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Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial.

ABSTRACT: INTRODUCTION:Recent studies have revealed a high prevalence of depression, anxiety and stress symptoms among university students, highlighting an urgent need for preventative measures at low cost to better support often overwhelmed support services. OBJECTIVE:Here we propose a protocol for assessing the feasibility of a randomised controlled trial (RCT) for an online transdiagnostic psychoeducational intervention called 'A Bite of ACT' compared with a waitlist control. METHODS AND ANALYSIS:This is an RCT with crossover design involving baseline assessments and two follow-up periods. The primary outcome measure will be the Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) for measuring the feasibility of the trial design and methods. Secondary outcomes include measures of well-being, social connectedness, quality of life (EuroQol Five Dimensions), depression, anxiety and stress (Depression Anxiety Stress Scales-21), as well as the process measures: psychological flexibility (Acceptance and Action Questionnaire-Second Version and the Mindful Attention Awareness Scale) and heart rate variability. Analysis will involve calculating descriptive statistics, examining trial feasibility outcomes through ACCEPT, and determining effect size measures to determine the sample size needed in a future trial (if indicated). Qualitative interviews and preliminary health economics analysis will provide additional insights into the feasibility of the intervention and trial methods. ETHICS AND DISSEMINATION:This study has been approved by the Department of Psychology Research Ethics Committee in the College of Human and Health Sciences at Swansea University. Dissemination will involve publication in international peer-reviewed journals, presentation of findings at relevant local, national and international conferences, and promotion of study outcomes using social media and other channels for disseminating findings to the wider community. TRIAL REGISTRATION NUMBER:NCT03810131; Pre-results.

SUBMITTER: Edwards DJ

PROVIDER: S-EPMC6661604 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial.

Edwards Darren J DJ Rainey Elinor E Boukouvala Vasiliki V Wells Yasmin Y Bennett Paul P Tree Jeremy J Kemp Andrew H AH

BMJ open 20190716 7

<h4>Introduction</h4>Recent studies have revealed a high prevalence of depression, anxiety and stress symptoms among university students, highlighting an urgent need for preventative measures at low cost to better support often overwhelmed support services.<h4>Objective</h4>Here we propose a protocol for assessing the feasibility of a randomised controlled trial (RCT) for an online transdiagnostic psychoeducational intervention called 'A Bite of ACT' compared with a waitlist control.<h4>Methods ...[more]

PMID: 31315873

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Project description:BackgroundThe workload associated with caring for a person with dementia (PwD) could negatively affect informal caregivers' physical and mental health. According to the recent literature, there is a need for studies testing the implementation of affordable and accessible interventions for improving caregivers' well-being.AimsThis study aimed to explore the feasibility and effectiveness of an 8 week eHealth psychoeducation intervention held during the COVID-19 pandemic in Italy in reducing the psychological burden and neuroendocrine markers of stress in caregivers of PwD.MethodsForty-one informal caregivers of PwD completed the eHealth psychoeducation intervention. Self-reported (i.e., caregiver burden, anxiety symptoms, depressive symptoms, and caregiver self-efficacy) and cortisol measurements were collected before and after the intervention.ResultsFollowing the intervention, the caregivers' self-efficacy regarding the ability to respond to disruptive behaviours improved (t = - 2.817, p = 0.007), anxiety and burden levels decreased (state anxiety: t = 3.170, p = 0.003; trait anxiety: t = 2.327, p = 0.025; caregiver burden: t = 2.290, p = 0.027), while depressive symptoms and cortisol levels did not change significantly. Correlation analyses showed that the increase in self-efficacy was positively associated with the improvement of caregiver burden from pre- to post-intervention (r = 0.386, p = 0.014). The intervention had a low rate of dropout (n = 1, due to the patient's death) and high levels of appreciation.DiscussionThe positive evidence and participation rate support the feasibility and effectiveness of the proposed eHealth psychoeducational intervention to meet the need for knowledge of disease management and possibly reduce detrimental effects on caregivers' psychological well-being.ConclusionFurther placebo-controlled trials are needed to test the generalizability and specificity of our results.

