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2. Materials and Methods
PMC10252280
2.1. Design
RECRUITMENT
This study was a parallel randomized controlled trial with an allocation ratio of 1:1 that was conducted at a multicampus healthcare system headquartered in Florida. Participants were randomized into the intervention or waitlist control group by a computer-generated randomized number. The randomization list was saved b...
PMC10252280
2.2. Sample
Using the level of significance alpha = 0.05, power = 0.8, and preliminary data from the pilot study for the primary outcome measured by the Posttraumatic Growth Inventory (mean difference = 12; standard deviation = 17) [
PMC10252280
2.3. Intervention
MAY
The program consists of nine weekly 90 min group sessions that fuse education through didactic content, therapeutic process through facilitation, and skill development through experiential learning and practice [The program is grounded in a theoretical framework based on acceptance and commitment therapy (ACT) [To comp...
PMC10252280
2.4. Data Collection
The following nine validated instruments were used to measure study outcomes: Posttraumatic Growth Inventory (PTGI) [
PMC10252280
2.5. Data Analysis
Paired-samples t-tests were conducted to compare outcomes in each group between baseline and endpoint. Repeated-measures ANOVA tests were also conducted to compare outcomes longitudinally between the intervention group and waitlist control group at baseline, endpoint, one-month follow-up, and three-month follow-up. Dat...
PMC10252280
2.6. Ethical Considerations
The study was approved by the Institutional Review Board of AdventHealth (IRBNet #1839775) and registered on
PMC10252280
3.1. Post-Traumatic Growth
Over the four timepoints of baseline, endpoint, one-month follow-up, and three-month follow-up, there were significant differences between the intervention group and control group in mean scores on the PTGI (
PMC10252280
3.2. Professional Quality of Life
Among intervention group participants, there were significant improvements in the Compassion Satisfaction subdomain mean score of the ProQOL between baseline and endpoint (40.91 vs. 42.82, t = −3.07,
PMC10252280
3.3. Program Themes
PMC10252280
3.3.1. Resilience
There were no significant differences in the mean score on the BRS among the intervention group participants between baseline and endpoint (3.81 vs. 3.79).
PMC10252280
3.3.2. Insight
Among intervention group participants, the overall mean score on the SRIS was significantly higher at the endpoint than at baseline (89.88 vs. 93.85, t = −2.09,
PMC10252280
3.3.3. Self-Compassion
There were no significant differences in the mean score on the SCS-SF among the intervention group participants between baseline and endpoint (3.19 vs. 3.35). However, the mean score was significantly higher at one-month follow-up (3.19 vs. 3.42, t = −2.82,
PMC10252280
3.3.4. Empowerment
Among intervention group participants, the overall mean score on the PEI was significantly higher at the endpoint than at baseline (5.41 vs. 5.82, t = −2.86, Although the mean score in the Impact subdomain was not significantly higher at the endpoint, it was at the one-month follow-up (5.22 vs. 5.73, t = −2.91,
PMC10252280
3.4. Perceived Stress, Job Satisfaction, and Self-Efficacy
Between baseline and endpoint, there were no significant differences in the mean score on the PSS (16.62 vs. 15.38), BIAJS (4.13 vs. 4.20) or GSE (33.29 vs. 33.91) among the intervention group participants. However, participants scored significantly lower on the PSS at the one-month follow-up compared to baseline (16.6...
PMC10252280
4. Discussion
post-traumatic
STS
Considering unit-based nurse leaders’ scope of influence on patient outcomes, nurse job satisfaction, and organizational culture [This study provides evidence of the effectiveness of a psychoeducational group program designed to address the wellbeing of this essential but often overlooked population. After the program,...
PMC10252280
4.1. Post-Traumatic Growth
post-traumatic, adversity, trauma
The finding of higher post-traumatic growth aligns with the results of the pilot study, which was conducted during the COVID-19 Delta surge in Florida [Although there is limited literature about post-traumatic growth and related interventions among nurse leaders, studies examining this phenomenon among direct care nurs...
PMC10252280
4.2. Professional Quality of Life
traumatic stress
STS
As previously mentioned, professional quality of life encompasses compassion satisfaction, burnout, and STS. A study conducted before the COVID-19 pandemic found that nurse leaders have average scores in these three subdomains [The mean Compassion Satisfaction score increased between baseline (40.91), endpoint (42.82),...
