Mobile Data Collection of Cognitive-Behavioral Tasks in Substance Use Disorders: Where Are We Now?

INTRODUCTION: Over the last decades, our understanding of the cognitive, motivational, and neural processes involved in addictive behavior has increased enormously. A plethora of laboratory-based and cross-sectional studies has linked cognitive-behavioral measures to between-subject differences in drinking behavior. However, such laboratory-based studies inevitably suffer from small sample sizes and the inability to link temporal fluctuations in task measures to fluctuations in real-life substance use. To overcome these problems, several existing behavioral tasks have been transferred to smartphones to allow studying cognition in the field. METHOD: In this narrative review, we first summarize studies that used existing behavioral tasks in the laboratory and self-reports of substance use with ecological momentary assessment (EMA) in the field. Next, we review studies on psychometric properties of smartphone-based behavioral tasks. Finally, we review studies that used both smartphone-based tasks and self-reports with EMA in the field. RESULTS: Overall, studies were scarce and heterogenous both in tasks and in study outcomes. Nevertheless, existing findings are promising and point toward several methodological recommendations: concerning psychometrics, studies show that - although more systematic studies are necessary - task validity and reliability can be improved, for example, by analyzing several measurement sessions at once rather than analyzing sessions separately. Studies that use tasks in the field, moreover, show that power can be improved by choosing sampling schemes that combine time-based with event-based sampling, rather than relying on time-based sampling alone. Increasing sampling frequency can further increase power. However, as this also increases the burden to participants, more research is necessary to determine the ideal sampling frequency for each task. CONCLUSION: Although more research is necessary to systematically study both the psychometrics of smartphone-based tasks and the frequency at which task measures fluctuate, existing studies are promising and reveal important methodological recommendations useful for researchers interested in implementing behavioral tasks in EMA studies

Mobile Data Collection of Cognitive-Behavioral Tasks in Substance Use Disorders: Where Are We Now?

Introduction: Over the last decades, our understanding of the cognitive, motivational, and neural processes involved in addictive behavior has increased enormously. A plethora of laboratory-based and cross-sectional studies has linked cognitive-behavioral measures to between-subject differences in drinking behavior. However, such laboratory-based studies inevitably suffer from small sample sizes and the inability to link temporal fluctuations in task measures to fluctuations in real-life substance use. To overcome these problems, several existing behavioral tasks have been transferred to smartphones to allow studying cognition in the field. Method: In this narrative review, we first summarize studies that used existing behavioral tasks in the laboratory and self-reports of substance use with ecological momentary assessment (EMA) in the field. Next, we review studies on psychometric properties of smartphone-based behavioral tasks. Finally, we review studies that used both smartphone-based tasks and self-reports with EMA in the field. Results: Overall, studies were scarce and heterogenous both in tasks and in study outcomes. Nevertheless, existing findings are promising and point toward several methodological recommendations: concerning psychometrics, studies show that – although more systematic studies are necessary – task validity and reliability can be improved, for example, by analyzing several measurement sessions at once rather than analyzing sessions separately. Studies that use tasks in the field, moreover, show that power can be improved by choosing sampling schemes that combine time-based with event-based sampling, rather than relying on time-based sampling alone. Increasing sampling frequency can further increase power. However, as this also increases the burden to participants, more research is necessary to determine the ideal sampling frequency for each task. Conclusion: Although more research is necessary to systematically study both the psychometrics of smartphone-based tasks and the frequency at which task measures fluctuate, existing studies are promising and reveal important methodological recommendations useful for researchers interested in implementing behavioral tasks in EMA studies

Digital mental health: challenges and next steps

Digital innovations in mental health offer great potential, but present unique challenges. Using a consensus development panel approach, an expert, international, cross-disciplinary panel met to provide a framework to conceptualise digital mental health innovations, research into mechanisms and effectiveness and approaches for clinical implementation. Key questions and outputs from the group were agreed by consensus, and are presented and discussed in the text and supported by case examples in an accompanying appendix. A number of key themes emerged. (1) Digital approaches may work best across traditional diagnostic systems: we do not have effective ontologies of mental illness and transdiagnostic/symptom-based approaches may be more fruitful. (2) Approaches in clinical implementation of digital tools/interventions need to be creative and require organisational change: not only do clinicians and patients need training and education to be more confident and skilled in using digital technologies to support shared care decision-making, but traditional roles need to be extended, with clinicians working alongside digital navigators and non-clinicians who are delivering protocolised treatments. (3) Designing appropriate studies to measure the effectiveness of implementation is also key: including digital data raises unique ethical issues, and measurement of potential harms is only just beginning. (4) Accessibility and codesign are needed to ensure innovations are long lasting. (5) Standardised guidelines for reporting would ensure effective synthesis of the evidence to inform clinical implementation. COVID-19 and the transition to virtual consultations have shown us the potential for digital innovations to improve access and quality of care in mental health: now is the ideal time to act