Project description:OBJECTIVE:To assess feasibility and pilot a supported psychoeducational tool to improve parent and child mental health following discharge from a paediatric intensive care unit (PICU), in preparation for a large randomised controlled trial (RCT). DESIGN:Feasibility assessment and single-centre, parallel group, pilot RCT. A concealed computer generated list was used to randomise participants, with an allocation of 2:1 in favour of the intervention. SETTING:A PICU in an acute care hospital in London, UK. PARTICIPANTS:31 parents of children aged 4-16 years-old admitted to PICU. INTERVENTION:Parents received a psychoeducational tool supported by a telephone call. The psychoeducational tool outlined the possible psychological reactions in children and parents alongside management advice. The telephone call addressed each family's postdischarge experience, reinforced the psychoeducational material and encouraged parents to put into practice the advice given. MAIN OUTCOME MEASURES:The primary outcome was the number of feasibility criteria successfully met (linked to the intervention and the study design). Secondary outcomes were questionnaire data collected at 3-6-month follow-up assessing mental health in parents and children. RESULTS:31 parents were randomised (intervention n=22; treatment as usual, TAU n=9). 23 parents were included in the analysis of secondary outcomes (intervention n=17; TAU n=6). 3 (of 6) intervention and 1 (of 6) study design feasibility criteria were fully met. All unmet criteria could be addressed with minor or significant modifications to the protocol. At follow-up there was a tendency for parents who received the intervention to report lower post-traumatic stress symptoms in themselves and fewer emotional and behavioural difficulties in their children than TAU parents. This needs to be explored in a fully powered trial. CONCLUSIONS:This feasibility and pilot RCT provided valuable information on the intervention and trial design for a full RCT. TRIALS REGISTRATION NUMBER:NCT01737021; Results.

Project description:BackgroundCollege environments promote high-volume or binge alcohol consumption among youth, which may be especially harmful to those with type 1 diabetes (T1D). Little is known about the acceptability and effectiveness of interventions targeting reduced alcohol use by college students with T1D, and it is unclear whether intervention framing (specifically, the narrator of intervention messages) matters with respect to affecting behavior change. Interventions promoted by peer educators may be highly relatable and socially persuasive, whereas those delivered by clinical providers may be highly credible and motivating.ObjectiveThe aim of this study is to determine the acceptability and impacts of an alcohol use psychoeducational intervention delivered asynchronously through web-based channels to college students with T1D. The secondary aim is to compare the impacts of two competing versions of the intervention that differed by narrator (peer vs clinician).MethodsWe recruited 138 college students (aged 17-25 years) with T1D through web-based channels and delivered a brief intervention to participants randomly assigned to 1 of 2 versions that differed only with respect to the audiovisually recorded narrator. We assessed the impacts of the exposure to the intervention overall and by group, comparing the levels of alcohol- and diabetes-related knowledge, perceptions, and use among baseline, immediately after the intervention, and 2 weeks after intervention delivery.ResultsOf the 138 enrolled participants, 122 (88.4%) completed all follow-up assessments; the participants were predominantly women (98/122, 80.3%), were White non-Hispanic (102/122, 83.6%), and had consumed alcohol in the past year (101/122, 82.8%). Both arms saw significant postintervention gains in the knowledge of alcohol's impacts on diabetes-related factors, health-protecting attitudes toward drinking, and concerns about drinking. All participants reported significant decreases in binge drinking 2 weeks after the intervention (21.3%; odds ratio 0.48, 95% CI 0.31-0.75) compared with the 2 weeks before the intervention (43/122, 35.2%). Changes in binge drinking after the intervention were affected by changes in concerns about alcohol use and T1D. Those who viewed the provider narrator were significantly more likely to rate their narrator as knowledgeable and trustworthy; there were no other significant differences in intervention effects by the narrator.ConclusionsThe intervention model was highly acceptable and effective at reducing self-reported binge drinking at follow-up, offering the potential for broad dissemination and reach given the web-based format and contactless, on-demand content. Both intervention narrators increased knowledge, improved health-protecting attitudes, and increased concerns regarding alcohol use. The participants' perceptions of expertise and credibility differed by narrator.Trial registrationClinicalTrials.gov NCT02883829; https://clinicaltrials.gov/ct2/show/NCT02883829.International registered report identifier (irrid)RR2-10.1177/1932296819839503.

