intervention was associated with significantly greater increases (P < .05) in positive affect, optimism, state and trait anxiety, general health, and resilience in the intervention group compared to the control group. Approximately half of the PP participants maintained ≥ 50% of the improvement at 10 weeks. Conclusions: This five-week, telephone-based PP intervention was feasible and acceptable to individuals with MS. Larger randomized controlled trials are warranted to further investigate the utility of this intervention to improve well-being and other health outcomes in MS.

scholarly journals A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

2004 ◽  
Vol 16 (1) ◽  
pp. 33-49 ◽  
Author(s):  
Claudia K. Y. Lai ◽  
Iris Chi ◽  
Jeanie Kayser-Jones
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Repeated Measures ◽  
Comparison Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nursing Home Residents ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

PHARMACEUTICAL CARE OF ADOLESCENTS WITH DIABETES MELLITUS TYPE 1: THE DIADEMA STUDY, A RANDOMIZED CONTROLLED TRIAL

2015 ◽  
Vol 101 (1) ◽  
pp. e1.67-e1
Author(s):  
Emina Obarčanin ◽  
Manfred Krueger ◽  
Petra Mueller ◽  
Verena Nemitz ◽  
Holger Schwender ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Pharmaceutical Care ◽  
Intervention Group ◽  
Well Being ◽  
Diabetes Mellitus Type ◽  
Control Group ◽  
Randomized Controlled ◽  
Phone Calls ◽  
The Impact

BackgroundAdolescents with type 1 diabetes mellitus (T1DM) often show low adherence to complex insulin regimens, leading to poor glycemic control. The benefit of pharmaceutical care in adults with diabetes mellitus type 2 (T2DM) has been widely explored; however, evidence in adolescents with T1DM remains scarce.ObjectiveTo evaluate the impact of pharmaceutical care in adolescents with T1DM provided by a multidisciplinary team on multiple important clinical outcomes.SettingAt the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one pharmacist on-site in Sarajevo, Bosnia-Herzegovina.MethodsA randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care delivered by pharmacists plus supplementary phone calls for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. In addition, HbA1c was measured after 12 months.Main outcome measures The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c), the number of severe hypoglycemic events in both groups, and patient well-being in the intervention group.ResultsThe improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline −0.54 vs. +0.32%, p=0.0075), even after adjustment for country-specific variables (p=0.0078). However, the effect was more pronounced after only 3 months (−1.09 vs. +0.23%, p=0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. After 6 months, the well-being according to the WHO-5 index in the intervention group increased significantly from 52.8% to 63.3%. After 12 months the mean total HbA1c remained significantly reduced in the intervention compared to the control group (8.6% vs. 9.5%, p=0.0184).ConclusionThe improved outcomes seen in this study provide new evidence that pharmaceutical care adds value to the management of T1DM in adolescents. However, the optimal methods of achieving sustained long-term improvements in this specific patient population require further study.

scholarly journals Comparing The Effects of Self-Selected Music Versus Predetermined Music On Patient Anxiety Prior To Gynaecological Surgery: The MUANX Randomized Controlled Trial

2021 ◽  
Author(s):  
Danielle Reynaud ◽  
Nicolas Bouscaren ◽  
Victorine Lenclume ◽  
Malik Boukerrou
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Gynaecological Surgery ◽  
Patient Anxiety ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).Methods: The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 minutes of music one hour before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).Results: The mean age of the 171 evaluated patients was 41.5 years (SD=10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M=38.8, SD=11.9) and the intervention group (M=39.0, SD=13.1). After the music session, this score had significantly decreased in both the control group (M= -7.2, SD=9.0) and the intervention group (M=-5.5, SD=6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.Conclusion: Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.Trial registration The MUANX trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1

scholarly journals An assisted structured reflection on life events and life goals in advanced cancer patients: Outcomes of a randomized controlled trial (Life InSight Application (LISA) study)

2018 ◽  
Vol 33 (2) ◽  
pp. 221-231
Author(s):  
Renske Kruizinga ◽  
Michael Scherer-Rath ◽  
Johannes BAM Schilderman ◽  
Iris D Hartog ◽  
Jacoba PM Van Der Loos ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Life Goals ◽  
Control Group ◽  
Incurable Cancer ◽  
Randomized Controlled ◽  
Spiritual Well Being

