scholarly journals A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial

10.2196/13666 ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. e13666 ◽  
Author(s):  
Jolie N Haun ◽  
Lisa M Ballistrea ◽  
Christine Melillo ◽  
Maisha Standifer ◽  
Kevin Kip ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Health Program ◽  
Controlled Trial ◽  
Web Based ◽  
Integrative Health ◽  
Randomized Controlled

scholarly journals A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a Mixed-Methods Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jolie N Haun ◽  
Lisa M Ballistrea ◽  
Christine Melillo ◽  
Maisha Standifer ◽  
Kevin Kip ◽  
...  
Keyword(s):  
Posttraumatic Stress Disorder ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Wait List ◽  
Web Based ◽  
Wait List Control ◽  
Integrative Health ◽  
Randomized Controlled

BACKGROUND Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. OBJECTIVE This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). METHODS This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. RESULTS Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. CONCLUSIONS This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. CLINICALTRIAL ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/13666

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. OBJECTIVE The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. METHODS This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. RESULTS The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. CONCLUSIONS The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21307

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial

10.2196/21307 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e21307
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. Objective The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. Methods This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. Results The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. Conclusions The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 International Registered Report Identifier (IRRID) DERR1-10.2196/21307

scholarly journals A Comparison of Users and Nonusers of a Web-Based Intervention for Carers of Older Persons With Alzheimer Disease and Related Dementias: Mixed Methods Secondary Analysis

10.2196/14254 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e14254 ◽  
Author(s):  
Wendy Duggleby ◽  
Jenny Ploeg ◽  
Carrie McAiney ◽  
Kathryn Fisher ◽  
Kathya Jovel Ruiz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Self Efficacy ◽  
Computer Literacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Analysis ◽  
Web Based ◽  
Telephone Interviews ◽  
Randomized Controlled

Background A self-administered Web-based intervention was developed to help carers of persons with Alzheimer disease and related dementias (ADRD) and multiple chronic conditions (MCC) deal with the significant transitions they experience. The intervention, My Tools 4 Care (MT4C), was evaluated during a pragmatic mixed methods randomized controlled trial with 199 carers. Those in the intervention group received free, password-protected access to MT4C for three months. MT4C was found to increase hope in participants at three months compared with the control group. However, in the intervention group, 22% (20/92) did not use MT4C at all during the three-month period. Objective This mixed methods secondary analysis aimed to (1) examine differences at three months in the outcomes of hope, self-efficacy, and health-related quality of life (HRQOL) scores in users (ie, those who used MT4C at least once during the three-month period) compared with nonusers and (2) identify reasons for nonuse. Methods Data from the treatment group of a pragmatic mixed methods randomized controlled trial were used. Through audiotaped telephone interviews, trained research assistants collected data on participants’ hope (Herth Hope Index; HHI), self-efficacy (General Self-Efficacy Scale; GSES), and HRQOL (Short-Form 12-item health survey version 2; SF-12v2) at baseline, one month, and three months. Treatment group participants also provided feedback on MT4C through qualitative telephone interviews at one month and three months. Analysis of covariance was used to determine differences at three months, and generalized estimating equations were used to determine significant differences in HHI, GSES, and SF-12v2 between users and nonusers of MT4C from baseline to three months. Interview data were analyzed using content analysis and integrated with quantitative data at the result stage. Results Of the 101 participants at baseline, 9 (9%) withdrew from the study, leaving 92 participants at three months of which 72 (78%) used MT4C at least once; 20 (22%) participants did not use it at all. At baseline, there were no statistically significant differences in demographic characteristics and in outcome variables (HHI, GSES, and SF-12v2 mental component score and physical component score) between users and nonusers. At three months, participants who used MT4C at least once during the three-month period (users) reported higher mean GSES scores (P=.003) than nonusers. Over time, users had significantly higher GSES scores than nonusers (P=.048). Reasons for nonuse of MT4C included the following: caregiving demands, problems accessing MT4C (poor connectivity, computer literacy, and navigation of MT4C), and preferences (for paper format or face-to-face interaction). Conclusions Web-based interventions, such as MT4C, have the potential to increase the self-efficacy of carers of persons with ADRD and MCC. Future research with MT4C should consider including educational programs for computer literacy and providing alternate ways to access MT4C in addition to Web-based access. Trial Registration ClinicalTrials.gov NCT02428387; https://clinicaltrials.gov/ct2/show/NCT02428387

scholarly journals Electronic Health Program to Empower Patients in Returning to Normal Activities After Colorectal Surgical Procedures: Mixed-Methods Process Evaluation Alongside a Randomized Controlled Trial

10.2196/10674 ◽  
2019 ◽  
Vol 21 (1) ◽  
pp. e10674 ◽  
Author(s):  
Chantal M den Bakker ◽  
Judith AF Huirne ◽  
Frederieke G Schaafsma ◽  
Charlotte de Geus ◽  
Hendrik J Bonjer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Surgical Procedures ◽  
Health Program ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Electronic Health

The Use of Web-Based Support Groups versus Usual Quit-Smoking Care for Men and Women 21–59 Years Old: A Protocol for a Randomized Controlled Trial

2019 ◽  
Author(s):  
Cornelia Pechmann ◽  
Douglas Calder ◽  
Connor Phillips ◽  
Kevin Delucchi ◽  
Judith J. Prochaska
Keyword(s):  
Randomized Controlled Trial ◽  
Support Groups ◽  
Controlled Trial ◽  
Web Based ◽  
Men And Women ◽  
Randomized Controlled ◽  
Quit Smoking

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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