scholarly journals Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care (Preprint)

2018 ◽  
Author(s):  
Susan Fletcher ◽  
Janine Clarke ◽  
Samineh Sanatkar ◽  
Peter Baldwin ◽  
Jane Gunn ◽  
...  
Keyword(s):  
Mental Health ◽  
Primary Care ◽  
Health Care ◽  
General Practice ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Web Based ◽  
Recruitment Methods ◽  
Face To Face ◽  
Randomized Controlled

BACKGROUND E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. OBJECTIVE This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. METHODS Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. RESULTS Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. CONCLUSIONS Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice.

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial

10.2196/15001 ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. e15001
Author(s):  
Sarah MacLean ◽  
Daniel J Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

Background Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. Objective We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. Methods We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). Results A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. Conclusions The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. Trial Registration ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

scholarly journals Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sarah MacLean ◽  
Daniel J. Corsi ◽  
Sadie Litchfield ◽  
Julia Kucharski ◽  
Kira Genise ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
Randomized Controlled

BACKGROUND Depression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression. OBJECTIVE We aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (<i>The Journal</i>) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks. METHODS We conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9). RESULTS A total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t<sub>91</sub>=−0.37; <i>P</i>=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t<sub>84</sub>=−2.73; <i>P</i>=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in <i>The Journal</i> and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in <i>The Journal</i>, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ<sup>2</sup><sub>1</sub>=6.3; <i>P</i>=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention. CONCLUSIONS The results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective. CLINICALTRIAL ClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

scholarly journals A Web-Based Mental Health Platform for Individuals Seeking Specialized Mental Health Care Services: Multicenter Pragmatic Randomized Controlled Trial

10.2196/10838 ◽  
2019 ◽  
Vol 21 (6) ◽  
pp. e10838 ◽  
Author(s):  
Jennifer M Hensel ◽  
James Shaw ◽  
Noah M Ivers ◽  
Laura Desveaux ◽  
Simone N Vigod ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Web Based ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Health Application ◽  
Specialized Mental Health

Background Web-based self-directed mental health applications are rapidly emerging to address health service gaps and unmet needs for information and support. Objective The aim of this study was to determine if a multicomponent, moderated Web-based mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. Methods A multicenter, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, aged 16 years or older, with access to the internet and an email address, and having the ability to navigate a Web-based mental health application were eligible. A total of 812 participants were randomized 2:1 to receive immediate (immediate treatment group, ITG) or delayed (delayed treatment group, DTG) access for 3 months to the Big White Wall (BWW), a multicomponent Web-based mental health intervention based in the United Kingdom and New Zealand. The primary outcome was the total score on the Recovery Assessment Scale, revised (RAS-r) which measures mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EuroQOL 5-dimension quality of life questionnaire (EQ-5D-5L), and the Community Integration Questionnaire. An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. Results Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (−1.83 points, 95% CI −2.85 to −0.82) and GAD-7 score (−1.55 points, 95% CI −2.42 to −0.70). Follow-up was achieved for 55% (446/812) at 3 months, 48% (260/542) of ITG participants and 69% (186/270) of DTG participants. Only 58% (312/542) of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. Conclusions The Web-based application may be beneficial; however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar Web-based interventions. Trial Registration ClinicalTrials.gov NCT02896894; https://clinicaltrials.gov/ct2/show/NCT02896894 (Archived by WebCite at http://www.webcitation.org/78LIpnuRO)

scholarly journals A web-based mental health platform in individuals seeking specialized mental health care services: multi-centre pragmatic randomized controlled trial (Preprint)

2018 ◽  
Author(s):  
Jennifer Hensel ◽  
James Shaw ◽  
Noah Ivers ◽  
Laura Desveaux ◽  
Simone Vigod ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Mental Health Care ◽  
Controlled Trial ◽  
Web Based ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Health Application ◽  
Specialized Mental Health

BACKGROUND Web-based self-directed mental health applications are rapidly emerging as a solution to health service gaps and unmet needs for information and support. OBJECTIVE The aim of this study was to determine if a multi-component web-based moderated mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. METHODS A multi-centre, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, 16 years of age or older, with access to the internet and an email address, and having the ability to navigate a web-based mental health application were eligible. 812 participants were randomized 2:1 to receive immediate (ITG) or delayed (DTG) access for 3 months to the Big White WallTM, a web-based multi-component mental health intervention based in the United Kingdom and New Zealand. The primary outcome was total score on the Recovery Assessment Scale, revised (RAS-r) measuring mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EQ-5D-5L, and the Community Integration Questionnaire (CIQ). An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. RESULTS Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (-1.83 points, 95% CI -2.85 to -0.82) and GAD-7 score (-1.55 points, 95% CI -2.42 to -0.70). Follow-up was achieved for 446 (55%) at 3 months; 48% of ITG participants, and 69% of DTG participants. Only 58% of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. CONCLUSIONS The web-based application may be beneficial, however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar web-based interventions. CLINICALTRIAL Clinicaltrials.gov NCT02896894. Registered on 31 August 2016 (retrospectively registered). https://clinicaltrials.gov/ct2/show/NCT02896894

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