Meditation and mindfulness reduce perceived stress in women with recurrent pregnancy loss: A randomized controlled trial with a 12-month follow-up

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

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Stressor-Oriented MUlticomponent Intervention and the WeLl-Being of Patients with Alzheimer’s Disease: A Randomized Controlled Trial (SOUL-P)

Journal of Alzheimer s Disease ◽

10.3233/jad-200652 ◽

2021 ◽

Vol 79 (1) ◽

pp. 141-152

Author(s):

Bing Yang ◽

Siyuan Yang ◽

Yunmei Zhang ◽

Wentao Liu ◽

Yao Gan ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Randomized Controlled Trial ◽

Perceived Stress ◽

Family Conflict ◽

Multidisciplinary Team ◽

Controlled Trial ◽

Well Being ◽

Randomized Controlled

Background: Patients with Alzheimer’s disease (AD) experience various stressors that negatively impact well-being. Most studies have, however, small effect size and are limited by the experiences of severe patients. Therefore, we conducted a single-blind, randomized controlled trial, which has included patients at different stages. Objective: The stressor-oriented multicomponent program was designed as an intervention for AD patients to enhance well-being. Methods: Patients were randomly assigned to control or SOUL-P conditions according to disease severity. The SOUL-P group received 15 intensive sessions over 6 months and 6 maintenance sessions over a 6-month follow-up by a multidisciplinary team comprising psychologists, occupational therapists, and community nurses. The control group received a similar number of sessions by community nurses. Stress-related outcomes (primary stressors and well-being outcomes) were obtained from in-person baseline and follow-up interviews conducted at 6- and 12-months post-baseline. A treatment compliance survey was conducted at the intervention endpoint for patients. Results: Of the 863 patients screened, 218 (25.3%) were eligible. At 6 months, compared to controls, SOUL-P patients had improved quality of life (QoL) (p < 0.001; Cohen d = 0.56), depression (p = 0.020; Cohen d = –0.33), neurobehavioral symptoms (p = 0.034; Cohen d = –0.30), perceived stress (p = 0.030; Cohen d = –0.31), and family conflict (p = 0.026; Cohen d = –0.32). QoL, depression, perceived stress, and family conflict were still significantly different at 12 months. Most patients were satisfied with SOUL-P, while caregivers in the SOUL-P group reported overloading tasks. Conclusion: SOUL-P may reduce perceived stress and improve psychological outcomes in AD patients. Stressor-based interventions, patient-oriented goals, and a multidisciplinary team are essential features for a successful SOUL-P.

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Resilience, Insight, Self-Compassion, and Empowerment (RISE): A Randomized Controlled Trial of a Psychoeducational Group Program for Nurses

Journal of the American Psychiatric Nurses Association ◽

10.1177/10783903211033338 ◽

2021 ◽

pp. 107839032110333

Author(s):

Amanda T. Sawyer ◽

Amanda K. Bailey ◽

Jeanette F. Green ◽

Jingwei Sun ◽

Patricia Stearnes Robinson

Keyword(s):

Randomized Controlled Trial ◽

Perceived Stress ◽

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Psychoeducational Group ◽

Randomized Controlled ◽

Self Compassion ◽

Mind Set

Background: Nurses tend to be vulnerable to burnout and compassion fatigue due to constant workplace stressors. There is a need to provide advocacy, education, programming, and resources in the areas of positive coping and self-care to reduce burnout symptoms and promote well-being. RISE is an 8-week psychoeducational group intervention for nurses with four themes: resilience, insight, self-compassion, and empowerment. Objectives: This randomized controlled trial examined the effects of RISE on mental well-being. Methods: The sample included 75 registered nurses who work in a hospital-based setting. Outcomes included resilience, insight, self-compassion, empowerment, stress mind-set, perceived stress, and burnout. Independent-samples t tests were conducted to compare outcomes between intervention and wait-list control groups at baseline and 1-month follow-up, as well as at 3-month follow-up. Supplemental analyses included paired-samples t tests and linear mixed models to compare the outcomes of the intervention group participants at baseline to 1-month follow-up, as well as at 3-month and 6-month follow-ups. Results: Participants in the intervention group showed improved levels of insight (i.e., engagement in self-reflection), perceived stress, and burnout (i.e., emotional exhaustion) when compared with the control group and improved levels of resilience, self-compassion, stress mind-set, and perceived stress when compared with their baseline. Conclusions: This study informs how RISE affects nurse well-being and may be an effective intervention for reducing burnout and stress. This type of whole-person intervention can support nurses to improve their well-being and ability to cope amid the complex interplay of factors at the individual, unit, and organizational levels.

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Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-020-04772-7 ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Luisa Weiner ◽

Fabrice Berna ◽

Nathalie Nourry ◽

François Severac ◽

Pierre Vidailhet ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Perceived Stress ◽

Healthcare Workers ◽

Behavioral Therapy ◽

Controlled Trial ◽

Healthcare Systems ◽

Randomized Controlled

Abstract Background The acknowledgment of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders, and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the ‘My Health too’ CBT program—a program we have developed for healthcare workers facing the pandemic—on immediate perceived stress and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy). Methods Powered for superiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels > 16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores at 8 weeks. Secondary outcomes include depression, insomnia, and PTSD symptoms; self-reported resilience and rumination; and credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks), and at 3-month and 6-month follow-up. Discussion This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers’ mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis. Trial registration ClinicalTrials.gov NCT04362358, registered on April 24, 2020.

