Background People with multiple sclerosis (pwMS) often experience impaired quality of life (QoL) despite receiving standard care. Digital therapeutics (DTx) may offer support, but prior trials yielded mixed results, possibly due to active controls and high baseline QoL. Objectives We evaluated a DTx (levidex) as an adjunct to treatment as usual (TAU) in pwMS with impaired QoL. Methods In this pragmatic, online randomized controlled trial (LAMONT; NCT06090305), n = 470 pwMS with a score ≥ 2 on the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) were randomized to levidex + TAU or TAU alone. The primary endpoint was HAQUAMS total score at 6 months, analysed by intention-to-treat analysis of covariance. Results Compared with TAU, levidex + TAU improved multiple sclerosis-specific QoL at 6 months (baseline-adjusted mean difference −0.10; 95% CI −0.18 to −0.03; p = 0.008; Cohen's d = 0.26). Clinically relevant HAQUAMS improvement (≥0.22) occurred more often with levidex (39.5% vs. 27.8%; number needed to treat = 9). Benefits also emerged for depressive symptoms and social/work functioning but not for anxiety. No serious adverse events occurred, and user satisfaction was high. Conclusions In pwMS with impaired QoL, adding the scalable DTx levidex to TAU yields meaningful improvements in QoL and functioning.

BACKGROUND:Hypertension is a major public health problem. Despite existing treatment options, overall blood pressure control is still insufficient. Digital health interventions have the potential to improve treatment success. We developed liebria, an internet-based digital intervention accessible via smartphones and computers, designed to support the self-management of hypertension. METHODS:We tested the effectiveness of liebria in reducing systolic blood pressure and improving other relevant endpoints in adults with hypertension using a parallel randomized controlled trial design. Adults with hypertension (mean age 54.5 years, 47.1% male) were recruited via a German health insurance provider and randomized (1:1; concealed allocation; no blinding of participants) to receive liebria in addition to treatment as usual (n = 52), or treatment as usual alone (n=50). Primary outcome was systolic blood pressure after 3 months (T1). Secondary endpoints were diastolic blood pressure, pulse pressure, quality of life, medication adherence, and social and work-related functioning. RESULTS:The study's statistical power was limited due to a smaller sample size (N = 102) than the a priori target sample size (N=676). Intention-to-treat analyses showed an effect of liebria on systolic blood pressure (baseline-adjusted between-group difference -3.5 mmHg, 95% CI -7.13 to 0.13, p = .053, Cohen's d = 0.36). More participants in the intervention group (78.2% vs. 54.3% in the control group) showed reductions in systolic blood pressure (p = .076). Moreover, liebria had effects on social and work-related functioning. No effects emerged for diastolic blood pressure, pulse pressure, quality of life, or medication adherence. No adverse events or device effects were observed. CONCLUSIONS:The present study shows first promising results of liebria's effects on systolic blood pressure and social and work-related functioning. Future studies should aim to replicate effects in a larger sample to increase statistical power. TRIAL REGISTRATION:German Clinical Trials Register (DRKS00025871); https://drks.de/search/en/trial/DRKS00025871 ; date of registration: October 5, 2021.

BACKGROUND:Fatigue is common in multiple sclerosis (MS); it significantly impairs quality of life, and treatment options are limited. A randomized controlled trial of Elevida, a self-guided, online German fatigue intervention, showed significant benefit. We tested an English version of Elevida with people with MS in Australia. METHODS:Participants were volunteers with MS who self-reported at least mild fatigue (≥ 43 on the Fatigue Scale for Motor and Cognitive Functions scale), some mobility (Expanded Disability Status Scale < 8), and no or mild cognitive difficulties (≤ 32 on the Multiple Sclerosis Neuropsychological Questionnaire). Participants completed the 9-week English Elevida program, commenting on and rating its acceptability. The Chalder Fatigue Scale was completed at baseline, end-of-program, and 2 months later. We undertook qualitative (thematic analysis) and quantitative (before/after differences, tested using paired t test) analyses. RESULTS:Thirty-eight people with MS expressed an interest in the study; 26 were eligible; 20 began the study. Fifteen participants (75%) completed the program (mean [SD]: 58.9 [10.5] years of age, 67% women, 9 with relapsing MS, 6 with progressive MS). Over 90% of completing participants rated acceptability as good or very good, and approximately 70% found the program helpful. Three themes were identified: Positive or negative comments on program features, incorrect assumptions in program content, and personal experiences and reflections. Significant improvement (P < .01) in fatigue scores from baseline to program completion was maintained 2 months after program completion. CONCLUSIONS:Elevida was acceptable and effective for MS-related fatigue. Identified themes will guide further development of the program to satisfy users' sense of autonomy, competence, and relatedness.

