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)

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

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

JMIR Research Protocols ◽

10.2196/17561 ◽

2020 ◽

Vol 9 (7) ◽

pp. e17561 ◽

Cited By ~ 1

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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Correction: 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)

10.2196/preprints.22286 ◽

2020 ◽

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

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A Novel Narrative E-Writing Intervention (NeW-I) for Parents of Children with Chronic Life-Threatening Illnesses: Protocol for an Open-Label Randomized Controlled Trial

10.21203/rs.2.12263/v1 ◽

2019 ◽

Author(s):

Andy Hau Yan Ho ◽

Oindrila Dutta ◽

Geraldine Tan-Ho ◽

Toh Hsiang Benny Tan ◽

Casuarine Low Xinyi ◽

...

Keyword(s):

Palliative Care ◽

Support Services ◽

Controlled Trial ◽

Well Being ◽

Pediatric Palliative Care ◽

Writing Intervention ◽

Open Label ◽

Randomized Controlled ◽

Life Threatening Illness ◽

Life Threatening

Abstract Background: Conventionally, psycho-socio-emotional interventions for parents of children with chronic life-threatening illness begin post child loss. Evidence indicates pre-loss interventions addressing anticipatory grief can improve psycho-socio-emotional well-being and grief outcomes among family caregivers of dying patients, but no known intervention addresses the unique psycho-socio-emotional needs of Asian parents facing their child’s chronic life-threatening illness. Globally, palliative care strives to holistically support patients and their caregivers at the end-of-life, but inadequacies exist both globally and locally in pediatric palliative care and parental bereavement support services. Aim: A novel evidence-based Narrative e-Writing Intervention (NeW-I) is developed to address this gap. NeW-I is a strength-focused, meaning-oriented 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 facing their child’s chronic life-threatening illness. Methods: The design of NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of bereaved parents of children with chronic life-threatening illness. Together with four major local pediatric palliative care providers, NeW-I is implemented in Singapore as an open-label pilot randomized controlled trial with 66 parents and supplemented with a built-in accessibility and feasibility study. Discussion: NeW-I aspires to improve psycho-socio-emotional well-being of parents facing their child’s chronic life-threatening illness through a structured cyber-counseling platform, thereby enhancing holistic pediatric palliative care and parental bereavement support services. Findings from this pilot study can inform large-scale implementation and evaluation of NeW-I in Singapore and globally.

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A Novel Narrative E-Writing Intervention (NeW-I) for Parents of Children with Chronic Life-Threatening Illnesses: Protocol for an Open-Label Randomized Controlled Trial

10.21203/rs.2.12263/v2 ◽

2019 ◽

Author(s):

Andy Hau Yan Ho ◽

Oindrila Dutta ◽

Geraldine Tan-Ho ◽

Toh Hsiang Benny Tan ◽

Casuarine Low Xinyi ◽

...

Keyword(s):

Palliative Care ◽

Family Caregivers ◽

Controlled Trial ◽

Well Being ◽

Writing Intervention ◽

Open Label ◽

Randomized Controlled ◽

Life Threatening Illness ◽

Spiritual Well Being ◽

Life Threatening

Abstract Background: Conventionally, psycho-socio-spiritual interventions for parents of children with chronic life-threatening illness begin post child loss. Pre-loss interventions addressing anticipatory grief can improve holistic well-being and grief outcomes among family caregivers of dying patients. Globally, palliative care strives to holistically support patients and their caregivers at the end-of-life. However, inadequacies exist both globally and in Singapore in providing culturally sensitive psycho-socio-spiritual support to parents whose children need pediatric palliative services. Aim: A novel evidence-based Narrative e-Writing Intervention (NeW-I) is developed to address this gap. NeW-I is a strength-focused, meaning-oriented 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 facing their child’s chronic life-threatening illness. Methods: The design of NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of bereaved parents of children with chronic life-threatening illness. The online NeW-I platform and the relative anonymity it offers to participants is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with emotional expression even during times of loss and separation. Together with four local pediatric palliative care providers, NeW-I is implemented in Singapore as an open-label pilot randomized controlled trial with 72 parents. Potential effectiveness of NeW-I and accessibility and feasibility of implementing and delivering the intervention are assessed. Discussion: NeW-I aspires to improve psycho-socio-spiritual well-being of parents facing their child’s chronic life-threatening illness through a structured cyber-counseling platform, thereby enhancing holistic pediatric palliative care and parental bereavement support services. Findings from this pilot study will inform the development of a standardized NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world.

