Effects of a Self-Guided Transdiagnostic Smartphone App on Patient Empowerment and Mental Health: Randomized Controlled Trial

Background: Mental disorders impact both individuals and health systems. Symptoms and syndromes often remain undetected and untreated, resulting in chronification. Besides limited health care resources, within-person barriers such as the lack of trust in professionals, the fear of stigmatization, or the desire to cope with problems without professional help contribute to the treatment gap. Self-guided mental health apps may support treatment seeking by reducing within-person barriers and facilitating mental health literacy. Digital mental health interventions may also improve mental health related self-management skills and contribute to symptom reduction and the improvement of quality of life. Objective: This study aims to investigate the effects of a self-guided transdiagnostic app for mental health on help seeking, reduced stigma, mental health literacy, self-management skills, mental health symptoms, and quality of life using a randomized controlled design. Methods: Overall, 1045 participants (recruited via open, blinded, and web-based recruitment) with mild to moderate depression or anxiety-, sleep-, eating-, or somatization-related psychopathology were randomized to receive either access to a self-guided transdiagnostic mental health app (MindDoc) in addition to care as usual or care as usual only. The core features of the app were regular self-monitoring, automated feedback, and psychological courses and exercises. The coprimary outcomes were mental health literacy, mental health–related patient empowerment and self-management skills (MHPSS), attitudes toward help seeking, and actual mental health service use. The secondary outcomes were psychopathological symptom burden and quality of life. Data were collected at baseline and 8 weeks and 6 months after randomization. Treatment effects were investigated using analyses of covariance, including baseline variables as predictors and applying multiple imputation. Results: We found small but robust between-group effects for MHPSS (Cohen d=0.29), symptoms burden (Cohen d=0.28), and quality of life (Cohen d=0.19) 8 weeks after randomization. The effects on MHPSS were maintained at follow-up. Follow-up assessments also showed robust effects on mental health literacy and preliminary evidence for the improvement of help seeking. Predictors of attrition were lower age and higher personality dysfunction. Among the non-attritors, predictors for deterioration were less outpatient treatment and higher initial symptom severity. Conclusions: A self-guided transdiagnostic mental health app can contribute to lasting improvements in patient empowerment. Symptoms of common mental disorders and quality of life improved faster in the intervention group than in the control group. Therefore, such interventions may support individuals with symptoms of 1 or more internalizing disorders, develop health-centered coping skills, prevent chronification, and accelerate symptom improvement. Although the effects for individual users are small and predictors of attrition and deterioration need to be investigated further, the potential public health impact of a self-guided intervention can be large, given its high scalability. Trial Registration: German Clinical Trials Register DRKS00022531; https://drks.de/search/de/trial/DRKS00022531 JMIR Ment Health 2023;10:e4506

Improving Mild to Moderate Depression With an App-Based Self-Guided Intervention: Protocol for a Randomized Controlled Trial

Background: Depression is one of the most prevalent mental disorders and frequently co-occurs with other mental disorders. Despite the high direct and indirect costs to both individuals and society, more than 80% of those diagnosed with depression remain with their primary care physician and do not receive specialized treatment. Self-guided digital interventions have been shown to improve depression and, due to their scalability, have a large potential public health impact. Current digital interventions often focus on specific disorders, while recent research suggests that transdiagnostic approaches are more suitable. Objective: This paper presents the protocol for a study that aims to assess the efficacy of a self-guided transdiagnostic app-based self-management intervention in patients with mild or moderate depression with and without comorbid mental disorders. Specifically, we are investigating the impact of the intervention on symptoms of depression, quality of life, anxiety symptoms, and mental health–related patient empowerment and self-management skills. Methods: The intervention under investigation, MindDoc with Prescription, is a self-guided digital intervention aimed at supporting individuals with mild to moderate mental disorders from the internalizing spectrum, including depression. The app can be used as a low-threshold psychosocial intervention. Up to 570 adult patients will be randomized to either receive the intervention in addition to care as usual or only care as usual. We are including adults with a permanent residency in Germany and mild or moderate depression according to International Classification of Diseases, 10th Revision, criteria (F32.0, F32.1, F33.0, and F33.1). Clinical interviews will be conducted to confirm the diagnosis. Data will be collected at baseline as well as 8 weeks and 6 months after randomization. The primary outcome will be depression symptom severity after 8 weeks. Secondary outcomes will be quality of life, anxiety symptom severity, and patient empowerment and self-management behaviors. Data will be analyzed using multiple imputations, using the intention-to-treat principle, while sensitivity analyses will be based on additional imputation strategies and a per-protocol analysis. Results: Recruitment for the trial started on February 7, 2023, and the first participant was randomized on February 14, 2023. As of September 5, 2023, 275 participants have been included in the trial and 176 have provided the primary outcome. The rate of missing values in the primary outcome is approximately 20%. Conclusions: Data from this efficacy trial will be used to establish whether access to the intervention is associated with an improvement in depression symptoms in individuals diagnosed with mild or moderate depression. The study will contribute to expanding the evidence base on transdiagnostic digital interventions. Trial Registration: German Registry of Clinical Trials DRKS00030852; https://drks.de/search/de/trial/DRKS0003085