Daily patterns of fatigue after subarachnoid haemorrhage: an ecological momentary assessment study

Objective: To examine the daily course of, and factors associated with, momentary fatigue after subarachnoid haemorrhage, and to explore subgroups of patients with distinct diurnal patterns of fatigue. Design: Observational study using ecological momentary assessment. Subjects: A total of 41 participants with subarachnoid haemorrhage. Methods: Patients with fatigue were included within one year post-onset. Momentary fatigue (scale 1–7) was assessed with repeated measurements (10–11 times/day) during 7 consecutive days. Multilevel-mixed-model analyses and latent-class trajectory modelling were conducted. Results: Mean (standard deviation; SD) age of the group was 53.9 (13.0) years, 56% female, and mean (SD) time post-subarachnoid haemorrhage onset was 9.3 (3.2) months. Mean (SD) momentary fatigue over all days was 3.22 (1.47). Fatigue increased significantly (p < 0.001) over the day, and experiencing more burden of fatigue and day type (working day vs weekend day) were significantly (p < 0.05) associated with higher momentary fatigue. Three subgroups could be distinguished based on diurnal patterns of fatigue. The largest group (n = 17, 41.5%) showed an increasing daily pattern of fatigue. Conclusion: Momentary fatigue in patients with subarachnoid haemorrhage increases over the day, and diurnal patterns of fatigue differ between participants. In addition to conventional measures, momentary measures of fatigue might provide valuable information for physicians to optimize personalized management of fatigue after subarachnoid haemorrhage

Association of Locomotor Activity During Sleep Deprivation Treatment With Response

Disrupted circadian rhythms and sleep patterns are frequently observed features of psychiatric disorders, and especially mood disorders. Sleep deprivation treatment (SD) exerts rapid but transient antidepressant effects in depressed patients and has gained recognition as a model to study quick-acting antidepressant effects. It is of interest how locomotor activity patterns during SD might be associated with and potentially predict treatment response. The present study is an analysis of locomotor activity data, previously collected over a 24 h period, to examine the night of SD (Trautmann et al. 2018) as mood disorder patients suffering from a depressive episode (n = 78; after exclusions n = 59) underwent SD. In this exploratory analysis, the associations between response to SD, locomotor activity, and subjective mood during the 24 h period of SD were explored. Higher levels of activity overall were observed in non-responders (n = 18); in particular, non-responders moved more during the evening of SD until midnight and remained high thereafter. In contrast, activity in responders (n = 41) decreased during the evening and increased in the morning. Subjective mood was not found to be associated with locomotor activity. The window of data available in this analysis being limited, additional data from before and after the intervention are required to fully characterize the results observed. The present results hint at the possible utility of locomotor activity as a predictor and early indicator of treatment response, and suggest that the relationship between SD and locomotor activity patterns should be further investigated

Assessment of 24-hour physical behaviour in children and adolescents via wearables: a systematic review of free-living validation studies.

Objectives Studies that assess all three dimensions of the integrative 24-hour physical behaviour (PB) construct, namely, intensity, posture/activity type and biological state, are on the rise. However, reviews on validation studies that cover intensity, posture/activity type and biological state assessed via wearables are missing. Design Systematic review. The risk of bias was evaluated by using the QUADAS-2 tool with nine signalling questions separated into four domains (ie, patient selection/study design, index measure, criterion measure, flow and time). Data sources Peer-reviewed validation studies from electronic databases as well as backward and forward citation searches (1970-July 2021). Eligibility criteria for selecting studies Wearable validation studies with children and adolescents (age <18 years). Required indicators: (1) study protocol must include real-life conditions; (2) validated device outcome must belong to one dimension of the 24-hour PB construct; (3) the study protocol must include a criterion measure; (4) study results must be published in peer-reviewed English language journals. Results Out of 13 285 unique search results, 76 articles with 51 different wearables were included and reviewed. Most studies (68.4%) validated an intensity measure outcome such as energy expenditure, but only 15.9% of studies validated biological state outcomes, while 15.8% of studies validated posture/activity type outcomes. We identified six wearables that had been used to validate outcomes from two different dimensions and only two wearables (ie, ActiGraph GT1M and ActiGraph GT3X+) that validated outcomes from all three dimensions. The percentage of studies meeting a given quality criterion ranged from 44.7% to 92.1%. Only 18 studies were classified as 'low risk' or 'some concerns'. Summary Validation studies on biological state and posture/activity outcomes are rare in children and adolescents. Most studies did not meet published quality principles. Standardised protocols embedded in a validation framework are needed. PROSPERO registration number CRD42021230894