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

JMIR Research Protocols ◽

10.2196/22286 ◽

2020 ◽

Vol 9 (8) ◽

pp. e22286

Author(s):

Andy Hau Yan Ho ◽

Oindrila Dutta ◽

Geraldine Tan-Ho ◽

Toh Hsiang Benny Tan ◽

Xinyi Casuarine Low ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Writing Intervention ◽

Open Label ◽

Randomized Controlled ◽

Life Threatening

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A Novel Narrative E-Writing Intervention (NeW-I) for Parents of Children with Chronic Life-Threatening Illnesses: Protocol for an Open-Label Randomized Controlled Trial

10.21203/rs.2.12263/v3 ◽

2019 ◽

Author(s):

Andy Hau Yan Ho ◽

Oindrila Dutta ◽

Geraldine Tan-Ho ◽

Toh Hsiang Benny Tan ◽

Casuarine Low Xinyi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Writing Intervention ◽

Open Label ◽

Randomized Controlled ◽

Life Threatening

Abstract The authors have withdrawn this preprint from Research Square

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Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses: Study Protocol for a Randomized Controlled Trial (Preprint)

JMIR Research Protocols ◽

10.2196/23783 ◽

2020 ◽

Author(s):

Moustafa Ali Al-Shammari ◽

Amean Yasir ◽

Nuhad Aldoori ◽

Hussein Mohammad

Keyword(s):

Palliative Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Normalization Process Theory ◽

Process Theory ◽

Pediatric Palliative Care ◽

Training Intervention ◽

Web Based ◽

Randomized Controlled ◽

Normalization Process

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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

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/676953 ◽

2013 ◽

Vol 2013 ◽

pp. 1-14 ◽

Cited By ~ 43

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.

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A Web-Based Photo-Alteration Intervention to Promote Sleep: Randomized Controlled Trial (Preprint)

10.2196/preprints.12500 ◽

2018 ◽

Author(s):

Isabel Perucho ◽

Kamalakannan M Vijayakumar ◽

Sean N Talamas ◽

Michael Wei-Liang Chee ◽

David I Perrett ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Sleep Duration ◽

Controlled Trial ◽

Well Being ◽

Sleep Hygiene ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Information Group ◽

Function Of Sleep

BACKGROUND Receiving insufficient sleep has wide-ranging consequences for health and well-being. Although educational programs have been developed to promote sleep, these have had limited success in extending sleep duration. To address this gap, we developed a Web-based program emphasizing how physical appearances change with varying amounts of sleep. OBJECTIVE The aims of this study were to evaluate (1) whether participants can detect changes in appearances as a function of sleep and (2) whether this intervention can alter habitual sleep patterns. METHODS We conducted a 5-week, parallel-group, randomized controlled trial among 70 habitual short sleepers (healthy adults who reported having <7 hours of sleep routinely). Upon study enrollment, participants were randomly assigned (1:1) to receive either standard information or an appearance-based intervention. Both groups received educational materials about sleep, but those in the appearance group also viewed a website containing digitally edited photographs that showed how they would look with varying amounts of sleep. As the outcome variables, sleep duration was monitored objectively via actigraphy (at baseline and at postintervention weeks 1 and 4), and participants completed a measure of sleep hygiene (at baseline and at postintervention weeks 2, 4, and 5). For each outcome, we ran intention-to-treat analyses using linear mixed-effects models. RESULTS In total, 35 participants were assigned to each group. Validating the intervention, participants in the appearance group (1) were able to identify what they looked like at baseline and (2) judged that they would look more attractive with a longer sleep duration (<italic>t</italic>26=10.35, <italic>P</italic><.001). In turn, this translated to changes in sleep hygiene. Whereas participants in the appearance group showed improvements following the intervention (<italic>F</italic>1,107.99=9.05, <italic>P</italic>=.003), those in the information group did not (<italic>F</italic>1,84.7=0.19, <italic>P</italic>=.66). Finally, there was no significant effect of group nor interaction of group and time on actigraphy-measured sleep duration (smallest <italic>P</italic>=.26). CONCLUSIONS Our findings suggest that an appearance-based intervention, while not sufficient as a stand-alone, could have an adjunctive role in sleep promotion. CLINICALTRIAL ClinicalTrials.gov NCT02491138; https://clinicaltrials.gov/ct2/show/study/NCT02491138.

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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

JMIR Research Protocols ◽

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

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