Pelvic organ movements in asymptomatic nulliparous and symptomatic premenopausal women with pelvic organ prolapse in dynamic MRI: a feasibility study comparing midsagittal single-slice with multi-slice sequences

PURPOSE To compare multi-slice (MS) MRI sequences of the pelvis acquired at rest and straining to dynamic midsagittal single-slice (SS) sequences for the assessment of pelvic organ prolapse (POP). METHODS This IRB-approved prospective single-center feasibility study included 23 premenopausal symptomatic patients with POP and 22 asymptomatic nulliparous volunteers. MRI of the pelvis at rest and straining was performed with midsagittal SS and MS sequences. Straining effort, visibility of organs and POP grade were scored on both. Organ points (bladder, cervix, anorectum) were measured. Differences between SS and MS sequences were compared with Wilcoxon test. RESULTS Straining effort was good in 84.4% on SS and in 64.4% on MS sequences (p = 0.003). Organ points were always visible on MS sequences, whereas the cervix was not fully visible in 31.1-33.3% on SS sequences. At rest, there were no statistically significant differences of organ point measurements between SS and MS sequences in symptomatic patients. At straining, positions of bladder, cervix, and anorectum were + 1.1 cm (± 1.8 cm), - 0.7 cm (± 2.9 cm), and + 0.7 cm (± 1.3 cm) on SS and + 0.4 mm (± 1.7 cm), - 1.4 cm (± 2.6 cm), and + 0.4 cm (± 1.3 cm) on MS sequences (p < 0.05). Only 2 cases of higher-grade POP were missed on MS sequences (both with poor straining effort). CONCLUSION MS sequences increase the visibility of organ points compared to SS sequences. Dynamic MS sequences can depict POP if images are acquired with sufficient straining effort. Further work is needed to optimize the depiction of the maximum straining effort with MS sequences

Assessment of pelvic organ prolapse with the Pelvic Inclination Correction System: defining the normal range and threshold to pathology.

PURPOSE To define the normal range and threshold values for pathologic prolapse on MRI using the PICS line and assess its correlation with the pubococcygeal line (PCL). METHODS This prospective, IRB-approved study included 20 nulliparous volunteers and 18 prolapse patients (POP-Q Stage ≥ 2). Organ positions (bladder, cervix, anorectal junction) relative to PICS and PCL were measured on dynamic MRI. Differences in organ position were compared. Receiver-operating characteristic (ROC) analysis was performed to identify cutoff values for prolapse using the PICS line. The correlation between PICS and PCL measurements was tested with Spearman's rank correlation. RESULTS In volunteers, median bladder and cervix positions measured to the PICS at rest were - 2.7 cm and - 5.3 cm compared to - 1.9 cm and - 2.7 cm in patients (p < 0.001). During straining, bladder and cervix were at - 0.9 cm and - 3.2 cm in volunteers versus + 2.5 cm and + 2.5 cm in patients (p < 0.001). Correlation was strong for PICS and PCL measurements for all three compartments (δ = 0.883-0.970, p ≤ 0.001). AUCs of PICS for the anterior and middle compartment were 0.98 (95% confidence interval [CI] 0.96-1.00, p < 0.001) and 0.96 (95% CI 0.89-1.00, p < 0.001) for differentiating patients from healthy volunteers. AUC for the posterior compartment was 0.76 (95% CI 0.57-0.96, p = 0.034). CONCLUSION PICS measurements reliably differentiate patients from volunteers in the anterior and middle compartment. Future studies need to identify a reliable threshold for the posterior compartment. PICS and PCL measurements are strongly correlated