Abstract Background Multiple Sclerosis (MS) is a chronic inflammatory neurodegenerative disease with diverse symptomatology, significantly impacting patients’ quality of life (QoL). While pharmacological therapies focus primarily on reducing inflammation and relapse rates, non-pharmacological interventions, including digital health applications, have shown promise in improving QoL among persons with MS (PwMS). Pilot studies had shown the feasibility and acceptability of levidex, a digital health application based on cognitive behavioral therapy (CBT) principles, a broad set of behavior change techniques, and relevant lifestyle-change advice. This randomized controlled trial aimed to examine the effects of levidex on MS-related QoL over 6 months. Methods Participants who were diagnosed with MS for at least one year were recruited via the internet in Germany, using a secure survey software platform, and were randomly assigned to the intervention group (IG), in which they received standard care + levidex, or an active control group (CG), in which they received standard care and were offered web-adapted material on the topic of lifestyle change from the German Multiple Sclerosis Society (DMSG). The primary outcome was MS-related QoL after 6 months, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS); secondary outcomes included QoL subscales, sick days, and health behavior, among others. Analyses of Covariance (ANCOVA) were used to examine intervention effects at 6 months. Participants were recruited between November 2020 and February 2022. Results A total of 421 adult participants (mean age: 47.5, 78.1% women) were included and randomized (IG, n = 195, CG, n = 226). After 6 months, the IG exhibited significantly higher MS-related QoL, compared to the CG (total score HAQUAMS, adjusted group mean difference = -0.14, 95% CI: [-0.22, -0.06], p = 0.001; Cohen’s d = 0.23), with significant effects also observed on the cognitive and mood subscales. At 6 months, IG participants also reported significantly fewer sick days (median = 2 days in IG vs. 6 days in CG; W = 3939, p = 0.012) and significantly higher levels of daily activities, as measured by the Frenchay Activity Index, adjusted group mean difference = 1.37, 95% CI = [0.33, 2.40], p = 0.010; Cohen’s d = 0.16. Safety analyses showed no adverse events and good satisfaction. Conclusions Compared to the control group, levidex facilitated clinically relevant improvements in MS-related QoL, reduced sick days, and enhanced activity in PwMS over 6 months. These findings suggest that levidex can serve as an effective non-pharmacological adjunctive treatment element to standard care and could help improve QoL among PwMS. Trial registration Registered on 22.09.2020 at the German Clinical Trials Register DRKS00023023.

