Investigating the efficacy of an individualized metacognitive therapy program (MCT+) for psychosis: study protocol of a multi-center randomized controlled trial.

BACKGROUND: Psychological interventions are increasingly recommended as adjunctive treatments for psychosis, but their implementation in clinical practice is still insufficient. The individualized metacognitive therapy program (MCT+; www.uke.de/mct_plus ) represents a low-threshold psychotherapeutic approach that synthesizes group metacognitive training (MCT) and cognitive behavioral therapy for psychosis, and addresses specific cognitive biases that are involved in the onset and maintenance of psychosis. It aims to "plant the seed of doubt" regarding rigid delusional convictions and to encourage patients to critically reflect, extend and change their approach to problem solving. Its second edition also puts more emphasis on affective symptoms. A recent meta-analysis of metacognitive interventions (MCT, MCT+) indicate small to moderate effects on positive symptoms and delusions, as well as high rates of acceptance. Nonetheless, no long-term studies of MCT+ involving large samples have been conducted. METHODS: The goal of the present multi-center, observer-blind, parallel-group, randomized controlled trial is to compare the efficacy of MCT+ against an active control (cognitive remediation; MyBrainTraining(©)) in 328 patients with psychosis at three time points (baseline, immediately after intervention [6 weeks] and 6 months later). The primary outcome is change in psychosis symptoms over the 6-month follow-up period as assessed by the delusion subscale of the Psychotic Symptom Rating Scale. Secondary outcomes include jumping to conclusions, other positive symptoms of schizophrenia, depressive symptoms, self-esteem, quality of life, and cognitive insight. The study also seeks to elucidate mediating factors that promote versus impede symptom improvement across time. DISCUSSION: This is the first multi-center randomized controlled trial to test the efficacy of individualized MCT+ in a large sample of patients with psychosis. The rationale for the trial, the design, and the strengths and limitations of the study are discussed. TRIAL REGISTRATION: The trial is registered through the German Clinical Trials Register ( www.drks.de ) as DRKS00008001 . Registered 6 May 2015.

Dopamine effects on evidence gathering and integration.

BACKGROUND: Disturbances in evidence gathering and disconfirmatory evidence integration have been associated with the presence of or propensity for delusions. Previous evidence suggests that these 2 types of reasoning bias might be differentially affected by antipsychotic medication. We aimed to investigate the effects of a dopaminergic agonist (L-dopa) and a dopaminergic antagonist (haloperidol) on evidence gathering and disconfirmatory evidence integration after single-dose administration in healthy individuals. METHODS: The study used a randomized, double-blind, placebo-controlled, 3-way crossover design. Participants were healthy individuals aged 18-40 years. We administered a new data-gathering task designed to increase sensitivity to change compared with traditional tasks. The Bias Against Disconfirmatory Evidence (BADE) task was used as a measure of disconfirmatory evidence integration. RESULTS: We included 30 individuals in our study. In the data-gathering task, dopaminergic modulation had no significant effect on the amount of evidence gathered before reaching a decision. In contrast, the ability of participants to integrate disconfirmatory evidence showed a significant linear dopaminergic modulation pattern (highest with haloperidol, intermediate with placebo, lowest with L-dopa), with the difference between haloperidol and L-dopa marginally reaching significance. LIMITATIONS: Although the doses used for haloperidol and L-dopa were similar to those used in previous studies, drug plasma level measurements would have added to the validity of findings. CONCLUSION: Evidence gathering and disconfirmatory evidence integration might be differentially influenced by dopaminergic agents. Our findings are in support of a dual-disturbance account of delusions and provide a plausible neurobiological basis for the use of interventions targeted at improving reasoning biases as an adjunctive treatment in patients with psychotic disorders.

Predictors of Retest Effects in a Longitudinal Study of Cognitive Aging in a Diverse Community-Based Sample.

