scholarly journals Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Mathias Harrer ◽  
Sophia Helen Adam ◽  
Rebecca Jessica Fleischmann ◽  
Harald Baumeister ◽  
Randy Auerbach ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Waitlist Control ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mental health problems are highly prevalent among college students. Most students with poor mental health, however, do not receive professional help. Internet-based self-help formats may increase the utilization of treatment. OBJECTIVE The aim of this randomized controlled trial was to evaluate the efficacy of an internet-based, app-supported stress management intervention for college students. METHODS College students (n=150) with elevated levels of stress (Perceived Stress Scale 4-item version, PSS-4 ≥8) were randomly assigned to either an internet- and mobile-based stress intervention group with feedback on demand or a waitlist control group. Self-report data were assessed at baseline, posttreatment (7 weeks), and 3-month follow-up. The primary outcome was perceived stress posttreatment (PSS-4). Secondary outcomes included mental health outcomes, modifiable risk and protective factors, and college-related outcomes. Subgroup analyses were conducted in students with clinically relevant symptoms of depression (Center for Epidemiological Studies’ Depression Scale >17). RESULTS A total of 106 participants (76.8%) indicated that they were first-time help-seekers, and 77.3% (intervention group: 58/75; waitlist control group: 58/75) showed clinically relevant depressive symptoms at baseline. Findings indicated significant effects of the intervention compared with the waitlist control group for stress (d=0.69; 95% CI 0.36-1.02), anxiety (d=0.76; 95% CI 0.43-1.09), depression (d=0.63; 95% CI 0.30-0.96), college-related productivity (d=0.33; 95% CI 0.01-0.65), academic work impairment (d=0.34; 95% CI 0.01-0.66), and other outcomes after 7 weeks (posttreatment). Response rates for stress symptoms were significantly higher for the intervention group (69%, 52/75) compared with the waitlist control group (35%, 26/75, P<.001; number needed to treat=2.89, 95% CI 2.01-5.08) at posttest (7 weeks). Effects were sustained at 3-month follow-up, and similar findings emerged in students with symptoms of depression. CONCLUSIONS Internet- and mobile-based interventions could be an effective and cost-effective approach to reduce consequences of college-related stress and might potentially attract students with clinically relevant depression who would not otherwise seek help. CLINICALTRIAL German Clinical Trial Register DRKS00010212; http://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010212 (Archived by WebCite at http://www.webcitation.org/6w55Ewhjd)

scholarly journals Implementation and Effects of an Information Technology-Based Intervention to Support Speech and Language Therapy Among Stroke Patients with Aphasia: Protocol for a Virtual Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Esther Kim ◽  
Laura Laird ◽  
Carlee Wilson ◽  
Till Bieg ◽  
Phillip Mildner ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Lexical Retrieval ◽  
Evidence Based ◽  
Waitlist Control ◽  
Treatment Assessment ◽  
Randomized Controlled ◽  
Waitlist Control Group

BACKGROUND Mobile application-based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia (PwA) as an adjunct or in lieu of traditional in-person therapy approaches. These apps can increase the intensity of treatment, and have been shown to result in meaningful outcomes across several domains OBJECTIVE VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to engage PwA to improve their naming abilities through interaction with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia. METHODS A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. Intervention group participants will engage in five weeks of training with the app, followed by post-treatment assessment and follow-up assessment after an additional five weeks. Those in the waitlist control group will have five weeks of no training, followed by a pre-treatment assessment, training for five weeks and post-treatment assessment. All aspects of the trial are being conducted remotely given the COVID-19 pandemic. RESULTS Recruitment of participants started in September 2020 and the study is expected to be completed by March 2022. Publication of results is expected within six months of study completion. CONCLUSIONS Results of the RCT will provide data to inform evidence-based practice on the use of technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in PwA within an easily accessible, cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can inform the profession on telerehabilitation practices and monitoring app-based home therapy programs. CLINICALTRIAL ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364

scholarly journals A Mobile Health Intervention for Mental Health Promotion Among University Students: Randomized Controlled Trial

10.2196/17208 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e17208 ◽  
Author(s):  
Marcus Bendtsen ◽  
Ulrika Müssener ◽  
Catharina Linderoth ◽  
Kristin Thomas
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Positive Mental Health ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled

Background High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one’s community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population. Objective The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design. Methods A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants’ mobile phones. Results A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables. Conclusions The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion. Trial Registration International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632

scholarly journals Efficacy of a web application for stress management among Iranian college students during COVID-19 outbreak: a study protocol for randomized controlled trials

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Fatemeh Khademian ◽  
Azam Aslani ◽  
Ramin Ravangard ◽  
Peivand Bastani ◽  
Mohammad Nami ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Sleep Quality ◽  
Stress Management ◽  
Web Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
And Control