OBJECTIVE:Despite the availability of pharmacological treatment for seizures, people with epilepsy (PwE) commonly experience impairments in quality of life (QoL). Given the limited access to psychosocial treatments for PwE, digital interventions could bridge treatment gaps and help improve QoL. The objective of this study was to examine the effectiveness of emyna, a fully automated digital intervention based on cognitive behavioral therapy (CBT) techniques, in improving health-related QoL among PwE who reported impairments in QoL. A previous trial showed that emyna was effective in improving depressive symptoms among PwE with a comorbid depressive disorder, but its effects on QoL among PwE without comorbid depression remain unknown. METHODS:A pragmatic randomized controlled trial was conducted with N = 438 PwE (mean age = 37.5, 70.3% women, physician-verified diagnoses) who were assigned to the intervention group (n = 216), which used emyna alongside treatment as usual (TAU), or the control group (n = 222), which received TAU only. QoL and secondary outcomes such as general self-efficacy, medication adherence, general distress, and epilepsy-related work and social adjustment were assessed at baseline, 3 months, and 6 months. The primary outcome was QoL assessed with the Quality of Life in Epilepsy [QOLIE-31] total score at 3 months post-randomization. RESULTS:Findings from the intent-to-treat analyses showed that after 3 months, participants in the intervention group experienced significant and clinically relevant improvements in health-related QoL compared to the control group (baseline-adjusted group difference = 4.5; 95% CI = [2.0, 6.9], p < 0.001; Cohen's d = 0.32). Effects on secondary outcomes did not reach statistical significance. SIGNIFICANCE:This study extends previous research by demonstrating that emyna facilitates improvements in QoL in a diverse group of PwE treated in routine care settings. This CBT-based digital intervention therefore presents a convenient and cost-effective addition to healthcare providers' treatment repertoire. PLAIN LANGUAGE SUMMARY:In our study, we tested a digital program called emyna, which conveys cognitive behavioral therapy (CBT) techniques to help improve the quality of life for people living with epilepsy. We found that those who used emyna alongside their usual treatments felt better about their quality of life compared to those who did not use the program. Emyna offers a new, convenient way for people with epilepsy to manage their condition, which can be used alongside currently available treatments.

Web-based interventions can be effective in treating depressive symptoms. Patients with risk not responding to treatment have been identified by early change patterns. This study aims to examine whether early changes are superior to baseline parameters in predicting long-term outcome. In a randomized clinical trial with 409 individuals experiencing mild to moderate depressive symptoms using the web-based intervention deprexis, three latent classes were identified (early response after registration, early response after screening and early deterioration) based on early change in the first four weeks of the intervention. Baseline variables and these classes were included in a Stepwise Cox Proportional Hazard Multiple Regression to identify predictors associated with the onset of remission over 36-months. Early change class was a significant predictor of remission over 36 months. Compared to early deterioration after screening, both early response after registration and after screening were associated with a higher likelihood of remission. In sensitivity and secondary analyses, only change class consistently emerged as a predictor of long-term outcome. Early improvement in depression symptoms predicted long-term outcome and those showing early improvement had a higher likelihood of long-term remission. These findings suggest that early changes might be a robust predictor for long-term outcome beyond baseline parameters.

Abstract Background Many persons with multiple sclerosis (pwMS) desire to learn how health behaviour changes (e.g., dietary adjustments, physical activity, improvements in stress management) might help them manage their disease. Previous research has shown that certain health behaviour changes can improve quality of life (QoL), fatigue and other MS outcomes. Digital health applications may be well suited to deliver relevant health behavioural interventions because of their accessibility and flexibility. The digital health application “levidex” was designed to facilitate health behaviour change by offering evidence-based patient information and cognitive-behavioural therapy techniques to pwMS. By doing so, levidex aims to improve QoL and MS symptoms such as fatigue and mental health. Objectives A previous study reported on the development of levidex; this non-randomised pilot study examined the feasibility (practicability and acceptability) of levidex in pwMS with moderate to severe disability. Furthermore, the intervention’s impact on empowerment, stress management, and relevant health behaviours (e.g., dietary behaviour, physical activity) was explored. Methods levidex was originally developed for newly diagnosed pwMS in the first year after diagnosis and eventually modified to offer access to pwMS with moderate to severe disability. Participants (n = 43) with an Expanded Disability Status Scale between 3.5 and 7.5 and a disease duration of more than one year were eligible to participate. The intervention was used over a period of six months with measurement time points at baseline, month 3 and month 6. Results Out of 38 participants who completed the six-month intervention period, 18 (47.4%) completed all 16 modules and 9 (23.7%) reached modules 13–16, the long-term maintenance part of levidex. Participants rated levidex positively in terms of practicability and acceptability and had only few points of criticism such as to include more physical exercise routine suggestions suitable for participants with severe impairment. Data on secondary endpoints showed no significant changes. Conclusion This pilot study provided evidence for the practicability and acceptability of levidex, a digital health application designed to facilitate health behaviour change in pwMS with moderate to severe disability. Adequately powered randomised controlled studies with longer follow-up periods are needed to clarify the benefit of levidex in pwMS with moderate to severe disability. Trial registration German Clinical Trials Register (DRKS) DRKS00032667 (14/09/2023); Retrospectively registered.