PMC10252280
4.3. Program Themes
PMC10252280
4.3.1. Resilience
Resilience training programs to address occupational stress have shown small to moderate positive effects [Literature on the need for resilience in the healthcare workforce has primarily focused on individual resilience, that is, the onus is on the individual to withstand and recover from workplace stress [
PMC10252280
4.3.2. Insight
The results show a significant improvement in self-reflection and insight among intervention participants at the endpoint, one-month, and three-month timepoints. Insight is foundational in any therapeutic or personal growth work and is positively associated with wellbeing and satisfaction with life and negatively assoc...
PMC10252280
4.3.3. Self-Compassion
painful emotions, adversity
While self-compassion scores did not show improvement at the endpoint, there were significant increases at one-month, three-month, and six-month follow-ups when compared to baseline. The lack of significant improvement immediately following the intervention but improved scores in follow-up timepoints might be explained...
PMC10252280
4.3.4. Empowerment
Empowerment among participants improved in all domains of the Psychological Empowerment Instrument–Meaning, Competence, Self-Determination, and Impact. The sustainability of the increased scores was stronger in the Meaning and Competence subdomains compared to the Self-Determination and Impact subdomains. Meaning and c...
PMC10252280
4.4. Perceived Stress, Job Satisfaction, and Self-Efficacy
Although a significant decrease in perceived stress was only seen at the one-month follow-up timepoint, the maintenance of these scores over the other timepoints provides support for these program themes as skill sets that can safeguard the effects of ongoing stressors. The instrument used to measure stress assesses pe...
PMC10252280
4.5. Limitations
In this study, there is the possibility of social desirability bias due to the self-reported nature of the data collected through validated instruments. Respondents may answer questions in a favorable way, such as overreporting a positive outcome such as compassion satisfaction and underreporting a negative outcome suc...
PMC10252280
4.6. Implications
With two pilot studies and two randomized controlled trials conducted on the original program for registered nurses and its adaptation for unit-based nurse leaders [Healthcare organizations can support unit-based nurse leaders by embedding evidence-based programs developed to reduce stress and burnout symptoms and prom...
PMC10252280
5. Conclusions
post-traumatic
SECONDARY, STS
This study adds to evidence that this psychoeducational group program can be an effective intervention for improving and protecting mental wellbeing, specifically among unit-based nurse leaders, which is a population for which there is a dearth of existing knowledge from cross-sectional and intervention studies. The fi...
PMC10252280
Author Contributions
Conceptualization, A.K.B. and A.T.S.; methodology, H.T.; formal analysis, H.T.; investigation, A.T.S.; resources, A.K.B.; writing—original draft preparation, A.T.S., A.K.B. and H.T.; writing—review and editing, A.T.S., A.K.B. and H.T.; visualization, A.T.S., A.K.B. and H.T.; project administration, A.T.S. All authors h...
PMC10252280
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of AdventHealth (IRBNet #1839775) on 13 December 2021.
PMC10252280
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC10252280
Data Availability Statement
The datasets generated and/or analyzed during the current study are not publicly available to protect the privacy of the participants but are available from the corresponding author upon reasonable request.
PMC10252280
Conflicts of Interest
The authors declare no conflict of interest.
PMC10252280
References
Post-Traumatic
Flowchart of Participants Withdrawal (WD) (i.e., scheduling conflict, more than three absences); Lost to Follow-up (LTF) (i.e., survey non-completion).Longitudinal Between-Groups Comparison of Post-Traumatic Growth.Demographic Characteristics of Participants.Within-Group Comparison (Paired Samples T-Test) at Baseline a...
PMC10252280
Abstract
PMC9830485
Aims
Despite the magnitude of alcohol use problems globally, treatment uptake remains low. This study sought to determine the proportion of people presenting to telephone-delivered alcohol treatment who are first-time help-seekers, and explored perceived barriers to help-seeking to understand the barriers this format of tre...