Background: Diagnosis and treatment of incurable cancer as a life-changing experience evokes difficult existential questions. Aim: A structured reflection could improve patients’ quality of life and spiritual well-being. We developed an interview model on life events and ultimate life goals and performed a randomized controlled trial to evaluate the effect thereof on quality of life and spiritual well-being. Design: The intervention group had two consultations with a spiritual counselor. The control group received care as usual. EORTC QLQ-C15-PAL and the FACIT-sp were administered at baseline and 2 and 4 months after baseline. Linear mixed model analysis was performed to test between-group differences over time. Participants: Adult patients with incurable cancer and a life expectancy ⩾6 months were randomized in a 1:1 ratio to the intervention or control group. Results: A total of 153 patients from six different hospitals were included: 77 in the intervention group and 76 in the control group. Quality of life and spiritual well-being did not significantly change over time between groups. The experience of Meaning/Peace was found to significantly influence quality of life ( β = 0.52, adj. R2 = 0.26) and satisfaction with life ( β = 0.61, adj. R2 = 0.37). Conclusion: Although our newly developed interview model was well perceived by patients, we were not able to demonstrate a significant difference in quality of life and spiritual well-being between groups. Future interventions by spiritual counselors aimed at improving quality of life, and spiritual well-being should focus on the provision of sources of meaning and peace.

Improvements in Health-Related Quality of Life, Cardio-Metabolic Health, and Fitness in Postmenopausal Women After an Exercise Plus Health Promotion Intervention: A Randomized Controlled Trial

2017 ◽  
Vol 14 (5) ◽  
pp. 336-343 ◽  
Author(s):  
Mercedes Vélez-Toral ◽  
Débora Godoy-Izquierdo ◽  
Nicolás Mendoza Ladrón de Guevara ◽  
Carlos de Teresa Galván ◽  
Alberto Salamanca Ballesteros ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Metabolic Health ◽  
Metabolic Status ◽  
Control Group ◽  
Randomized Controlled ◽  
Health And Fitness ◽  
Mental Well Being

Background:This study explored multidimensional outcomes that were derived from the adherence to regular exercise among previously sedentary postmenopausal 45 to 64 years old women who engaged in a ~20-week exercise program.Methods:A randomized controlled trial with between-group (intervention and control women) and within-subject measures (baseline, postintervention, and 3-month and 12-month follow-ups) was conducted. HRQoL and several indicators of cardio-metabolic status and fitness were assessed.Results:After the intervention, the participants experienced a positive change in their short and long-term physical and mental health, with significant enhancements in several HRQoL dimensions, particularly mental well-being (23.3% of change) and menopause-related health and subdomains (17.0% of change) (P < .01). Improvements were maintained or continued (eg, mental well-being) overtime. These outcomes were accompanied by significant improvements in cardio-metabolic status and fitness, including weight, BMI, cardio-respiratory fitness and flexibility (up to 16.2% of change, P < .05). After the intervention, the intervention group exhibited better HRQoL than the control group at each of the measurement phases. Between-group differences were also observed for some indicators of cardiovascular health and flexibility.Conclusions:Our findings add evidence on the association of positive outcomes on HRQoL with improvements in cardio-metabolic health and fitness status after the adoption of an active lifestyle.

scholarly journals Effect of Positive Events Recording Based on Positive Psychology on Healthy Behaviours and Readmission Rate of Patients After PCI: A Study Protocol for a Prospective, Randomized Controlled Trial

2021 ◽  
Author(s):  
Yao yao Hu ◽  
Xin Jiang ◽  
Fang ying Mao ◽  
Jing Zhang ◽  
Lin Liu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Positive Psychology ◽  
Readmission Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Prevention Strategies ◽  
Positive Events ◽  
Randomized Controlled ◽  
New Ideas