Abstract Background The prevalence of mental health disorders is increasing globally, and the prevalence of COVID-19 has made it worse. Evidence has indicated a major mental health burden and elevated anxiety associated with the new coronavirus outbreak in the general population. This study aims to evaluate an evidence-based web application (Naranj) for stress management among Iranian college students. Methods and design This study aims to present a protocol related to a randomized controlled trial among Iranian college students. The study will be conducted on 100 students from two colleges of Shiraz University of Medical Sciences in Iran. The participants will be randomly assigned to the intervention and control groups. The intervention group participants will be provided with a web application, whereas the control group ones will be provided with an app unrelated to stress management. The primary outcome for this study will be the Perceived Stress Scale, and the two groups will be compared with respect to stress level and sleep quality. Discussion A web application will be developed according to psychological theories and will be scientifically approved for managing college students’ stress and improving their sleep quality during the COVID-19 outbreak. Trial registration Iranian Registry of Clinical Trials IRCT20160427027647N2. Registered on 14 May 2020

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.

Effect of ICT-Based Self-Management System DialBeticsLite on Treating Abdominal Obesity: Randomized Controlled Trial. (Preprint)

2021 ◽  
Author(s):  
Masahiro Kondo ◽  
Teru Okitsu ◽  
Kayo Waki ◽  
Toshimasa Yamauchi ◽  
Masaomi Nangaku ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Metabolic Parameters ◽  
Control Group ◽  
Physical Parameters ◽  
Lifestyle Behavior ◽  
Randomized Controlled

BACKGROUND Mobile health interventions, a more cost-effective approach compared to traditional methods of delivering lifestyle coaching in person, have been shown to improve physical parameters and lifestyle behavior among overweight populations. It is useful to know the efficacy of mobile apps in treating abdominal obesity, as it is a known risk factor for metabolic disorders and type 2 diabetes. OBJECTIVE This study aimed to determine whether a mobile self-management app (DialBeticsLite) could be used by patients with abdominal obesity to achieve a reduction in visceral fat area (VFA) and other physical parameters. METHODS This study was an open-label, 2-arm parallel-design randomized controlled trial. We recruited 122 people in September 2017, and randomly assigned them into either the intervention group or the control group. All participants attended an educational group session, which delivered information regarding diet and exercise. Additionally, participants in the intervention group were asked to use DialBeticsLite for 3 months. DialBeticsLite facilitated the daily recording of several physical parameters and lifestyle behavior, and provided feedback to encourage an improvement in behavior. The primary outcome was the change in VFA from baseline to the 3-month follow-up. Secondary outcomes included changes in both physical and metabolic parameters, from baseline to the 3-month follow-up. Welch t test was conducted to analyze the effects of DialBeticsLite on both the primary outcome and the secondary outcomes. RESULTS Out of the 122 participants recruited, 75 participants were analyzed due to 47 participants being excluded: 37 due to ineligibility and 10 due to withdrawal of consent. The mean age was 49.3 (standard deviation: SD 6.1) in the intervention group (n=41) and 48.5 (SD 5.3) in the control group (n=34), and all participants were male, though unintentionally. Baseline characteristics did not differ significantly between the intervention and control group, except for VFA. The averaged change of VFA was -23.5cm2 (SD 20.6) in the intervention group and +1.9cm2 (SD 16.2) in the control group (P<.001). Statistically significant differences were also found for the change of body weight, BMI and waist circumference. These findings did not change after adjusting for VFA at baseline. The intervention had no significant effect on any of the metabolic parameters. An exploratory analysis showed significant associations between the change in VFA and steps per day, and between the change in VFA and calorie intake per day within the intervention group. CONCLUSIONS Our findings indicate that although unsuccessful in improving metabolic parameters, a mobile health intervention facilitating the daily monitoring of several physical parameters and lifestyle behavior, can be highly effective in inducing visceral fat loss and weight loss among adults with abdominal obesity. CLINICALTRIAL Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000042045 Retrospectively Registered; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000046495&type=summary&llanguag=J

Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

2021 ◽  
Author(s):  
Angela Chu ◽  
Tyler M Rose ◽  
Danielle A Gundrum ◽  
Tressa E McMorris ◽  
Eytan A Klausner ◽  
...  
Keyword(s):  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Intervention Period ◽  
Entire Study ◽  
Positive Effects ◽  
Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

Effect of psychoeducation website named “Imacoco-care” on improving psychological distress among workers under COVID-19 pandemic: a randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Kotaro Imamura ◽  
Natsu Sasaki ◽  
Yuki Sekiya ◽  
Kazuhiro Watanabe ◽  
Asuka Sakuraya ◽  
...  
Keyword(s):  
Mental Health ◽  
Adverse Effect ◽  
Psychological Distress ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychoeducational Intervention ◽  
Favorable Effect ◽  
Randomized Controlled ◽  
Small Effect Size