Prediction of pelvic lymph node metastases and PSMA PET positive pelvic lymph nodes with multiparametric MRI and clinical information in primary staging of prostate cancer

PURPOSE To compare the accuracy of multiparametric MRI (mpMRI), $^{68}$Ga-PSMA PET and the Briganti 2019 nomogram in the prediction of metastatic pelvic lymph nodes (PLN) in prostate cancer, to assess the accuracy of mpMRI and the Briganti nomogram in prediction of PET positive PLN and to investigate the added value of quantitative mpMRI parameters to the Briganti nomogram. METHOD This retrospective IRB-approved study included 41 patients with prostate cancer undergoing mpMRI and $^{68}$Ga-PSMA PET/CT or MR prior to prostatectomy and pelvic lymph node dissection. A board-certified radiologist assessed the index lesion on diffusion-weighted (Apparent Diffusion Coefficient, ADC; mean/volume), T2-weighted (capsular contact length, lesion volume/maximal diameters) and contrast-enhanced (iAUC, k$_{ep}$, K$^{trans}$, v$_{e}$) sequences. The probability for metastatic pelvic lymph nodes was calculated using the Briganti 2019 nomogram. PET examinations were evaluated by two board-certified nuclear medicine physicians. RESULTS The Briganti 2019 nomogram performed superiorly (AUC: 0.89) compared to quantitative mpMRI parameters (AUCs: 0.47-0.73) and $^{68}$Ga-PSMA-11 PET (AUC: 0.82) in the prediction of PLN metastases and superiorly (AUC: 0.77) in the prediction of PSMA PET positive PLN compared to MRI parameters (AUCs: 0.49-0.73). The addition of mean ADC and ADC volume from mpMRI improved the Briganti model by a fraction of new information of 0.21. CONCLUSIONS The Briganti 2019 nomogram performed superiorly in the prediction of metastatic and PSMA PET positive PLN, but the addition of parameters from mpMRI can further improve its accuracy. The combined model could be used to stratify patients requiring ePLND or PSMA PET

A web-based intervention for carers of individuals with anorexia nervosa (We Can): trial protocol of a randomised controlled trial investigating the effectiveness of different levels of support

Background Anorexia nervosa (AN) is a life-threatening mental disorder that is associated with substantial caregiver burden. Carers of individuals with AN report high levels of distress and self-blame, and insufficient knowledge to help their loved ones. However, carers can have a very important role to play in aiding recovery from AN, and are often highly motivated to assist in the treatment process. This manuscript presents the protocol for a randomised controlled trial (RCT) of We Can, a web-based intervention for carers for people with AN. The study aims to investigate the effectiveness of We Can delivered with different intensities of support. Methods The study takes the form of a multi-site, two-country, three group RCT, comparing We Can (a) with clinician messaging support (We Can-Ind), (b) with moderated carer chatroom support (We Can-Chat) and (c) with online forum only (We Can-Forum). Participants will be 303 carers of individuals with AN as well as, where possible, the individuals with AN themselves. Recruitment will be via specialist eating disorder services and carer support services in the UK and Germany. Randomisation of carers to one of the three intervention conditions in a 1:1:1 ratio will be stratified by whether or not the individual with AN has (a) agreed to participate in the study and (b) is a current inpatient. The We Can intervention will be provided to carers online over a period of 12 weeks. Participants will complete self-report questionnaires at pre-intervention (T1), mid-intervention (mediators only; 4-weeks post-randomisation), post-intervention (T2; 3-months post randomisation), and 6 months (T3) and 12 months (T4) after randomisation. The primary outcome variables are carer symptoms of depression and anxiety. Secondary outcome variables will be measured in both carers and individuals with AN. Secondary carer outcome variables will include alcohol and drug use and quality of life, caregiving behaviour, and the acceptability and use of We Can and associated supports. Secondary outcomes measured in individuals with AN will include eating disorder symptoms, and symptoms of depression and anxiety. The study will also evaluate the cost-effectiveness of the three We Can conditions, and test for mediators and moderators of the effects of We Can. The trial is registered at the International Standard Randomisation Controlled Trial Number (ISRCTN) database, registration number: ISRCTN11399850. Discussion The study will provide insight into the effectiveness of We Can and its optimal method/s of delivery

Interrelations between participant and intervention characteristics, process variables and outcomes in online interventions: A protocol for overarching analyses within and across seven clinical trials in ICare