Better performance due to repeated testing can bias long-term trajectories of cognitive aging and correlates of change. We examined whether retest effects differ as a function of individual differences pertinent to cognitive aging: race/ethnicity, age, sex, language, years of education, literacy, and dementia risk factors including apolipoprotein E ε4 status, baseline cognitive performance, and cardiovascular risk. We used data from the Washington Heights-Inwood Columbia Aging Project, a community-based cohort of older adults (n=4073). We modeled cognitive change and retest effects in summary factors for general cognitive performance, memory, executive functioning, and language using multilevel models. Retest effects were parameterized in two ways, as improvement between the first and subsequent testings, and as the square root of the number of prior testings. We evaluated whether the retest effect differed by individual characteristics. The mean retest effect for general cognitive performance was 0.60 standard deviations (95% confidence interval [0.46, 0.74]), and was similar for memory, executive functioning, and language. Retest effects were greater for participants in the lowest quartile of cognitive performance (many of whom met criteria for dementia based on a study algorithm), consistent with regression to the mean. Retest did not differ by other characteristics. Retest effects are large in this community-based sample, but do not vary by demographic or dementia-related characteristics. Differential retest effects may not limit the generalizability of inferences across different groups in longitudinal research.

Competitive Memory Training (COMET) for OCD: a self-treatment approach to obsessions.

Competitive Memory Training (COMET) is a cognitive intervention that aims to change the maladaptive cognitive-emotional networks underlying obsessive-compulsive disorder (OCD). COMET has not been previously tried as a self-help intervention. The present study tested the preliminary feasibility, acceptability, and effectiveness of COMET for OCD implemented as a self-help intervention. Sixty-five participants with OCD recruited through online OCD self-help fora completed an online baseline assessment including measures of OCD symptoms, self-esteem, and depression. Participants were randomly assigned to either COMET or a wait-list control group. All participants were approached 4 weeks later to complete an online post-assessment. There was no evidence for a greater decline of OCD symptoms or depression under COMET. When analyses were limited to only those participants who reported reading the entire manual at least once, self-esteem was higher at post-assessment in the COMET group. Although 78.1% of patients in the COMET group rated it as appropriate for self-administration, only 56.5% performed COMET exercises regularly and 26.4% read the entire manual at least once. The feasibility and effectiveness of COMET as a self-help internet intervention for OCD was not supported in this study. Further work is needed to better understand if modifications to our implementation of COMET may yield improved outcomes.

Change in negative mental filter is associated with depression reduction in metacognitive training for depression in older adults (MCT-Silver).

Identifying components of modularized psychological interventions that contribute to symptom reduction is essential to improving depression treatment. In a secondary analysis of a randomized controlled trial (RCT), session-specific effects of Metacognitive Training-Silver, a group intervention for older adults with depression, were investigated. Thirty-eight older adults with major depressive disorder or dysthymia participated in up to eight sessions of MCT-Silver. A clinical assessment of depressive symptoms (Hamilton Depression Rating Scale) as well as additional interviews and questionnaires administered as part of the RCT were completed at pre- and post-intervention. Depressive symptoms, negative (meta)cognitive beliefs, emotion regulation strategies and attitudes toward aging were assessed pre- and post-session. The rate of change in each variable per module, elevation following the module in which the variable was addressed, and the rate of change post module were examined via linear mixed models. Clinician-rated depressive symptoms were significantly reduced from pre- to post-intervention (Cohens d = 1.31). Self-reported depression and negative mental filter measured within sessions improved significantly over treatment, whereas black-and-white thinking improved after module #3 (Should Statements, All or Nothing Thinking and Acceptance). Module-specific within-session effects were found for overgeneralization (module #1: Mental Filter) and rumination (module #6: Rumination and Social Withdrawal). Improvement in mental filter in module #1 was significantly associated with depression reduction. This study provides initial evidence that MCT-Silver partially meets its aims of reducing depression and specific cognitive variables within and across sessions. Improvement of the instrument used to measure change may improve detection of module-specific effects.Trial registration: NCT03691402.

Psychotherapeutic interventions for depressive symptoms in older adults in a community setting: a systematic review protocol.