PMC9830485
Methods
Secondary analysis of baseline data from a randomized controlled trial of a telephone-delivered intervention for alcohol use problems. Latent class analysis (LCA) identified participant profiles according to self-reported barriers to alcohol treatment.
PMC9830485
Results
psychological distress, SD
DISORDER
Participants’ (344) mean age was 39.86 years (SD = 11.36, 18–73 years); 51.45% were male. Despite high alcohol problem severity (Alcohol Use Disorder Identification Test: mean = 21.54, SD = 6.30; 63.37% probable dependence), multiple barriers to accessing treatment were endorsed (mean = 5.64, SD = 2.41), and fewer than...
PMC9830485
Conclusion
The majority of people accessing this telephone-delivered intervention were new to treatment, yet had high alcohol problem severity. Two distinct profiles emerged, for which telephone interventions may overcome barriers to care and tailored approaches should be explored (e.g. increasing problem awareness, reducing psyc...
PMC9830485
INTRODUCTION
deaths
DISEASE
Alcohol consumption is a leading cause of preventable morbidity and mortality globally, resulting in 5.3% (3 million) of all deaths and 5.1% of all disease burden annually (Low rates of help-seeking for alcohol use problems are associated with multiple individual-level and structural barriers (Telephone-delivered inter...
PMC9830485
METHODS
PMC9830485
Study design
cognitive and behavioural intervention
SECONDARY
This was a secondary analysis of baseline data from a randomized controlled trial of a standalone telephone-delivered cognitive and behavioural intervention (Ready2Change; R2C) for individuals with alcohol use problems from the general population (Australian New Zealand Clinical Trials Registry,
PMC9830485
Participant recruitment and eligibility
MAY, RECRUITMENT, DISORDERS
The parent trial was conducted at Turning Point, a national addiction treatment and research centre based in Melbourne, Australia. Participants were recruited from across Australia between May 2018 and October 2019 via social media advertising, clinician referrals, and advertising in University and hospital newsletters...
PMC9830485
Data collection
Participants’ demographic (i.e. age, sex, culturally and linguistically diverse, Aboriginal and/or Torres Strait Islander descent, geographic area, education, employment status) and clinical information (i.e. alcohol problem severity, past-month drinking patterns, age of first/regular alcohol use, previous alcohol trea...
PMC9830485
Bias
Potential sources of bias were minimized in the following ways (
PMC9830485
Statistical analyses
Estimated resident population (ERP) data for Australia were used to calculate the rate of participation by geographic remoteness area (Latent class analysis (LCA) was performed to identify latent classes of individuals with similar response patterns on the NESARC’s set of 15 binary indicator variables addressing specif...
PMC9830485
RESULTS
Of 411 individuals screened for the parent trial, 344 were randomized and included in this study. Fifty-eight people were excluded from participating based on the study’s eligibility criteria, and nine eligible individuals were unable to be contacted for randomization. Individuals not eligible for participation reporte...
PMC9830485
Demographic and clinical characteristics
Demographic and clinical characteristics are presented in Demographic and clinical characteristics, and associations with treatment barrier class membershipChi-squared test for overall effect of education χ
PMC9830485
Previous alcohol treatment
Fewer than one-third of participants (101, 29.36%) had previously sought alcohol treatment. Among those who reported previous alcohol treatment, counselling (43, 12.50%), support and case management (e.g. GP advice, support and/or referral; 27, 7.85%) and pharmacotherapy (e.g. naltrexone, acamprosate, diazepam; 19, 5.5...
PMC9830485
Barriers to seeking treatment for alcohol problems
Participants endorsed multiple barriers to seeking treatment for alcohol problems (mean 5.64 barriers, SD = 2.41) and most frequently endorsed barriers belonging to attitudinal and readiness for change domains (Frequency of perceived barriers to seeking treatment for alcohol problems
PMC9830485
Latent class analysis model
Indices of model fit were compared across one-, two-, three-, four- and five-class models (Model fit indices for barriers to alcohol treatment of one- to five-class solutions
PMC9830485
Latent class profiles
Class one comprised 149 (43.3%) participants, and was operationalized as the ‘low problem recognition’ class. Class two comprised 195 (56.7%) participants, and was operationalized as the ‘complex barriers’ class (Weighted probability of endorsing treatment barriers by individuals presenting to telephone-delivered alcoh...