BACKGROUND:Depression is three to four times more prevalent in patients with neurological and inflammatory disorders than in the general population. For example, in patients with multiple sclerosis, the 12-month prevalence of major depressive disorder is around 25% and it is associated with a lower quality of life, faster disease progression, and higher morbidity and mortality. Despite its clinical relevance, there are few treatment options for depression associated with multiple sclerosis and confirmatory trials are scarce. We aimed to evaluate the safety and efficacy of a multiple sclerosis-specific, internet-based cognitive behavioural therapy (iCBT) programme for the treatment of depressive symptoms associated with the disease. METHODS:This parallel-group, randomised, controlled, phase 3 trial of an iCBT programme to reduce depressive symptoms in patients with multiple sclerosis was carried out at five academic centres with large outpatient care units in Germany and the USA. Patients with a neurologist-confirmed diagnosis of multiple sclerosis and depressive symptoms were randomly assigned (1:1:1; automated assignment, concealed allocation, no stratification, no blocking) to receive treatment as usual plus one of two versions of the iCBT programme Amiria (stand-alone or therapist-guided) or to a control condition, in which participants received treatment as usual and were offered access to the iCBT programme after 6 months. Masking of participants to group assignment between active treatment and control was not possible, although raters were masked to group assignment. The predefined primary endpoint, which was analysed in the intention-to-treat population, was severity of depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) at week 12 after randomisation. This trial is registered at ClinicalTrials.gov, NCT02740361, and is complete. FINDINGS:Between May 3, 2017, and Nov 4, 2020, we screened 485 patients for eligibility. 279 participants were enrolled, of whom 101 were allocated to receive stand-alone iCBT, 85 to receive guided iCBT, and 93 to the control condition. The dropout rate at week 12 was 18% (50 participants). Both versions of the iCBT programme significantly reduced depressive symptoms compared with the control group (BDI-II between-group mean differences: control vs stand-alone iCBT 6·32 points [95% CI 3·37-9·27], p<0·0001, effect size d=0·97 [95% CI 0·64-1·30]; control vs guided iCBT 5·80 points [2·71-8·88], p<0·0001, effect size d=0·96 [0·62-1·30]). Clinically relevant worsening of depressive symptoms was observed in three participants in the control group, one in the stand-alone iCBT group, and none in the guided iCBT group. No occurrences of suicidality were observed during the trial and there were no deaths. INTERPRETATION:This trial provides evidence for the safety and efficacy of a multiple sclerosis-specific iCBT tool to reduce depressive symptoms in patients with the disease. This remote-access, scalable intervention increases the therapeutic options in this patient group and could help to overcome treatment barriers. FUNDING:National Multiple Sclerosis Society (USA).

Background: Breast cancer patients often experience low quality of life (QoL) during and after cancer treatment, which may influence disease progression and survival. Behavioural interventions, such as cognitive behavioural therapy (CBT), could potentially help improve QoL, but they are not always available or offered to these patients. Internet-based behavioural interventions could bridge such treatment gaps. In this set of studies, we investigated the effects of two novel CBT-based digital interventions ("optimune" and "lancivis"). Both of these digital interventions can be accessed via the Internet and engage patients in individually tailored "dialogues," in which personally relevant CBT techniques are conveyed.

Background:This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group. Methods:This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391. Findings:Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, p<0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's d=0·39). Interpretation:The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions. Funding:The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under grant agreement No. 689691.