Depression is a prevalent illness among the elderly, so psychotherapeutic interventions are needed to promote health and quality of life. This literature review aims to identify trials of any psychotherapeutic interventions aimed at reducing depressive symptoms in older adults. A systematic literature review with a meta-analysis will be carried out. The following databases will be searched: CINAHL Plus with Full Text, MedicLatina, MEDLINE with Full Text, and Psychology and Behavioral Sciences Collection. To minimize bias, four reviewers will independently assess the inclusion of studies. The fifth reviewer will be responsible for disaggregating inclusion and exclusion between two authors. The results of the analysis will be grouped in a table with the characteristics of the included studies, including author, year, sample, objectives, methods, assessment instruments, psychotherapeutic interventions, results, follow-up and a data compilation scheme. This scientific article is a systematic review protocol for which the data has already been extracted and is being analyzed. Examples of possible strategies to include cognitive restructuring and mental health programs for older adults in community settings. With this clear and direct identification of psychotherapeutic interventions, it will be clearer for mental health professionals to be able to intervene effectively to promote the mental health and well-being of older adults. PROSPERO registration number: CRD42023449190.

Evaluation of the Psychometric Properties of the 18-Items Dysfunctional Attitudes Scale (Form B) in a Portuguese Sample of People Aged 60 and Over.

The aim of the study is to assess the psychometric properties of the Portuguese version of the 18-items Dysfunctional Attitudes Scale (Form B) in a Portuguese sample of people aged 60 and over. Background: The 18-item Dysfunctional Attitudes Scale (Form B) is an instrument for assessing dysfunctional attitudes and can be useful as a predictor of depression for both initial episodes and relapses Methods: This was a one-stage cross-sectional survey of Portuguese-speaking people aged 60 years and over, able to read and write, functionally autonomous, and living in the community in their usual residences. The instrument was evaluated for its psychometric properties. Convergent validity with the Beck Depression Inventory-II was assessed. Results: The Portuguese version of the 18-item Dysfunctional Attitudes Scale (Form B) was structured into three factors, which explained a total of 58.95% of the total variance of the instrument. The exploratory factor analysis resulted in a modified model in which three factors were obtained with an eigenvalue greater than one (Kaiser's criterion). Three factors were obtained instead of two as in the original study. It showed an internal consistency (Cronbach's alpha = 0.770) and an interclass correlation coefficient ranging from 0.166 to 0.449, and the overall convergent validity with the Beck Depression Inventory-II was considered good; Conclusions: The Portuguese version of the Dysfunctional Attitudes Scale (DAS-18B) of people aged 60 and over demonstrated good psychometric properties.

Assessment of Adult ADHD in Clinical Practice: Four Letters-40 Opinions.

Objective: Despite guidelines providing detailed recommendations for the assessment of ADHD in adults and increasing clinician awareness of the persistence of ADHD into adulthood, ADHD remains under diagnosed in many countries. Method: A survey of 178 clinicians who regularly perform assessments for adult ADHD was conducted between February 2015 and 2016 to identify possible causes of underdiagnosis related to assessment practices. Results: There was a lack of consensus among clinicians regarding which symptoms are relevant to adult ADHD. Only "difficulties concentrating" was endorsed as a core feature of adult ADHD by a majority of respondents. Few clinicians used (semi-)structured interviews. Psychologists were less likely than physicians to recommend medication. Conclusion: Further clinician training on core symptoms of adult ADHD and diagnostic practices congruent with guideline recommendations may improve symptom recognition among clinicians and diagnostic accuracy. Identification of barriers to the implementation of diagnostic practices recommended by guidelines is needed.

In the eyes of the beholders: Subjective experiences of positive symptoms among patients with symptoms of psychosis seeking psychotherapy.