PMC9830485
Characteristics associated with treatment barrier class membership
REGRESSION
Bivariate analyses exploring associations between treatment barrier class membership and demographic and clinical characteristics (Multivariable logistic regression analysis for predictors of complex barrier class membership
PMC9830485
DISCUSSION
comorbidity, psychological distress
Of individuals with alcohol use problems from the general population presenting to a trial of telephone-delivered treatment, the majority (70.64%) were first-time help-seekers, despite two-thirds experiencing high levels of alcohol problem severity. This finding exceeds estimates from previous research that approximate...
PMC9830485
Strengths and limitations
LCA
The data utilized in this study was drawn from a treatment-seeking sample recruited to an alcohol treatment trial; data collection was rigorous and standardized, and the dataset was reviewed and cleaned prior to analysis. LCA is a rigorous model-based approach that provides several fit statistics to assess model fit, a...
PMC9830485
CONCLUSION
The majority of people presenting to telephone-delivered treatment for alcohol use problems were new to treatment, yet had high alcohol problem severity. More needs to be done to engage people with these easily accessible interventions earlier in their drinking trajectories. Participants had experienced multiple barrie...
PMC9830485
ACKNOWLEDGEMENTS
BROWN
We thank the counsellors who delivered the R2C telephone-delivered intervention to trial participants: Anna Bough, Jennifer Nation, Sally Brown and Adam Rubenis. We also thank Dr Jerry Lai and Deakin eResearch for their contribution to the set-up of the REDCap electronic data capture form for the R2C trial.
PMC9830485
FUNDING
The R2C trial was supported by a National Health and Medical Research Council (NHMRC) Project Grant (1125026; 2016). The funder was not involved in the conduct of the study or preparation of this manuscript.
PMC9830485
CRediT AUTHOR CONTRIBUTION STATEMENT
Jasmin Grigg: Conceptualization, methodology, formal analysis, writing—original draft, writing—review and editing. Victoria Manning: Funding acquisition, conceptualization, writing—review and editing. Alison Cheetham: Conceptualization, formal analysis, writing—original draft, writing—review and editing. George Youssef...
PMC9830485
CONFLICT OF INTEREST
D.L., V.M., K.H., A.B., P.S. and J.G. have received research grants from the NHMRC. D.L., V.M. and P.S. have received research funding from the Victorian Responsible Gambling Foundation. D.L., J.G. and V.M. have received research funding from VicHealth. D.L. is supported by a NHMRC Leadership Fellowship (1196892). A.B....
PMC9830485
DATA AVAILABILITY
Data are not shared as there is no participant permission or Ethics approval to do so, other than for related projects conducted by the research team.
PMC9830485
References
PMC9830485
Background
fatigue, cognitive impairment, anxiety, cancer, insomnia, depression
CANCER
Neuropsychiatric symptoms, comprising cognitive impairment, fatigue, insomnia, depression, and anxiety, are prevalent and may co-occur during and after chemotherapy treatment for cancer. Electroacupuncture (EA), which involves mild electrical stimulation with acupuncture, holds great potential in addressing the managem...
PMC10041509
Methods
cancer, claustrophobia, epilepsy
CANCER, METASTASES, BLEEDING DISORDERS, EPILEPSY
The EAST study is a randomized, sham-controlled, patient- and assessor-blinded clinical trial. Sixty-four cancer patients and survivors with complaints of one or more neuropsychiatric symptom(s) in the seven days prior to enrollment are recruited from the University of California Irvine (UCI) and Children’s Hospital of...
PMC10041509
Conclusion
cancer
CANCER
The EAST study can provide insight into the efficacy of EA, an integrative medicine modality, in the management of cancer symptom clusters in routine clinical practice.
PMC10041509
Keywords
PMC10041509
Background
fatigue, cancer, Acupuncture, psychological distress, insomnia, cognitive toxicity
CANCER, STERILE, OXIDATIVE STRESS
As of January 2019, it was estimated that there were 16.9 million cancer survivors in the United States, and this number was projected to increase by 31.4%, to 22.2 million by 2030 and to 26.1 million by 2040 [Acupuncture is an integrative medicine technique involving the insertion of single-use, sterile fine needles i...
