Online meditation training for people with multiple sclerosis: A randomized controlled trial

Background: Multiple sclerosis (MS) has a relevant impact on quality of life (QOL) and is associated with increased risks of psychological morbidity. Mindfulness-based interventions (MBIs) are among the most studied interventions, although few well-conducted studies have tested them in this field. Furthermore, the participation in typical MBIs may be impaired by time and logistics. Objective: We aimed to test the efficacy of an online MBI to improve QOL, psychological well-being, sleep, and fatigue. Methods: We conducted a randomized controlled trial, in which 139 participants were randomly assigned to an MS-specific online mindfulness meditation intervention or to a psychoeducational (active control) group. Participants were assessed for QOL, depression, anxiety, sleep problems, and fatigue, at three different times: at recruitment, after 2 months, and after 6 months. Results: In comparison to the control group, the experimental subjects reported higher QOL and lower depression, anxiety, and sleep problems at the end of intervention. However, after 6 months these group differences were no longer significant. Conclusion: An online MBI could be an effective psychological treatment for the promotion of well-being in MS in short-term. However, the lack of lasting effects requires the development of new strategies to support long-term changes.

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Effects of self-conditioning techniques in promoting weight loss in patients with severe obesity: a randomized controlled trial protocol

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170304 ◽

2017 ◽

Vol 4 (1) ◽

pp. 20 ◽

Cited By ~ 1

Author(s):

Simona Bo ◽

Farnaz Rahimi ◽

Bice Properzi ◽

Giuseppe Regaldo ◽

Ilaria Goitre ◽

...

Keyword(s):

Weight Loss ◽

Standard Care ◽

Traditional Approach ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Rapid Induction ◽

Conditioning Approach

Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesityMethods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.

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Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

10.2196/preprints.34409 ◽

2021 ◽

Author(s):

Kathleen P. O'Hora ◽

Raquel A. Osorno ◽

Dena Sadeghi-Bahmani ◽

Mateo Lopez ◽

Allison Morehouse ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

The Impact ◽

Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291714002505 ◽

2014 ◽

Vol 45 (7) ◽

pp. 1401-1412 ◽

Cited By ~ 15

Author(s):

P. Otero ◽

F. Smit ◽

P. Cuijpers ◽

A. Torres ◽

V. Blanco ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Caregiver Burden ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Indicated Prevention ◽

Randomized Controlled ◽

Term Efficacy

BackgroundAlthough depression is a common problem among non-professional caregivers, only one trial has evaluated the efficacy of indicated prevention targeting this population and the long-term efficacy is unknown. The aim of this study was to evaluate the long-term efficacy of a brief intervention for the indicated prevention of depression in a sample of female caregivers.MethodA randomized controlled trial was conducted involving 173 participants (mean age 53.9 years) who were allocated to the intervention (n = 89) or the usual-care control group (n = 84). Blinded interviewers conducted assessments at 1, 3, 6 and 12 months of follow-up. The main outcome measure was the incidence of major depression and the secondary outcomes were compliance with treatment, depressive symptoms, emotional distress and caregiver burden.ResultsAt the 12-month follow-up, a lower incidence of depression as evaluated using the Structured Clinical Interview for Axis I Disorders of the DSM-IV was found in the intervention group compared with the control group (10.1%v.25.0%). The relative risk was 0.40 and statistically significant [χ2 = 6.68, degrees of freedom = 1,p = 0.010, 95% confidence interval (CI) 0.20–0.81], and the number needed to treat was 7 (95% CI 4–27). There was a significant delay in the onset of depression in the intervention group (p = 0.008). The good complier caregivers had a lower incidence of depression. The intervention effect on depressive symptoms, emotional distress and caregiver burden were maintained for 12 months.ConclusionsThis is the first study to demonstrate that a brief problem-solving intervention can prevent the onset of depression among non-professional caregivers over the longer term.

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

International Psychogeriatrics ◽

10.1017/s1041610204000055 ◽

2004 ◽

Vol 16 (1) ◽

pp. 33-49 ◽

Cited By ~ 80

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.

