Heartrate variability biofeedback for migraine using a smartphone application and sensor: A randomized controlled trial

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.Design and Methods: The study will be implemented as a randomized controlled trial. A total of 317 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU; or Group C: only TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B or Group C.Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, we expect that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT05102942?term=NCT05102942&draw=2&rank=1, identifier: NCT05102942.

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Digital instruments for reporting of gastrointestinal symptoms in clinical trials: comparison of end-of-day diaries versus experience sampling method (Preprint)

10.2196/preprints.31678 ◽

2021 ◽

Author(s):

Abraham B. Beckers ◽

Johanna T.W. Snijkers ◽

Zsa Zsa R.M. Weerts ◽

Lisa Vork ◽

Tim Klaassen ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Controlled Trial ◽

Irritable Bowel Syndrome ◽

Sampling Method ◽

Sampling Methods ◽

Controlled Trial ◽

Smartphone Application ◽

Randomized Controlled ◽

Pre Treatment ◽

Irritable Bowel

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.

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Effect of a Novel Smartphone Application on Breastfeeding Rates Among Low-Income, First-Time Mothers Intending to Exclusively Breastfeed: Secondary Analysis of a Randomized Controlled Trial

Breastfeeding Medicine ◽

10.1089/bfm.2020.0240 ◽

2020 ◽

Author(s):

Adam K. Lewkowitz ◽

Julia D. López ◽

Erika F. Werner ◽

Megan L. Ranney ◽

George A. Macones ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Low Income ◽

Controlled Trial ◽

Secondary Analysis ◽

Smartphone Application ◽

Randomized Controlled ◽

First Time Mothers ◽

Breastfeeding Rates ◽

First Time

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

BMC Sports Science Medicine and Rehabilitation ◽

10.1186/s13102-019-0148-2 ◽

2019 ◽

Vol 11 (1) ◽

Cited By ~ 2

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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Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial

Trials ◽

10.1186/s13063-020-04778-1 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Victoria Ka-Ying Hui ◽

Christy Yim-Fan Wong ◽

Eric Ka-Yiu Ma ◽

Fiona Yan-Yee Ho ◽

Christian S. Chan

Keyword(s):

Randomized Controlled Trial ◽

Hong Kong ◽

Major Depression ◽

Cognitive Behavioral Therapy ◽

Behavioral Therapy ◽

Controlled Trial ◽

Smartphone Application ◽

Cognitive Behavioral ◽

Randomized Controlled ◽

Self Help

Abstract Background Depression is a major public health concern. Emerging research has shown that cognitive behavioral therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper reports a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, using a waitlist group as control, for people with major depression and insomnia. Methods A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow-up. The recruitment is completed. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I intervention. Discussion It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, thereby reducing the burden of the public healthcare system in Hong Kong. Trial registration ClinicalTrials.gov NCT04228146. Retrospectively registered on 14 January 2020.

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