BACKGROUND: Reduction of positive symptoms is often the focus of psychiatric treatment for patients with psychosis; however, it is becoming increasingly clear that some patients experience ambivalence towards positive symptoms or may even experience them as pleasant. The present study extends upon work from online studies of patients without verified diagnoses. The first aim was to examine the frequency with which patients report negative, neutral or even positive appraisals of positive symptoms. A second aim was to identify whether these appraisals were associated with medication adherence. METHODS: One-hundred twelve treatment-seeking patients with current symptoms of psychosis completed the Subjective Perception of Positive Symptoms-Revised (SUPPOSY-R), a scale assessing appraisals of positive symptoms (e.g., gain from illness, impact on daily life), as well as questions regarding medication adherence. RESULTS: Although most patients reported experiencing positive symptoms as predominantly unpleasant, appraisals differed between symptom clusters and up to 54.4 % reported that they would miss at least some aspects of positive symptoms should they disappear. Patients particularly welcomed the disappearance of auditory hallucinations (71.2 %). Symptom appraisal was not significantly associated with medication compliance (p > .17); however, more patients with low medication adherence reported they would feel at least some regret if their symptoms were to completely disappear (48.9 %, n = 23) versus patients with high adherence (41.7 %, n = 20). DISCUSSION: Ambivalent or positive appraisals of positive symptoms are lower among treatment-seeking patients compared to patients recruited for online studies, who may not be actively seeking treatment. Auditory hallucinations may cause most distress among treatment-seeking patients. A collaborative approach including assessment of possible positive appraisals of symptoms is important when identifying treatment goals.

A randomized controlled trial to evaluate the efficacy of metacognitive training for older adults with depression (MCT-Silver) in Portugal: study protocol.

Introduction: Depression is one of the most common psychological disorders in later life. Although psychological interventions are recommended by treatment guidelines, most older adults with depression remain untreated. The aim of this study is to evaluate the efficacy of the Portuguese version of Metacognitive Training for Depression in later life (MCT-Silver). Methods: This is a study protocol of an observer-blind, parallel-group, randomized controlled trial to compare the efficacy of MCT-Silver with a treatment as usual (TAU) control group among older adults (age 65 years and older) with depressive symptoms according to the Montgomery-Asberg Depression Scale. Participants will be tested at three assessment time points (baseline, immediately following the intervention [8 weeks], and 3 months after the intervention). The primary outcome is change in self-rated depression symptoms assessed by the Beck Depression Inventory (BDI-II). Secondary outcomes include clinician-rated depression, self-esteem, dysfunctional beliefs, metacognitive beliefs, ruminations, attitudes toward aging and quality of life. A self-designed subjective appraisal rating scale consisting of 21-items will be used to assess participant acceptance of MCT-Silver. Discussion: MCT-Silver is an innovative intervention, which aims to reduce dysfunctional thoughts as well as depression-related behaviors and coping strategies through the metacognitive perspective. Until now, the training has only been tested in Germany. It is expected that after 8 weeks of treatment and 3 months later, the experimental group will demonstrate significant reductions in depressive symptoms, metacognitive beliefs, dysfunctional attitudes and ruminative responses compared to the TAU group. Moreover, quality of life, self-esteem, and attitudes towards aging will be significantly improved in MCT-Silver compared to the TAU group. Clinical trial registration: ClinicalTrials.gov, NCT05640492.

Depression in older adults during the COVID-19 pandemic: A systematic review.