Introduction Electronic health (eHealth) interventions integrate different elements of care in treating and preventing mental ill-health in patients with somatic illnesses. Identifying different sociodemographic characteristics that might be associated with higher perceived usability can help in improving the usability of these e-health interventions. Objectives This study aimed to identify sociodemographic characteristics that might be associated with the perceived usability of the NEVERMIND e-health system, comprised of a mobile application and a sensorized shirt, developed to reduce co-morbid depressive symptoms in patients with breast or prostate cancer. Methods The study included 129 patients with a diagnosis of breast or prostate cancer who received the NEVERMIND system. Sociodemographic data were collected at baseline. Usability outcomes included the System Usability Scale (SUS), the Mobile Application Rating Scale: user version (uMARS), and a usage index. Results The analysis was based on 108 patients (68 breast cancer and 40 prostate cancer patients) who used the NEVERMIND system. The overall mean SUS score at 12-weeks was 73.4 with no statistical differences among different sociodemographic characteristics. The global uMARS score was 3.8, and females scored the app higher than males (β coefficient= 0.16; p=.03, 95% CI 0.02 - 0.3). Females had significant lower usage (β coefficient= -0.13; p=.04, 95% CI -0.25 to -0.01) after adjusting for other covariates. Conclusions There was a higher favourability of the mobile application among females compared to males. However, males had significantly higher usage of the NEVERMIND system. The NEVERMIND system does not suffer from ‘digital divide’ where certain sociodemographic characteristics are more associated with higher usability. Disclosure No significant relationships.

IntroductionDespite the lack of high-quality evidence regarding its long-term effectiveness, intravenous corticosteroid therapy is recommended as the standard treatment of acute multiple sclerosis relapses in Germany. High financial expenses and the equivalent effectiveness of oral corticosteroid therapy contrast with this trend. There is an urgent need to provide patients with evidence-based and comprehensible information on relapse management and to actively involve patients in relapse treatment decisions. Web-based decision support on relapse management could be an effective measure to empower people with multiple sclerosis making informed treatment decisions.ObjectivesTo develop a web-based programme on relapse management for people with multiple sclerosis and evaluate the feasibility and acceptability of the intervention.MethodsThe study followed the first two phases of the UK Medical Research Council Framework for complex interventions. The first phase involved the development of an interactive web-based programme on relapse management. The second phase focused on the feasibility and pilot testing of the programme with people with multiple sclerosis and experts with a professional background in multiple sclerosis. Data was obtained using questionnaires with closed- and open-ended questions as well as qualitative semi-structured telephone interviews. Quantitative data was analyzed descriptively, whereas qualitative data was clustered by topic.ResultsFeasibility of the intervention programme was tested with 10 people with multiple sclerosis and 10 experts. Feasibility testing indicated good practicability and acceptance of the content. After revision, the programme was piloted with seven people with multiple sclerosis and three experts. The results showed good acceptance in both groups. Based on the feedback, a final revision was performed.ConclusionFeasibility and pilot testing indicated good user-friendliness, acceptance, and practicability of the programme. The programme is currently evaluated in a randomized controlled trial (Registration Number on ClinicalTrials.gov: NCT04233970). It is expected that the programme will have a positive impact on patients' relapse management and strengthen their autonomy and participation.