Abstract Background: Unhealthy behaviours of coronary heart disease (CHD) patients are closely related to the occurrence of major heart events, which increases the readmission rate and brings heavy economic burden to families and society. Therefore, it is necessary for health care workers to take active preventive and therapeutic measures to keep or establish healthy behaviours of patients. Positive psychological intervention has been proved to be effective, but it has not been reported in the field of CHD in China. The purpose of this study is to explore the effects of positive events recording based on positive psychology on the healthy behaviours, readmission rate and anxiety of patients with CHD, in order to provide new ideas for the development of secondary prevention strategies for CHD.Methods: This is a prospective, single-center, randomized controlled trial (RCT). The subjects will be enrolled from the Department of Cardiology, the First Affiliated Hospital of Soochow University. There are 80 cases in total, according to the random number table, the subjects are randomly divided into the intervention group (n=40) and the control group (n=40). The patients in the intervention group will receive the intervention of recording positive events once a week for 3 months, while the patients in the control group receive conventional nursing, and each group will be followed up for 6 months. The primary outcomes will include healthy behaviours, readmission rate and anxiety, the secondary outcomes will include psychological capital, subjective well-being and corresponding clinical laboratory indicators. The protocol was approved by the Medical Ethics Committee of Soochow University (approval No. SUDA20200604H01) and is performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. All participants provide written informed consent.Discussion: This study will verify whether positive events recording based on positive psychology can make patients maintain healthy behaviours, reduce readmission rate and improve anxiety after PCI. Then, this study will provide new ideas and references for the development of secondary prevention strategies for patients with CHD. Trial registration: Chinese Clinical Trials Registry, 2000034538. Registered on 10 July 2020.

scholarly journals Awakening Compassion in Managers—a New Emotional Skills Intervention to Improve Managerial Compassion

2020 ◽  
Author(s):  
Miia Paakkanen ◽  
Frank Martela ◽  
Jari Hakanen ◽  
Lotta Uusitalo ◽  
Anne Pessi
Keyword(s):  
Leadership Behaviors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Organizational Research ◽  
Emotional Skills ◽  
Randomized Controlled ◽  
Post Test ◽  
The Impact

Abstract Compassion is in high demand within organizational research, with important implications for leadership, well-being, and productivity. However, thus far only meditation-based interventions have been implemented to increase compassion in organizations. Our aim was to explore whether compassion could be increased among managers through improving their emotional skills. We implemented a quasi-randomized controlled trial with pre-test and post-test design of a new emotional skills cultivation training among managers, measuring the treatment group (N = 68), the control group (N = 90), and their followers (N = 85 and N = 72). Compared to the control group, the managers exhibited significantly increased sense of emotional skills, with some evidence for an improved sense of compassion. We also found that emotional skills mediated the impact of participating in the intervention group and compassion. Additionally, servant leadership behaviors in the intervention group improved following the intervention. These results demonstrate that instead of being something innate, compassion is a skill that can be increased through training emotional skills, with observable benefits for the organization.

scholarly journals Effect of Cinnamon on Inflammatory Factors, Pain and Anthropometric Indices in Progressive-relapsing Multiple Sclerosis Patients: A Randomized Controlled Trial

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Elham Delaviz ◽  
Moosa Salehi ◽  
Afsane Ahmadi ◽  
Mohammad Fararooei ◽  
Mahdis Vakili ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Inflammatory Factors ◽  
Control Group ◽  
Pain Level ◽  
Anthropometric Indices ◽  
Randomized Controlled ◽  
Before And After ◽  
Hs Crp

Background: Multiple sclerosis (MS) is the most disabling neurological disease and has been studied for decades, but there are still many unproven treatments. Cinnamon (Cinnamomum zeylanicum) is a well-known herb and has many therapeutic applications. Objectives: This study aimed to evaluate the effect of cinnamon on inflammatory factors, pain, and anthropometric indices in patients with progressive-relapsing MS. Methods: In this randomized controlled trial, 60 patients suffering from progressive-relapsing MS were randomly recruited from Shiraz MS Center. Four capsules of cinnamon were taken every day for eight weeks by each participant in the intervention group (500 mg in each capsule) and four capsules of wheat flour by the control group (500 mg in each capsule). A 3-day 24-h food recall and physical activity questionnaire was filled out by interviewing before and after the intervention. Pain level was evaluated by using a Visual Analog scale (VAS). Interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were measured in blood samples before and after the intervention. Participants underwent anthropometric measurements, including body weight, height, and waist and hip circumference. Results: Thirty-six (87.80%) participants were female, and twenty-six patients were married (63.41%). IL-6 and hs-CRP levels decreased significantly in the intervention group compared to the control group (P < 0.05). According to the VAS results, the pain level also decreased significantly (P = 0.003) in the intervention group in comparison to the control group. Conclusions: Multiple sclerosis is a debilitating inflammatory disease, and cinnamon may help improve inflammatory markers and pain in MS patients.