BACKGROUND The prolonged coronavirus disease 2019 (COVID-19) pandemic affected mental health among workers. Psychoeducational intervention via an Internet website could be effective for primary prevention of mental health among workers in the current COVID-19 pandemic. OBJECTIVE The aim of this randomized controlled trial (RCT) was to examine the effect of a newly developed online psychoeducational website named "Imacoco-care" on reducing psychological distress and fear about COVID-19 infection among workers. METHODS Participants in the present study were recruited from registered members of a web survey company in Japan. Participants who fulfilled the eligibility criteria were randomly allocated to intervention or control groups. Participants in the intervention group were invited to access the Imacoco-care within a month after the baseline survey. Kessler’s Psychological Distress Scale (K6) and The Fear of COVID-19 Scale (FCV-19S) were obtained at baseline, 1-, and 3-month follow-ups. RESULTS A total of 1200 workers were randomly allocated to an intervention or control group (n = 600 for each). In the intention-to-treat (ITT) analyses, the Imacoco-care showed significant favorable effect on K6 (p = 0.03) with small effect size (d = -0.14), and adverse effect on FCV-19S (p = 0.01) with small effect size (d = 0.16) in the intervention group at 3-month follow-up. In the per-protocol analyses (only included participants who have read the Imacoco-care at least one time), the Imacoco-care also showed significant favorable effect on reducing K6 (p = 0.03), while adverse effect on FCV-19S was not significant (p = 0.06) in the intervention group at 3-month follow-up. CONCLUSIONS A web-based psychoeducation approach may be effective on improving psychological distress in a general working population, while it may be important not only distributing information but also encouraging to access and see the contents to prevent the adverse effect of psychoeducational intervention. CLINICALTRIAL The University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The registration number is UMIN000042556 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048548).

scholarly journals StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ann-Marie Küchler ◽  
Dana Schultchen ◽  
Olga Pollatos ◽  
Morten Moshagen ◽  
David D. Ebert ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Population Level ◽  
Control Group ◽  
Cognitive Fusion ◽  
On Demand ◽  
Randomized Controlled ◽  
Increased Risk

Abstract Background College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work. Methods In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles. Discussion Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content. Trial registration WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774. Registered on 18 May 2018.

Effectiveness of Prompt Mental Health Care: Preliminary results from a randomized controlled trial

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Knapstad ◽  
L V Lervik ◽  
S M M Saether ◽  
L E Aaroe ◽  
O R F Smith
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Randomized Controlled Trial ◽  
Mental Health Care ◽  
Controlled Trial ◽  
Sensitivity Analyses ◽  
Depression And Anxiety ◽  
Symptoms Of Depression ◽  
Randomized Controlled

Abstract Background Prompt Mental Health Care (PMHC) service is a Norwegian initiative, adapted from the English ‘Improved Access to Psychological Therapy’ (IAPT), aimed at improving access to primary care treatment for anxiety and depression. Thus far, both PMHC and IAPT have been evaluated by cohort studies only. Albeit yielding promising results, the extent to which these are attributable to the treatment thus remains unsettled. This study investigates the effectiveness of PMHC compared to treatment as usual (TAU) at six months follow-up. Methods Randomized controlled trial with parallel assignment in two PMHC sites from November 2015 to March 2018. Participants were 681 adults (aged ≥18 years) considered for admission to PMHC due to anxiety and/or mild to moderate depression. These were randomly assigned on a 70:30 ratio. Main outcomes were recovery rates and changes in symptoms of depression and anxiety between baseline and follow-up. Primary outcome data were available for 73%/67% in the PMHC/TAU group. Sensitivity analyses based on observed patterns of missingness were conducted. Results A reliable recovery rate of 58.5% was observed in the PMHC group and 31.9% in the TAU group, yielding a between-group effect size (ES) of 0.61 [95% CI 0.37-0.85, p&lt;.001]. The differences in degree of improvement between PMHC and TAU yielded an ES of -0.88 [95% CI -1.23-0.43, p &lt; 0.001] for symptoms of depression and -0.60 [95% CI -0.90-0.30, p &lt; 0.001] for symptoms of anxiety in favour of PMHC. All sensitivity analyses pointed in the same direction with small variations in point estimates. Findings were slightly more robust for depressive than anxiety symptoms. Conclusions The PMHC treatment was substantially more effective than TAU in alleviating symptoms of anxiety and depression. This adaptation of IAPT is considered a viable supplement to existing health services to increase access of effective treatment for adults who suffer from anxiety and mild to moderate depression. Key messages This study is the first to evaluate the effectiveness of an IAPT-like treatment model in terms of a randomized controlled trial. Prompt Mental Health Care was substantially more effective than TAU in alleviating symptoms of depression and anxiety at 6-months follow-up.

scholarly journals Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Pernille Lunde ◽  
Asta Bye ◽  
Astrid Bergland ◽  
Birgitta Blakstad Nilsson
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Control Group ◽  
Power Calculation ◽  
Large Sample Size ◽  
Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

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