Project description:Background:E-mental health is an established mode of delivering treatment for common mental disorders in many high income countries. However, evidence of its effectiveness in lower income countries is lacking. This mixed methods study presents lessons learned and preliminary data on the feasibility of a minimally guided e-mental health intervention in Lebanon. The aim was to pilot test Step-by-Step, a WHO guided e-mental health intervention, and research methods prior to future, controlled testing. Methods:Participants were recruited using social media and advertisements in primary care clinics. Participants completed baseline and post-intervention questionnaires on depression symptoms (primary outcome, PHQ-8), anxiety symptoms, well-being, disability and self-perceived problem severity, and a client satisfaction questionnaire. In addition, seven completers, four drop-outs, 11 study staff, and four clinic managers were interviewed with responses thematically analyzed. Website analytics were used to understand participant behavior when using the website. Results:A total of 129 participants signed up via the Step-by-Step website. Seventy-four participants started session 1 after completing pre-test questionnaires and 26 completed both baseline and post-intervention data. Among those who completed post-assessments, depression symptoms improved (PHQ-8 scores (t=5.62, p < 0.001 two-tailed, df = 25). Wilcoxon signed ranks tests showed a significant difference between baseline and post-Step-by-Step scores on all secondary outcome measures. Client satisfaction data was positive. Interview responses suggested that the intervention could be made more appropriate for younger, single people, more motivating, and easier to use. Those who utilized the support element of the intervention were happy with their relationship with the non-specialist support person (e-helper), though some participants would have preferred specialist support. E-helpers would have liked more training on complex cases. Website analytics showed that many users dropped out before intervention start, and that some re-entered screening data having been excluded from the study. Conclusion:Step-by-Step skills and techniques, model of service integration, and its non-specialist support element are acceptable. Though the sample was small and non-controlled and drop-out was high, results suggest that it may be effective in reducing depression and anxiety symptoms and increasing well-being. Lessons learned will inform content revision, the development of an app version of Step-by-Step, and the research methodology of upcoming effectiveness studies.

Project description:BACKGROUND:eHealth interventions show stronger effects when informed by solid behavioral change theories; for example, self-regulation models supporting people in translating vague intentions to specific actions have shown to be effective in altering health behaviors. Although these theories inform developers about which behavioral change techniques should be included, they provide limited information about how these techniques can be engagingly implemented in Web-based interventions. Considering the high levels of attrition in eHealth, investigating users' experience about the implementation of behavior change techniques might be a fruitful avenue. OBJECTIVE:The objective of our study was to investigate how users experience the implementation of self-regulation techniques in a Web-based intervention targeting physical activity and sedentary behavior in the general population. METHODS:In this study, 20 adults from the general population used the intervention for 5 weeks. Users' website data were explored, and semistructured interviews with each of the users were performed. A directed content analysis was performed using NVivo Software. RESULTS:The techniques "providing feedback on performance," "action planning," and "prompting review of behavioral goals" were appreciated by users. However, the implementation of "barrier identification/problem solving" appeared to frustrate users; this was also reflected by the users' website data-many coping plans were of poor quality. Most users were well aware of the benefits of adopting a more active way of living and stated not to have learned novel information. However, they appreciated the provided information because it reminded them about the importance of having an active lifestyle. Furthermore, prompting users to self-monitor their behavioral change was not sufficiently stimulating to make users actually monitor their behavior. CONCLUSIONS:Iteratively involving potential end users offers guidance to optimally adapt the implementation of various behavior change techniques to the target population. We recommend creating short interventions with a straightforward layout that support users in creating and evaluating specific plans for action.