BACKGROUND: Depression affected 5.7% of people aged 60 years and over prior to the pandemic and has increased by approximately 28%. The aim of this study is to identify and describe factors associated with depressive symptoms, the diagnostic assessment instruments and interventions used to evaluate and treat depression in adults aged 60 years and older since the onset of the COVID-19 pandemic. METHODS: Four electronic databases were systematically searched to identify eligible studies published since the beginning of the COVID-19 pandemic. A total of 832 articles were screened, of which 53 met the inclusion criteria. RESULTS: Factors contributing to depressive symptoms in older adults prior to the pandemic were grouped into the following categories: sociodemographic characteristics (i.e., being female); loneliness and weak social support; limitations in daily functioning, physical activity and neurocognitive impairment; and clinical factors. The following groups of factors directly related to the pandemic were found: stress-related factors and feelings or worries related to the pandemic; information access (e.g., receiving news about COVID-19 through the media); factors directly related to COVID-19 (e.g., having infected acquaintances); and factors related to the measures that were taken to reduce the spread of COVID-19 (e.g., confinement measures). The most frequently used instrument to assess depressive symptoms was the Geriatric Depression Scale Short Form (GDS-SF). Four studies implemented interventions during the pandemic that led to significant reductions in depressive symptoms and feelings of loneliness. CONCLUSIONS: Improved understanding of pandemic-associated risk factors for depression can inform person-cantered care. It is important continued mental healthcare for depression for older adults throughout crises, such as the COVID-19 pandemic. Remote delivery of mental healthcare represents an important alternative during such times. It is crucial to address depression in older adults (which often causes disability), since the pandemic situation has increased depressive symptoms in this population.

Negative cognitive beliefs, positive metacognitive beliefs, and rumination as mediators of metacognitive training for depression in older adults (MCT-Silver).

Background: Metacognitive Training for Depression in older adults (MCT-Silver; www.uke.de/mct-silver) is a cognitive-behavioral based group intervention that aims at reducing depression by targeting (meta)cognitive beliefs and rumination. In the present study, it was examined whether negative cognitive beliefs, positive metacognitive beliefs and/or rumination may be implicated as mediators of MCT-Silver's effects on depression. Materials and methods: We conducted a secondary analysis of a randomized controlled trial comparing MCT-Silver to an active control intervention (cognitive remediation) including 66 older adults (60 years and older) with complete baseline data. Clinician-rated (Hamilton Depression Rating Scale) and self-reported (Beck Depression Inventory-II) depression, negative cognitive beliefs (Dysfunctional Attitudes Scale-18B), positive metacognitive beliefs (positive beliefs subscale; Metacognition Questionnaire-30) and rumination (10-item Ruminative Response Scale) were assessed before (pre) and after 8 weeks of treatment (post), as well as 3 months later (follow-up). It was examined whether change in depression (pre- to follow-up) was mediated by change in negative cognitive beliefs, positive metacognitive beliefs and/or rumination (pre- to post-assessment). Results: Mediation results differed for self-reported vs. clinician-rated depression. The effect of MCT-Silver on reduction in clinician-rated depression was mediated by a reduction in self-reported rumination, whereas reduction in self-reported depression was mediated by a reduction in negative cognitive beliefs. Positive metacognitive beliefs were not a significant mediator for either outcome. Conclusion: The current study provides initial evidence for the roles of negative cognitive beliefs and rumination in the treatment of depression in later life with MCT-Silver. Given the divergence of findings and lack of causal precedence, mechanisms of change for MCT-Silver cannot yet be equivocally identified.

Remission with or without comorbid substance use disorders in early psychosis: long-term outcome in integrated care (ACCESS III study).

Introduction: Schizophrenia-Spectrum-Disorders are associated with poor long-term outcome as well as disability and often severely affect the lives of patients and their families often from symptom onset. Up to 70% of first episode psychosis (FEP) patients suffer from comorbid substance use disorders (SUD). We aimed at studying the course of illness in FEP patients within evidence-based care, with and without comorbid SUD, to examine how decreased, remitted or persistent substance use impacted rates of a combined symptomatic and functional long-term recovery compared with patients without SUD. Methods: ACCESS III is an integrated care model for FEP or patients in the early phase of non-affective and affective psychotic disorders. Treatment trajectories of patients, who had been in ACCESS care for 1 year, with and without SUD were compared with regard to the course of illness and quality of life using Mixed Model Repeated Measures (MMRM) and recovery rates were compared using binary logistic regression. Change in substance use was coded as either persistent, decreased/remitted or no use. Results: ACCESS III was a prospective 1-year study (N = 120) in patients aged 12-29 years. Of these, 74 (61.6%) had a comorbid SUD at admission. There were no group differences regarding the course of illness between patients with or without comorbid SUD or between patients with a substance abuse or substance dependence. The only outcome parameter that was affected by SUD was quality of life, with larger improvement found in the group without substance use (p = 0.05) compared to persistent and remitted users. Using LOCF, 44 patients (48.9%) fulfilled recovery criteria at the endpoint; recovery did not differ based on substance use status. Discussion: SUD and especially substance dependence are common in psychotic disorders even in FEP patients. Evidence-based integrated care led to long-term improvement in patients with comorbid SUD and rate of recovery did not differ for patients with substance use.