PMC10041509
Methods
PMC10041509
Study design
This study is a randomized, sham-controlled, patient and assessor-blinded trial. The study protocol was approved by the institutional review board at the University of California, Irvine (UCI) and via reliance agreement with Children’s Hospital of Orange County (CHOC) and their institution’s respective institution revi...
PMC10041509
Study locations
The administration of EA will occur at the Susan Samueli Integrative Health Clinic at the UCI main campus. The MRI for the optional neuroimaging sub-study will be done at the FIBRE imaging center, located at the UCI main campus, where we will also consent patients for our study, when applicable. The study will be utili...
PMC10041509
Participants
Memory Impairments, UC
NEUROLOGICAL DISORDERS
Participants will be recruited from the UCI Medical Centers by advertisements, practitioner referrals, and the UC Health Data Warehouse’s Honest Brokers System. We will also utilize the Consent-2-Contact Registry from the UCI Institute for Memory Impairments and Neurological Disorders (UCI MIND) for patients who previo...
PMC10041509
Inclusion criteria
fatigue, anxiety, cancer, Memory impairment/attention deficit, insomnia, depression
CANCER
Diagnosed with cancer and have received anti-cancer treatment.≥ 16 years of age.Life expectancy ≥ 6 months.Complaints of two or more of the following symptoms: Memory impairment/attention deficit, fatigue, insomnia, depression, or anxiety over the past seven days.Able to provide informed consent to participate in the ...
PMC10041509
Exclusion criteria
Von Willebrand’s disease, psychiatric, hemophilia, Cancer
HEMOPHILIA, DISORDERS, BLEEDING DISORDER, EPILEPSY, CANCER
Cancer that has spread to one or more organs.Severe needle phobia.Severe psychiatric or medical disorders that would affect cognitive assessments.Known bleeding disorder (e.g., hemophilia, Von Willebrand’s disease, thrombocytopenia).Pacemaker or other electronic metal implants.Epilepsy.Received acupuncture therapy wit...
PMC10041509
Exclusion requirements for optional functional MRI scan
Non-removable metal orthodontic, claustrophobia
Severe claustrophobia.Non-removable metal orthodontic braces, metallic retainers, and oral wires.Metal fragments in the body.
PMC10041509
Randomization, allocation, and blinding
RECRUITMENT
After signing the informed consent, a total of 64 eligible participants will be stratified by recruitment sites [UCI (n = 34) or CHOC (n = 30)] and randomized in random blocks of four or six to receive either weekly vEA or weekly sEA. The practitioner who will perform the acupuncture treatment will then provide that in...
PMC10041509
Study procedures and time points
EVENT
Once a week for 10–12 weeks, participants will receive their respective treatments. The two-week buffer will be considered in the event of unexpected, missed treatment visits, such as illness or COVID-19 exposure. During the treatment period, there will be three time points at which participants will complete five ques...
PMC10041509
Study instruments
AcuBEST brand disposable, sterilized stainless-steel acupuncture needles (size 0.20 × 25 mm) with FDA 510k approval for administering acupuncture treatment.Study data will be collected and managed using REDCap electronic data capture tools hosted at UCI [OnCore™ clinical trial management system for storing patient inf...
PMC10041509
Interventions
PMC10041509
Sham EA group
Participants in the sEA group will receive acupuncture at non-disease related acupoints: Pianli (LI6) bilateral, Wenliu (LI7) bilateral, Fuyang (BL59) bilateral, Kunlun (BL60) bilateral, Sanyangluo (TE8) bilateral, Sidu (TE9) bilateral, and Daheng (SP15) bilateral with a superficial insertion and 2 Hz stimulation on ea...
PMC10041509
Sample size calculation
breast cancer, cognitive deterioration, Cancer
BREAST CANCER, CANCER
Based on our previous psychometric study of the Functional Assessment of Cancer Therapy – Cognitive Function (FACT-Cog) questionnaire, a decrease of 6.9–10.6 points (4.7–7.2% of the total score) in the FACT-Cog corresponds to the threshold for clinically significant cognitive deterioration in breast cancer patients [
PMC10041509
Outcomes
PMC10041509
Primary outcome measures
Self-perceived cognitive function
PMC10041509
Statistical analyses
ADVERSE EVENTS
Categorical variables (participants recruited, acupuncture sessions completed, participants completing all sessions, adverse events, participant responses to acceptability questionnaire) will be analyzed using descriptive statistics, presented as counts and percentages. All the descriptive statistics will be constructe...