Project description:BACKGROUND:Mental distress is a major public health problem which includes anxiety, depression and somatic symptoms such as sleeping problems, fatigue and headache. University students are consistently reported to have higher levels of mental distress compared to the general population. Although university students with mental distress have significantly impaired cognitive functioning, learning disabilities and poor academic performance, the burden of this problem in Tanzania is unknown. This study aimed to determine prevalence and factors associated with mental distress among undergraduate students in northern Tanzania. METHODS:A cross-sectional study was conducted among undergraduate students at Kilimanjaro Christian Medical University College from April-July 2018. Simple random sampling technique using probability proportional to size was used to sample students from their respective classes. Mental distress was screened using the self-reporting questionnaire (SRQ-20). Data was analyzed using Stata version 15.1. Frequencies and percentages were used to summarize categorical variables while mean and standard deviation for numeric variables. Multivariable logistic regression was used to determine factors associated with mental distress adjusted for potential confounders. RESULTS:A total of 402 undergraduate students participated in this study, 14% screened positive for mental distress. Residing off-campus (OR?=?0.44, 95%CI 0.20-0.96) and perceived availability of social support (OR?=?0.22, 95%CI 0.11-0.45) reduced the odds of mental distress while students with family history of mental distress (OR?=?2.60, 95%CI 1.04-6.57) and those with decreased grades than anticipated (OR?=?3.61, 95%CI 1.91-6.83) had higher likelihood of mental distress. CONCLUSION:One in every ten students screened was positive for mental distress. Those who reported a family history of mental illness and lower grades than anticipated had higher response of mental distress. To relieve students from stress and frustrations related to studies and their lives in general, this study recommends awareness creation, counselling to help those with mental health issues, establishment of student drop-in centers for such services and promotion of social and recreational activities at the college.

Project description:IntroductionInformation and psychological needs have been reported as one of the greatest areas of unmet needs for patients with melanoma. To respond to these needs, we developed the Melanoma Care Intervention, a developed psychoeducational intervention for people at high risk of developing another melanoma comprising of a newly developed melanoma educational booklet and individually tailored telephone support sessions provided by trained psychologists. The purpose of this study was to investigate the acceptability and feasibility of the Melanoma Care Intervention.MethodsTwenty-four adults (14 men, 10 women, mean age: 58 years, SD: 12.2) at high risk of developing a subsequent primary melanoma were recruited and randomly assigned 1:1 to the intervention (a psychoeducational booklet, a Cancer Council booklet on melanoma and up to five telephone-based sessions with a psychologist) or usual care (Cancer Council booklet only). Acceptability, feasibility, fear of cancer recurrence and secondary psychosocial outcomes were assessed at baseline, 1 and 6?months.ResultsSatisfaction and perceived benefits were rated highly for all intervention components, particularly the telephone-based psychology sessions (mean satisfaction and benefits: both 9.27 out of 10, SD=2.41). The quality of information and support provided throughout the trial was rated as 'high' by the intervention group, with a mean score of 4.6 out of a possible 5 (SD=0.9) and 4.2 (SD=1.2) for the control group.ConclusionsThe intervention was feasible and acceptable for improving psychological adjustment. Timely access to effective, evidence-based, psychological care is a recognised need for people with melanoma. The intervention is designed to directly address this need in a way that is feasible in a clinical setting, acceptable to patients and health professionals.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry on 19/03/2013 (Registration Number: ACTRN12613000304730).

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Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial.

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Novel ACT-based eHealth psychoeducational intervention for students with mental distress: a study protocol for a mixed-methodology pilot trial.

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