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A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/24264 ◽

2020 ◽

Vol 9 (12) ◽

pp. e24264

Author(s):

Hayley Wright ◽

Faith Martin ◽

Wendy Clyne ◽

Cain C T Clark ◽

Michael McGillion ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Data Collection ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Wait List ◽

Care Providers ◽

Randomized Controlled ◽

Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

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Effects of Hatha Yoga on caregivers of children and adolescents with cancer: a randomized controlled trial

Escola Anna Nery ◽

10.1590/2177-9465-ean-2019-0133 ◽

2020 ◽

Vol 24 (1) ◽

Author(s):

Marina Lima Daleprane Bernardi ◽

Maria Helena Costa Amorim ◽

Luciane Bresciane Salaroli ◽

Eliana Zandonade

Keyword(s):

Randomized Controlled Trial ◽

Children And Adolescents ◽

Controlled Trial ◽

Well Being ◽

Hatha Yoga ◽

Control Group ◽

Anxiety State ◽

Clinical Group ◽

Subjective Well Being ◽

Randomized Controlled

Abstract Objective: To assess the effects of a Hatha Yoga intervention on anxiety, subjective well-being, and attention levels of caregivers of children and adolescents with cancer, admitted to a public hospital in the city of Vitória, state of Espírito Santo, Brazil. Methods: A randomized controlled trial was performed. Thirty-six volunteers were allocated to clinical (participated in 4 to 6 Hatha Yoga practices) or control groups and answered the questionnaires State-Trait Anxiety Inventory, Subjective Well-Being Scale, and Mindfulness Attention Awareness Scale before and after the intervention period. Mann-Whitney and Wilcoxon nonparametric analyses were performed to compare the groups to each other and at different moments. Results: The individuals' moderate anxiety state decreased in the clinical (p = 0.001) and control (p = 0.014) groups so that while the control group continued to present moderate anxiety, the clinical group presented low anxiety after the intervention. Positive affects increased, and adverse effects decreased in the clinical group (p <0.05). There were no relevant changes in satisfaction with life and attention levels in the two groups (p> 0.05). Conclusion and implications for practice: Hatha Yoga is a useful tool for healthcare professionals and caregivers in short-term hospital care to reduce anxiety and improve subjective well-being.

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Effects of Virtual Reality Associated With Serious Games for Upper Limb Rehabilitation in Patients With Multiple Sclerosis. a Randomized Controlled Trial

10.21203/rs.3.rs-16509/v4 ◽

2020 ◽

Author(s):

Alicia Cuesta-Gómez ◽

Patricia Sanchez-Herrera Baeza ◽

Edwin Daniel Oña-Simbaña ◽

Alicia Martínez-Medina ◽

Carmen Ortiz-Comino ◽

...

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Serious Games ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Experimental Group

Abstract Background: Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance. Methods: A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of one month without receiving any treatment. Results : In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side. Conclusions: An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.

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Gratitude as Mood Mediates the Effects of a 6-Weeks Gratitude Intervention on Mental Well-Being: Post hoc Analysis of a Randomized Controlled Trial

Frontiers in Psychology ◽

10.3389/fpsyg.2021.799447 ◽

2022 ◽

Vol 12 ◽

Author(s):

Ernst Bohlmeijer ◽

Jannis Kraiss ◽

Marijke Schotanus-Dijkstra ◽

Peter ten Klooster

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Sensitivity Analyses ◽

Control Group ◽

Multiple Mediation ◽

Randomized Controlled ◽

Gratitude Intervention ◽

Mental Well Being ◽

Gratitude Interventions

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted.

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

International Journal of MS Care ◽

10.7224/1537-2073.2020-020 ◽

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.

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Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial

Multiple Sclerosis Journal ◽

10.1177/13524585211046898 ◽

2021 ◽

pp. 135245852110468

Author(s):

Michelle H Cameron ◽

Andrea Hildebrand ◽

Cinda L Hugos ◽

Grace I Judd ◽

Garnett McMillan ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Exercise Program ◽

Control Group ◽

Post Intervention ◽

Randomized Controlled ◽

Credible Intervals ◽

Falls In Older Adults ◽

The Impact

Background: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown. Objectives: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS. Methods: This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis. Results: The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8–2.0) and 1.4 falls/month in the control group (95% CI = 0.9–2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4–6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4–0.9); control 0.8 falls/month (95% CI = 0.5–1.1)). Conclusion: In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.

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