Background: It is well known that web-based interventions can be effective treatments for various conditions. Less is known about predictors, moderators, and mediators of outcome and especially interrelations between participant and interventions characteristics, process variables and outcomes in online interventions. Clinical trials often lack statistical power to detect variables that affect intervention effects and their interrelations. Within ICare, we can investigate the interrelation of potential predictor and process variables in a large sample. Method: The ICare consortium postulated a model of interrelations between participant and intervention characteristics, process variables and outcomes in online interventions. We will assess general and disorderspecific interrelations between characteristics of the intervention, characteristics of the participants, adherence, working alliance, early response, and intervention outcomes in a sample of over 7500 participants from seven clinical trials evaluating 15 online interventions addressing a range of mental health conditions and disorders, using an individual participant data meta-analyses approach. Discussion/conclusion: Existing research tends to support the efficacy of online mental health interventions, but the knowledge base regarding factors that affect intervention effects needs to be expanded. The overarching analyses using data from the ICare intervention trials will add considerably to the evidence

Preliminary evaluation of the engagement and effectiveness of a mental health chatbot

Background: Mental health difficulties are highly prevalent, yet access to support is limited by barriers of stigma, cost, and availability. These issues are even more prevalent in low- and middle-income countries, and digital technology is one potential way to overcome these barriers. Digital mental health interventions are effective but often struggle with low engagement rates, particularly in the absence of human support. Chatbots could offer a scalable solution, simulating human support at a lower cost. Objective: To complete a preliminary evaluation of engagement and effectiveness of Vitalk, a mental health chatbot, at reducing anxiety, depression and stress. Methods: Real world data was analyzed from 3,629 Vitalk users who had completed the first phase of a Vitalk program (“less anxiety,” “less stress” or “better mood”). Programs were delivered through written conversation with a chatbot. Engagement was calculated from the number of responses sent to the chatbot divided by days in the program. Results: Users sent an average of 8.17 responses per day. For all three programs, target outcome scores reduced between baseline and follow up with large effect sizes for anxiety (Cohen's d = −0.85), depression (Cohen's d = −0.91) and stress (Cohen's d = −0.81). Increased engagement resulted in improved post-intervention values for anxiety and depression. Conclusion: This study highlights a chatbot's potential to reduce mental health symptoms in the general population within Brazil. While findings show promise, further research is required

Assessing the costs and cost-effectiveness of ICare internet-based interventions (protocol)

Background: Mental health problems are common and place a burden on the individual as well as on societal resources. Despite the existence of evidence-based treatments, access to treatment is often prevented or delayed due to insufficient health care resources. Effective internet-based self-help interventions have the potential to reduce the risk for mental health problems, to successfully bridge waiting time for face-to-face treatment and to address inequities in access. However, little is known about the cost-effectiveness of such interventions. This paper describes the study protocol for the economic evaluation of the studies that form the ICare programme of internet-based interventions for the prevention and treatment of a range of mental health problems. Methods: An overarching work package within the ICare programme was developed to assess the cost-effectiveness of the internet-based interventions alongside the clinical trials. There are two underlying tasks in the ICare economic evaluation. First, to develop schedules that generate equivalent and comparable information on use of services and supports across seven countries taking part in clinical trials of different interventions and second, to estimate unit costs for each service and support used. From these data the cost per person will be estimated by multiplying each participant's use of each service by the unit cost for that service, taking both a public sector and a societal perspective. This individual level of cost data matches the level of outcome data used in the clinical trials. Following the analyses of service use and costs data, joint analysis of costs and outcomes will be undertaken to provide findings on the relative cost-effectiveness of the interventions. These analyses use a well-established framework, the Production of Welfare approach, and standard methods and techniques underpinned by economic theory. Discussion/conclusion: Existing research tends to support the effectiveness of internet-based interventions, but there is little information on their cost-effectiveness compared to ‘treatment as usual’. The economic evaluation of ICare interventions will add considerably to this evidence base

Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial

Background Guided self-help is a recommended first-step treatment for bulimia nervosa, binge eating disorder and atypical variants of these disorders. Further research is needed to compare guided self-help that is delivered face-to-face versus via email. Methods/Design This clinical trial uses a randomised, controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail, also using a delayed treatment control condition. At least 17 individuals are required per group, giving a minimum N of 51. Discussion Symptom outcomes will be assessed and estimates of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision. The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT01832792 on 9 April 2013