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Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: The REduction of STress (REST) study protocol for a randomized controlled trial

10.21203/rs.3.rs-37423/v1 ◽

2020 ◽

Author(s):

Luisa Weiner ◽

Fabrice Berna ◽

Nathalie Nourry ◽

François Severac ◽

Pierre Vidailhet ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Cognitive Behavioral Therapy ◽

Perceived Stress ◽

Healthcare Workers ◽

Behavioral Therapy ◽

Controlled Trial ◽

Healthcare Systems ◽

Randomized Controlled

Abstract Background: The acknowledgement of the mental health toll of the COVID-19 epidemic in healthcare workers has increased considerably as the disease evolved into a pandemic status. Indeed, high prevalence rates of depression, sleep disorders and post-traumatic stress disorder (PTSD) have been reported in Chinese healthcare workers during the epidemic peak. Symptoms of psychological distress are expected to be long-lasting and have a systemic impact on healthcare systems, warranting the need for evidence-based psychological treatments aiming at relieving immediate stress and preventing the onset of psychological disorders in this population. In the current COVID-19 context, internet-based interventions have the potential to circumvent the pitfalls of face-to-face formats, and provide the flexibility required to facilitate accessibility to healthcare workers. Online cognitive behavioral therapy (CBT) in particular has proved to be effective in treating and preventing a number of stress-related disorders in populations other than healthcare workers. The aim of our randomized controlled trial study protocol is to evaluate the efficacy of the ‘My Health too’ CBT program – a program we have developed for healthcare workers facing the pandemic -- on immediate perceived stress, and on the emergence of psychiatric disorders at 3- and 6-month follow-up compared to an active control group (i.e., bibliotherapy). Methods: Powered for non-inferiority testing, this six-site open trial involves the random assignment of 120 healthcare workers with stress levels >16 on the Perceived Stress Scale (PSS-10) to either the 7-session online CBT program or bibliotherapy. The primary outcome is the decrease of PSS-10 scores. Secondary outcomes include depression, insomnia, and PTSD symptoms, self-reported resilience and rumination, as well as credibility and satisfaction. Assessments are scheduled at pretreatment, mid-treatment (at 4 weeks), end of active treatment (at 8 weeks) and at 3-month and 6-month follow-up. Discussion: This is the first study assessing the efficacy and the acceptability of a brief online CBT program specifically developed for healthcare workers. Given the potential short- and long-term consequences of the COVID-19 pandemic on healthcare workers’ mental health, but also on healthcare systems, our findings can significantly impact clinical practice and management of the ongoing, and probably long-lasting, health crisis. Trial registration: NCT04362358, registered April 24, 2020.

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Stress- and smoke free pregnancy study protocol: a randomized controlled trial of a personalized eHealth intervention including heart rate variability-biofeedback to support pregnant women quit smoking via stress reduction

BMC Public Health ◽

10.1186/s12889-021-10910-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Willeke van Dijk ◽

Mirjam Oosterman ◽

Imke Jansen ◽

Wieke de Vente ◽

Anja Huizink

Keyword(s):

Heart Rate ◽

Randomized Controlled Trial ◽

Smoking Cessation ◽

Perceived Stress ◽

Stress Reduction ◽

Controlled Trial ◽

Heart Rate Variability Biofeedback ◽

Randomized Controlled ◽

Ehealth Intervention

Abstract Background Maternal smoking and stress during pregnancy are associated with adverse health effects for women themselves and are risk factors for adverse developmental outcomes of the unborn child. Smoking and stress seem to be intertwined in various ways. First, the majority of smoking pregnant women is of lower socio-economic status, which is associated with higher levels of perceived stress. Second, smoking women often report to smoke because they feel stressed. Third, quitting smoking often increases perceived stress levels initially. Therefore, effective interventions are needed to support women with smoking cessation by reducing stress. The aim of this study is to test the effectiveness of an eHealth intervention on stress reduction and smoking cessation. Methods/design The Stress- and Smoke Free Start of Life (SSFSL) study is a randomized controlled trial (RCT) comparing a personalized eHealth intervention with a control condition. Inclusion criteria for the women are: (1) > 18 years of age, (2) < 28 weeks pregnant at recruitment, (3) currently smoking. Consenting participants will be randomly assigned to the intervention or control group. Participants allocated to the intervention group will receive an 8-week intervention delivered on their smartphone. The application includes psycho-education on pregnancy, stress, and smoking (cessation); stress-management training consisting of Heart Rate Variability-biofeedback; and a personalized stop-smoking-plan. Participants in the control condition will be invited to visit a webpage with information on pregnancy, stress, and smoking (cessation). Study outcomes will be collected via online questionnaires, at four timepoints: pre-intervention (baseline; t0), post-intervention (8 weeks + 1 day after t0; t1), follow up at two weeks after birth (t2), and follow up at three months after birth (t3). The primary outcome measure is self-reported smoking cessation. Secondary outcomes include daily self-reported number of cigarettes smoked, perceived stress, pregnancy experience, birth outcomes, and negative affectivity scores of the baby. Moreover, the mediating effect of stress reduction on smoking cessation will be examined, and possible moderators will be tested. Discussion If the eHealth intervention is effective in smoking cessation among pregnant smoking women, it can be implemented as a tool into the health care in the Netherlands. Trial registration Netherlands Trial Register, ID: NL8156. Registered on 11 November 2019.

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