Background: A multiple sclerosis (MS) diagnosis urges decision-making on immunotherapies, while persons with MS (PwMS) need to develop a coping concept in parallel. At this stage, PwMS ask how they themselves may contribute to controlling the disease. Evidence suggests that maintaining a healthy lifestyle (e.g. physical activity and stress management) is a key factor for healthy aging and preserving activity, while data on MS are complex. Objectives: Following the Medical Research Council framework, this study aimed to develop and investigate the feasibility of a new digital health application that conveys evidence-based patient information about lifestyle factors in MS and engages PwMS in relevant behaviour change techniques. Methods: Based on a digital health application promoting lifestyle management in breast cancer survivors, an MS-specific adaptation ('levidex') was developed. Feasibility was tested with 15 PwMS and eight MS experts. Subsequently, a six-week pilot study with eight PwMS was conducted. All participants provided feedback on practicability and acceptability via a questionnaire and took part in a semi-structured telephone interview. Levidex was revised after each test phase. Results: The final levidex tool includes 16 modules, 177 references and several other functions. Feasibility results showed that PwMS and MS experts perceived levidex as understandable (14 out of 15; 6 out of 8), trustworthy (15 out of 15; 8 out of 8), and relevant (10 out of 15; 8 out of 8). Interviews revealed potential for improvement regarding the length and complexity of some content. Piloting of the revised version confirmed good feasibility and high acceptance. Most participants felt inspired to initiate (7 out of 8) or had already implemented (5 out of 8) lifestyle changes after working with levidex. Conclusion: Results suggest that levidex is feasible and well-accepted by PwMS and MS experts. It might be a useful tool to support PwMS in adapting to their diagnosis and initiating health-promoting lifestyle changes.

Abstract Specific psychological treatments for depressive disorders delivered on the Internet have shown effectiveness and presented advantages over face-to-face treatments (potentially less expensive, flexible schedules, available in remote areas). This paper aims to describe the characteristics of those who sought help from an online self-guided intervention for depression and to explore hypotheses about predictors of enrollment to the program. Based on a sample of 282 of individuals who filled in screening questionnaires, we verified that the respondents were mainly female, were on average 34.36 years old, were primarily recruited through Facebook, had been previously diagnosed by mental health professionals, presented moderate self-efficacy perception, and had moderately severe symptoms of depression. Respondents who reported comorbid conditions were more likely to attend enrollment interviews, and being in treatment or not did not influence attendance. Such characterization may provide strategies to reach more people and to optimize the design of interventions targeting help-seeking depressed individuals in Brazil.

BACKGROUND:Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom.METHODS:We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683.FINDINGS:We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components.INTERPRETATION:The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package.FUNDING:Japan Society for the Promotion of Science.

BACKGROUND Opioid use disorder (OUD) is characterized by the inability to control opioid use despite attempts to stop use and negative consequences to oneself and others. The burden of opioid misuse and OUD is a national crisis in the United States with substantial public health, social, and economic implications. Although medication-assisted treatment (MAT) has demonstrated efficacy in the management of OUD, access to effective counseling and psychosocial support is a limiting factor and a significant problem for many patients and physicians. Digital therapeutics are an innovative class of interventions that help prevent, manage, or treat diseases by delivering therapy using software programs. These applications can circumvent barriers to uptake, improve treatment adherence, and enable broad delivery of evidence-based management strategies to meet service gaps. However, few digital therapeutics specifically targeting OUD are available, and additional options are needed. OBJECTIVE To this end, we describe the development of the novel digital therapeutic MODIA. METHODS MODIA was developed by an international, multidisciplinary team that aims to provide effective, accessible, and sustainable management for patients with OUD. Although MODIA is aligned with principles of cognitive behavioral therapy, it was not designed to present any 1 specific treatment and uses a broad range of evidence-based behavior change techniques drawn from cognitive behavioral therapy, mindfulness, acceptance and commitment therapy, and motivational interviewing. RESULTS MODIA uses proprietary software that dynamically tailors content to the users’ responses. The MODIA program comprises 24 modules or “chats” that patients are instructed to work through independently. Patient responses dictate subsequent content, creating a “simulated dialogue” experience between the patient and program. MODIA also includes brief motivational text messages that are sent regularly to prompt patients to use the program and help them transfer therapeutic techniques into their daily routines. Thus, MODIA offers individuals with OUD a custom-tailored, interactive digital psychotherapy intervention that maximizes the personal relevance and emotional impact of the interaction. CONCLUSIONS As part of a clinician-supervised MAT program, MODIA will allow more patients to begin psychotherapy concurrently with opioid maintenance treatment. We expect access to MODIA will improve the OUD management experience and provide sustainable positive outcomes for patients.