Vascular burden and cognitive functioning in depressed older adults.

BACKGROUND: Vascular burden is known to contribute to geriatric depression and cognitive impairment. The objective of our study was to evaluate the relationship between vascular burden and pattern of cognitive impairment in older adults with depression. METHODS: Ninety-four community-dwelling older adults (mean age = 70.8 years; SD = 7.63) diagnosed with major depression were recruited to participate in the tai chi complementary use study aimed to improve antidepressant response to an antidepressant medication. All participants received comprehensive evaluations of depression, apathy, and vascular risk factors, and completed a battery of cognitive measures of memory, cognitive control, verbal fluency, and attention. RESULTS: The severity of vascular burden was significantly correlated with depression severity and impaired performance on measures of cognitive control (i.e., inhibition/mental flexibility), and attention, but not memory or verbal fluency. Neither the severity of comorbid apathy nor medical illness burden was related to cognitive impairment. CONCLUSIONS: Vascular burden in older depressed adults contributes to cognitive impairment, particularly in domains of attention and cognitive control. Our findings suggest that aggressive treatment of vascular risk factors may reduce risk for further cognitive decline in depressed older adults.

Accuracy, interpretability and usability study of a wireless self-guided fetal heartbeat monitor compared to cardiotocography.

Fetal Cardiography is usually performed using in-hospital Cardiotocographic (CTG) devices to assess fetal wellbeing. New technologies may permit home-based, self-administered examinations. We compared the accuracy, clinical interpretability, and user experience of a patient-administered, wireless, fetal heartbeat monitor (HBM) designed for home use, to CTG. Initially, participants had paired HBM and CTG examinations performed in the clinic. Women then used the HBM unsupervised and rated the experience. Sixty-three women had paired clinic-based HBM and CTG recordings, providing 6982 fetal heart rate measures for point-to-point comparison from 126 min of continuous recording. The accuracy of the HBM was excellent, with limits of agreement (95%) for mean fetal heart rate (FHR) between 0.72 and -1.78 beats per minute. The FHR was detected on all occasions and confirmed to be different from the maternal heart rate. Both methods were equally interpretable by Obstetricians, and had similar signal loss ratios. Thirty-four (100%) women successfully detected the FHR and obtained clinically useful cardiographic data using the device at home unsupervised. They achieved the required length of recording required for non-stress test analysis. The monitor ranked in the 96-100th percentile for usability and learnability. The HBM is as accurate as gold-standard CTG, and provides equivalent clinical information enabling use in non-stress test analyses conducted outside of hospitals. It is usable by expectant mothers with minimal training.

Depression in older adults during the COVID-19 pandemic: a systematic review protocol.

INTRODUCTION: Depression is a common mental disorder and is a major cause of years lived with disability. The COVID-19 pandemic has caused an increase in the prevalence of depression worldwide. Our aim is to identify and synthesise the determinants of depression, the diagnostic assessment tools used to evaluate depression, and the interventions carried out since the beginning of the COVID-19 pandemic in the population aged 60 and older. METHODS AND ANALYSIS: A systematic review of the literature will be conducted. The following databases will be searched: CINAHL Plus with Full Text, MedicLatina, MEDLINE with Full Text, and Psychology and Behavioural Sciences Collection. The search strategy will include the following Medical Subject Headings or similar terms: "Depression", "Depressive Disorder", "Depressive Symptoms", "Older Adults", "Aging", "Elderly", Pandemic" and "COVID-19". Two independent reviewers will ascertain whether the resulting articles meet inclusion and exclusion criteria, and perform the analysis of data quality. Disagreements will be resolved by a third reviewer. All studies reported between December 2019 and March 2022 meeting the following criteria will be included: studies in adults aged 60 and over, and articles written in English, Portuguese, Spanish or German. Information on determinants of depression, assessment instruments used to assess depressive symptoms and/or interventions to decrease depression are reported. Studies will not be excluded based on geographical area study context (eg, community, culture or specific environment). All studies related to diagnostic assessment, care planning and/or intervention strategies specifically for older adults with depression will be included. ETHICS AND DISSEMINATION: As only secondary data will be analysed, no ethical approval is required for this study. This scientific article is a systematic review protocol for which data have not yet been extracted or analysed. The results will be disseminated through peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42022299775.