Assessment of 24-hour physical behaviour in children and adolescents via wearables: a systematic review of free-living validation studies

Objectives: Studies that assess all three dimensions of the integrative 24-hour physical behaviour (PB) construct, namely, intensity, posture/activity type and biological state, are on the rise. However, reviews on validation studies that cover intensity, posture/activity type and biological state assessed via wearables are missing. Design: Systematic review. The risk of bias was evaluated by using the QUADAS-2 tool with nine signalling questions separated into four domains (ie, patient selection/study design, index measure, criterion measure, flow and time). Data sources: Peer-reviewed validation studies from electronic databases as well as backward and forward citation searches (1970–July 2021). Eligibility criteria for selecting studies: Wearable validation studies with children and adolescents (age <18 years). Required indicators: (1) study protocol must include real-life conditions; (2) validated device outcome must belong to one dimension of the 24-hour PB construct; (3) the study protocol must include a criterion measure; (4) study results must be published in peer-reviewed English language journals. Results: Out of 13 285 unique search results, 76 articles with 51 different wearables were included and reviewed. Most studies (68.4%) validated an intensity measure outcome such as energy expenditure, but only 15.9% of studies validated biological state outcomes, while 15.8% of studies validated posture/activity type outcomes. We identified six wearables that had been used to validate outcomes from two different dimensions and only two wearables (ie, ActiGraph GT1M and ActiGraph GT3X+) that validated outcomes from all three dimensions. The percentage of studies meeting a given quality criterion ranged from 44.7% to 92.1%. Only 18 studies were classified as ‘low risk’ or ‘some concerns’. Summary: Validation studies on biological state and posture/activity outcomes are rare in children and adolescents. Most studies did not meet published quality principles. Standardised protocols embedded in a validation framework are needed

Quality Evaluation of Free-living Validation Studies for the Assessment of 24-Hour Physical Behavior in Adults via Wearables: Systematic Review.

BACKGROUND Wearable technology is a leading fitness trend in the growing commercial industry and an established method for collecting 24-hour physical behavior data in research studies. High-quality free-living validation studies are required to enable both researchers and consumers to make guided decisions on which study to rely on and which device to use. However, reviews focusing on the quality of free-living validation studies in adults are lacking. OBJECTIVE This study aimed to raise researchers' and consumers' attention to the quality of published validation protocols while aiming to identify and compare specific consistencies or inconsistencies between protocols. We aimed to provide a comprehensive and historical overview of which wearable devices have been validated for which purpose and whether they show promise for use in further studies. METHODS Peer-reviewed validation studies from electronic databases, as well as backward and forward citation searches (1970 to July 2021), with the following, required indicators were included: protocol must include real-life conditions, outcome must belong to one dimension of the 24-hour physical behavior construct (intensity, posture or activity type, and biological state), the protocol must include a criterion measure, and study results must be published in English-language journals. The risk of bias was evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2 tool with 9 questions separated into 4 domains (patient selection or study design, index measure, criterion measure, and flow and time). RESULTS Of the 13,285 unique search results, 222 (1.67%) articles were included. Most studies (153/237, 64.6%) validated an intensity measure outcome such as energy expenditure. However, only 19.8% (47/237) validated biological state and 15.6% (37/237) validated posture or activity-type outcomes. Across all studies, 163 different wearables were identified. Of these, 58.9% (96/163) were validated only once. ActiGraph GT3X/GT3X+ (36/163, 22.1%), Fitbit Flex (20/163, 12.3%), and ActivPAL (12/163, 7.4%) were used most often in the included studies. The percentage of participants meeting the quality criteria ranged from 38.8% (92/237) to 92.4% (219/237). On the basis of our classification tree to evaluate the overall study quality, 4.6% (11/237) of studies were classified as low risk. Furthermore, 16% (38/237) of studies were classified as having some concerns, and 72.9% (173/237) of studies were classified as high risk. CONCLUSIONS Overall, free-living validation studies of wearables are characterized by low methodological quality, large variability in design, and focus on intensity. Future research should strongly aim at biological state and posture or activity outcomes and strive for standardized protocols embedded in a validation framework. Standardized protocols for free-living validation embedded in a framework are urgently needed to inform and guide stakeholders (eg, manufacturers, scientists, and consumers) in selecting wearables for self-tracking purposes, applying wearables in health studies, and fostering innovation to achieve improved validity