PMC10041509
Data collection and management
CRF
RECRUITMENT, CRF
To warrant quality of the data, a well-trained assessor will be responsible for data collection and recording on the CRF on Microsoft Teams. Double entry of the data into REDCap will be implemented by clinical research coordinators. Regular monitoring of the recruitment, intervention, and assessment processes will be p...
PMC10041509
Study dissemination
In addition to disseminating our results to ClinicalTrials.gov and peer-reviewed journals, we intend to present results at relevant conventions and professional meetings.
PMC10041509
Discussion
sleep disturbance, cognitive impairment, fatigue, anxiety, cancer, anorexia/cachexia, insomnia, cancer-, depression
ADVERSE REACTIONS, CHRONIC PAIN, CANCER, COMPLICATIONS
Patients receiving chemotherapy face a group of unpleasant physical and psychological symptoms, such as fatigue, anxiety, depression, sleep disturbance, and cognitive impairment, often co-occurring as symptom clusters. These symptom clusters can have profoundly negative effects on patients’ quality of life.Numerous stu...
PMC10041509
Acknowledgements
Breast Cancer
BREAST CANCER
This material is based on work supported by The Regents of the University of California.We would like to thank the California Breast Cancer Research Program (CBCRP) 2022 - Innovative, Developmental, and Exploratory Award (IDEA) (Grant ID: B28IB5461) and the UCI CFCCC Anti-Cancer Challenge 2022 Pilot Project Award for p...
PMC10041509
Authors’ contributions
MH
AC, LX, SM, SL and DQN conceived the study, developed the methods, and participated in the study design. DQN, MH, MA, PC, NG, RP, CS, RT, KZ and LT are involved in the data collection process. All authors contributed to the drafting the final manuscript and approved the final manuscript.
PMC10041509
Funding
Breast Cancer
BREAST CANCER
Open Access funding enabled and organized by Projekt DEALFunding is provided by the California Breast Cancer Research Program (CBCRP), the UCI CFCCC Anti-Cancer Challenge 2022 Pilot Project.
PMC10041509
Data availability
The data collected and presented for our research can be found at ClinicalTrials.gov
PMC10041509
Declarations
PMC10041509
Trial status
Our trial has been approved by the UCI IRB (IRB #20216732). We foresee the study will be completed in the first quarter of 2024.
PMC10041509
Ethics approval and consent to participate
UC
All aspects of this study abide by the ethical guidelines put in place by the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. All participants involved in this study will be made aware of the potential risks and harms of this study and will be screened to ensure they are able to give consent. They ...
PMC10041509
Consent for publication
Not applicable.
PMC10041509
Competing interests
The authors declare that they have no competing interests.
PMC10041509
Abbreviations
ElectroacupunctureProportional Bone (skeletal) cunVerum ElectroacupunctureSham ElectroacupunctureRandomized Controlled Trial
PMC10041509
References
PMC10041509
2. Materials and Methods
PMC10744921
2.1. Study Design
This single-blind, randomized controlled trial was conducted from 29 October to 24 November 2019, and adhered to the ethical principles outlined in the Declaration of Helsinki. This study followed the reporting guidelines of the Consolidated Standards of Reporting Trials (CONSORT).
PMC10744921
2.2. Participants and Ethics
low back pain
RECRUITMENT
A total of 40 participants (20 males, 20 females) between the ages of 20 and 50 who visited the Shinbaro Orthopedic Clinic in Seoul, Republic of Korea for low back pain were enrolled in the study. Study participant recruitment began in October 2019, and all the data were obtained between October 2019 and November 2019....
PMC10744921
2.2.1. Inclusion Criteria
pain
Adults aged 20–50 years;Chronic back pain for more than 3 months;Lumbar lordotic angle (LLA) > 50°;Sacrohorizontal angle (SHA) > 40°.
PMC10744921