Effect of a DVD intervention on therapists' mental health practices with older adults.

PURPOSE: We tested the effectiveness of an educational intervention in DVD format aimed at strengthening the mental health practices of occupational therapists working with older adults. METHOD: The DVD intervention was tested in a pretest-posttest design. Occupational therapists (n = 30) completed a brief knowledge and attitude questionnaire; a chart review (n = 383) of therapists' (n = 20) patients at 3 mo before and 3 mo after DVD training was also conducted. RESULTS: Questionnaire data showed that the percentage of therapists with correct answers increased 20%-30% for 5 of the 11 knowledge items. Chart review data showed therapists spoke more often with their older patients about mood, depression, and cognitive impairment; screened more often for depression and cognitive impairment; and reported findings more often to the treatment team after training. CONCLUSION: Educational interventions can significantly improve therapists' mental health practice with older adults.

Accuracy, Clinical Utility, and Usability of a Wireless Self-Guided Fetal Heart Rate Monitor.

OBJECTIVE: To evaluate the accuracy, clinical utility, and usability of a wireless fetal and maternal heartbeat monitor to monitor fetal heart rate (FHR). METHODS: We conducted a prospective, single-center study of a convenience sample of women aged 18 years or older with a singleton pregnancy of at least 12 weeks of gestation. Fetal heart rate recordings were performed using both the heartbeat monitor and cardiotocography to evaluate accuracy. Clinicians used the heartbeat monitor in the clinic. Women used the device, unassisted, during a clinic visit or at home. Obstetricians assessed the clinical utility of FHR traces. Women rated the heartbeat monitor using the System Usability Scale. RESULTS: A total of 81 participants provided 126 recordings. The accuracy of the heartbeat monitor was excellent compared with cardiotocography, with limits of agreement (95%) for mean FHR between -1.6 (CI -2.0 to 1.3) and +1.0 (CI 0.7-1.4) beats per minute (bpm), mean difference -0.3 bpm, intraclass coefficient 0.99. The FHR was detected on all occasions. Clinicians took a median (interquartile range) of 0.5 (0.2-1.2) minutes to detect the FHR, obtaining a continuous trace of longer than 1 minute in 95% (39/41) of occasions. Home users took a median of 0.5 (0.2-2.0) minutes to detect the FHR, obtaining a continuous trace of longer than 1 minute in 92% (24/26) of occasions, with a median total trace time of 4.6 (4.4-4.8) minutes. The traces were deemed clinically useful in 100% (55/55) of clinician and 97% (31/32) of home recordings. The heartbeat monitor ranked in the 96-100th percentile for usability and learnability. CONCLUSION: The heartbeat monitor was accurate and easy for clinicians and participants to use. Data recorded at home were equivalent to those obtained using current assessment protocols for low-risk pregnancies, potentially allowing the device to be used in telehealth consultations. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12620000739910. FUNDING SOURCES: The HeraBEAT devices used in this study were loaned by HeraMED Pty Ltd (HeraMED, Netanya, ISRAEL). The study was supported by PHI Research Group (not-for-profit), which was responsible for Statistician fees and Research Assistants' salaries. Joondalup Health Campus provided infrastructure support, and IT services in-kind to the PHI research group.