scholarly journals The effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia: a parallel randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Maryam Behrouian ◽  
Tahereh Ramezani ◽  
Mahlagha Dehghan ◽  
Abdoreza Sabahi ◽  
Batool Ebrahimnejad Zarandi
Keyword(s):  
Randomized Controlled Trial ◽  
Emotion Regulation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Psychological Traits ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Abstract Background Schizophrenia is the most severe mental chronic disabling disease that the majority of the patients need constant care in a variety of aspects. Regarding the role of family caregivers in taking care of these patients, caregivers need to be resilient, in addition to other psychological traits, to adapt to the circumstance. This study aimed to investigate the effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia in southeastern Iran. Methods The study was a parallel randomized controlled trial. Seventy caregivers of patients with schizophrenia were selected by convenience sampling method and randomly assigned to an emotion regulation training group and a control group. The intervention group received eight 90-min training sessions (one session weekly) about emotion regulation. The participants completed the Conner–Davidson resilience scale before and one month after the intervention. Results The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found between the two groups (p < 0.001). At the beginning of the study, the mean score of the resilience was 59.94 in the control group and 51.97 in the intervention group. However, the mean score of the resilience in the control group was 61.28 after the intervention, which was not significant, but it was 69.08 in the intervention group, which was significant. A significant difference was observed between two groups in the mean scores (p = 0.01). Conclusions According to the results of this study, cognitive and metacognitive skills of emotion regulation can be suggested as one of the methods for increasing the psychological well-being of schizophrenia patients’ caregivers. The increase of mental well-being and resilience of caregivers can help them better manage a patient with schizophrenia. Trial registration IRCT registration number: IRCT2017061733997N2, Registration date: 2017-08-16, 1396/05/25, Registration timing: prospective, https://en.irct.ir/trial/26116

scholarly journals BRAIN FITNESS INTERVENTION ON KNOWLEDGE AND WORRIES ABOUT ALZHEIMER’S: A RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S1-S1
Author(s):  
Kaipeng Wang ◽  
Fei Sun ◽  
Qiuling An ◽  
Yanfei Han ◽  
Yi Zhou
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Tai Chi ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Brain Fitness

Abstract As one of the world’s fastest aging countries, China’s growing prevalence of Alzheimer’s and related dementias (ADRD) poses concerns among older adults. Lack of knowledge about ADRD and excessive worries about ADRD can cause cumulative stress and threaten physical and psychological well-being of older adults. We conducted a randomized controlled trial to examine the effectiveness of a Brain Fitness Intervention (BFI) on the knowledge and worries about Alzheimer’s at three senior residential care facilities in China. Ninety older adults aged 60 and above underwent randomization. Fifty participants in the intervention group received eight weekly BFI sessions, including Tai Chi exercise, experiential learning, and group discussions. The primary outcomes were the changes from baseline to Week 8 in the scores on the ADRD knowledge scale (ranging 5–50) and worry scale (ranging 5–45). Twenty-seven participants withdrew from the study. Intent-to-treat analysis showed that the estimated mean change in knowledge on ADRD was 4.26 in the treatment group and -1.52 in the control group (p &lt; 0.001). The estimated mean change in worries about ADRD was -10.25 in the treatment group and -2.9 in the control group (p &lt; 0.001). Results remained robust in sensitivity analysis adjusting for study sites and baseline characteristics. Heterogeneity analysis showed that the treatment effect became stronger with the increase of age. Findings support the effectiveness of BFI in increasing ADRD knowledge and reducing worries among Chinese older adults. Future trials with larger sample sizes will be needed for more conclusive results.

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