scholarly journals A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the ¡Alégrate! Randomized Controlled Trial

10.2196/17721 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e17721
Author(s):  
Rosalba Hernandez ◽  
Michael Cohn ◽  
Alison Hernandez ◽  
Martha Daviglus ◽  
Lizet Martinez ◽  
...  
Keyword(s):  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Spanish Language ◽  
Psychological Well Being ◽  
Web Based ◽  
Spanish Speaking ◽  
Randomized Controlled ◽  
Latino People ◽  
Positive Psychological Intervention

Background Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. Objective The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. Methods A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. Results Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. Conclusions Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. Trial Registration ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057 International Registered Report Identifier (IRRID) PRR1-10.2196/17721

scholarly journals A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the ¡Alégrate! Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Rosalba Hernandez ◽  
Michael Cohn ◽  
Alison Hernandez ◽  
Martha Daviglus ◽  
Lizet Martinez ◽  
...  
Keyword(s):  
Psychological Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Spanish Language ◽  
Psychological Well Being ◽  
Web Based ◽  
Spanish Speaking ◽  
Randomized Controlled ◽  
Latino People ◽  
Positive Psychological Intervention

BACKGROUND Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. OBJECTIVE The aim of this paper is to detail the protocol for the <i>¡Alégrate! (Be Happy!)</i> intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. METHODS A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language <i>¡Alégrate!</i> intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. RESULTS Activities of the <i>¡Alégrate!</i> intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. CONCLUSIONS Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. CLINICALTRIAL ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/17721

scholarly journals Evaluation of a Seven-Week Web-Based Happiness Training to Improve Psychological Well-Being, Reduce Stress, and Enhance Mindfulness and Flourishing: A Randomized Controlled Occupational Health Study

2013 ◽  
Vol 2013 ◽  
pp. 1-14 ◽  
Author(s):  
T. Feicht ◽  
M. Wittmann ◽  
G. Jose ◽  
A. Mock ◽  
E. von Hirschhausen ◽  
...  
Keyword(s):  
Occupational Health ◽  
Controlled Trial ◽  
Well Being ◽  
Self Report ◽  
Health Study ◽  
Psychological Well Being ◽  
Web Based ◽  
Attention Network ◽  
Randomized Controlled ◽  
The Impact

Background. As distress in society increases, including work environments, individual capacities to compete with stress have to be strengthened.Objective. We examined the impact of a web-based happiness training on psychological and physiological parameters, by self-report and objective means, in an occupational health setting.Methods. Randomized controlled trial with 147 employees. Participants were divided into intervention (happiness training) and control groups (waiting list). The intervention consisted of a seven-week online training. Questionnaires were administered before, after, and four weeks after training. The following scales were included: VAS (happiness and satisfaction), WHO-5 Well-being Index, Stress Warning Signals, Freiburg Mindfulness Inventory, Recovery Experience Questionnaire, and Flourishing Scale. Subgroup samples for saliva cortisol and alpha-amylase determinations were taken, indicating stress, and Attention Network Testing for effects on attention regulation.Results. Happiness (P=0.000;d=0.93), satisfaction (P=0.000;d=1.17), and quality of life (P=0.000;d=1.06) improved; perceived stress was reduced (P=0.003;d=0.64); mindfulness (P=0.006;d=0.62), flourishing (P=0.002;d=0.63), and recovery experience (P=0.030;d=0.42) also increased significantly. No significant differences in the Attention Network Tests and saliva results occurred (intergroup), except for one saliva value.Conclusions. The web-based training can be a useful tool for stabilizing health/psychological well-being and work/life balance.

scholarly journals The Influence of Connectedness to Nature on Psychological Well-Being: Evidence from the Randomized Controlled Trial Play&Grow

Challenges ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 12
Author(s):  
Tanja Sobko ◽  
Gavin T. L. Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Young Children ◽  
Psychological Health ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Path Model ◽  
Psychological Well Being ◽  
Connectedness To Nature ◽  
Randomized Controlled

Urbanized children today have fewer opportunities to interact with nature which may lead to a greater risk of mental health problems. The objective of this randomized controlled trial was to investigate which particular changes in connectedness to nature (CN) would improve psychological well-being (PW) in young children. Six hundred and thirty-nine preschoolers (52.0% boys, age 34.9 ± 9.5 months) participated in Play&Grow, an early environmental education intervention. Children’s CN and PW were evaluated by parents before and after the program with validated measures; the CNI-PPC (four factors) and the SDQ, Strength and Difficulties questionnaire (five factors), respectively. The effectiveness of the intervention on the primary outcomes (CN, PW) as well as the relationship between them was analyzed in a repeated measures path model with intervention status as a causal predictor. Specific CN factors consistently increased ProSocial behavior and reduced Hyperactivity and Emotional problems. In summary, this study showed that the previously reported impact shifted from the total CN score to the specific CN factors. The Play&Grow intervention positively increased children’s CN and improved some aspects of psychological well-being in children which is a preliminary evidence of developmental benefits of connecting young children with nature. Our results indicate promising direction of action for the improvement of families’ psychological health.

scholarly journals A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Andy Hau Yan Ho ◽  
Oindrila Dutta ◽  
Geraldine Tan-Ho ◽  
Toh Hsiang Benny Tan ◽  
Casuarine Xinyi Low ◽  
...  
Keyword(s):  
Palliative Care ◽  
Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Pediatric Palliative Care ◽  
Writing Intervention ◽  
Open Label ◽  
Web Based ◽  
Randomized Controlled ◽  
Life Threatening

BACKGROUND A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children. OBJECTIVE This study's aim was to provide an accessible platform, NeW-I—which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform—that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses. METHODS The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed. RESULTS Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing. CONCLUSIONS NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world. CLINICALTRIAL ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17561

Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 938-947 ◽  
Author(s):  
Mehdi Zemestani ◽  
Sharmin Mozaffari
Keyword(s):  
Emotion Regulation ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Psychological Flexibility ◽  
Well Being ◽  
Control Group ◽  
Psychological Well Being ◽  
Randomized Controlled ◽  
Acceptance And Commitment ◽  
Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

scholarly journals A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial

10.2196/17561 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e17561 ◽  
Author(s):  
Andy Hau Yan Ho ◽  
Oindrila Dutta ◽  
Geraldine Tan-Ho ◽  
Toh Hsiang Benny Tan ◽  
Xinyi Casuarine Low ◽  
...  
Keyword(s):  
Palliative Care ◽  
Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Pediatric Palliative Care ◽  
Writing Intervention ◽  
Open Label ◽  
Web Based ◽  
Randomized Controlled ◽  
Life Threatening

Background A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children. Objective This study's aim was to provide an accessible platform, NeW-I—which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform—that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses. Methods The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed. Results Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing. Conclusions NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world. Trial Registration ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382 International Registered Report Identifier (IRRID) DERR1-10.2196/17561

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