Quality Evaluation of Free-living Validation Studies for the Assessment of 24-Hour Physical Behavior in Adults via Wearables: Systematic Review

Background: Wearable technology is a leading fitness trend in the growing commercial industry and an established method for collecting 24-hour physical behavior data in research studies. High-quality free-living validation studies are required to enable both researchers and consumers to make guided decisions on which study to rely on and which device to use. However, reviews focusing on the quality of free-living validation studies in adults are lacking. Objective: This study aimed to raise researchers’ and consumers’ attention to the quality of published validation protocols while aiming to identify and compare specific consistencies or inconsistencies between protocols. We aimed to provide a comprehensive and historical overview of which wearable devices have been validated for which purpose and whether they show promise for use in further studies. Methods: Peer-reviewed validation studies from electronic databases, as well as backward and forward citation searches (1970 to July 2021), with the following, required indicators were included: protocol must include real-life conditions, outcome must belong to one dimension of the 24-hour physical behavior construct (intensity, posture or activity type, and biological state), the protocol must include a criterion measure, and study results must be published in English-language journals. The risk of bias was evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2 tool with 9 questions separated into 4 domains (patient selection or study design, index measure, criterion measure, and flow and time). Results: Of the 13,285 unique search results, 222 (1.67%) articles were included. Most studies (153/237, 64.6%) validated an intensity measure outcome such as energy expenditure. However, only 19.8% (47/237) validated biological state and 15.6% (37/237) validated posture or activity-type outcomes. Across all studies, 163 different wearables were identified. Of these, 58.9% (96/163) were validated only once. ActiGraph GT3X/GT3X+ (36/163, 22.1%), Fitbit Flex (20/163, 12.3%), and ActivPAL (12/163, 7.4%) were used most often in the included studies. The percentage of participants meeting the quality criteria ranged from 38.8% (92/237) to 92.4% (219/237). On the basis of our classification tree to evaluate the overall study quality, 4.6% (11/237) of studies were classified as low risk. Furthermore, 16% (38/237) of studies were classified as having some concerns, and 72.9% (173/237) of studies were classified as high risk. Conclusions: Overall, free-living validation studies of wearables are characterized by low methodological quality, large variability in design, and focus on intensity. Future research should strongly aim at biological state and posture or activity outcomes and strive for standardized protocols embedded in a validation framework. Standardized protocols for free-living validation embedded in a framework are urgently needed to inform and guide stakeholders (eg, manufacturers, scientists, and consumers) in selecting wearables for self-tracking purposes, applying wearables in health studies, and fostering innovation to achieve improved validity

START adolescents: study protocol of a randomised controlled trial to investigate the efficacy of a low-threshold group treatment programme in traumatised adolescent refugees

Introduction No evaluated therapeutic approaches, that can efficiently be established in routine mental healthcare, are currently available for traumatised adolescent refugees in Germany. This study evaluates the efficacy of the Stress-Traumasymptoms-Arousal-Regulation-Treatment (START) programme to reduce trauma-related symptoms and psychological distress in traumatised adolescent refugees based in Germany. Methods and analysis This randomised, waiting-list-controlled, multicentre trial with a 12-week follow-up will include 174 refugee minors with partial or full post-traumatic stress disorder who are fluent in either Arabic, Dari, English, German or Somali. Eligible refugee minors will be randomised to the START or waiting-list control groups. The manualised 8-week START programme is based on techniques of dialectical behaviour therapy (DBT), fosters adaptive coping with emotional distress and traumatic symptoms and comprises eight therapy modules and a booster session. Study assessments are planned at baseline, post-treatment (ie, after programme participation or waiting time), booster session at week 12 or 12-week waiting time, and at the 12-week follow-up. Primary and coprimary outcomes are changes in psychological distress and traumatic symptoms at post-treatment and will be analysed as response variables in linear mixed regression models. Secondary outcomes are changes in further trauma-related and other psychopathological symptoms, emotion regulation and intermediate effects of the programme at follow-up. We will also assess effects of the programme with ecological momentary assessments and on neuroendocrine stress parameters using hair cortisol. Ethics and dissemination This study has been approved by the lead ethics committee of Rhineland-Palatinate and the ethics committees of participating sites. The study results will be disseminated through peer-reviewed publications and scientific conferences