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Usability and feasibility of a cognitive-behavioral mobile app for ADHD in adults [1]

['Laura E. Knouse', 'Department Of Psychology', 'University Of Richmond', 'Richmond', 'Virginia', 'United States Of America', 'Xiaodi Hu', 'Master Of Science In Human-Computer Interaction Program', 'College Of Information Studies', 'University Of Maryland']

Date: 2022-08 

Abstract Objective Cognitive-behavioral therapy (CBT) has growing evidence of efficacy for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. Mobile health apps are promising tools for delivering scalable CBT. In a 7-week open study of Inflow, a CBT-based mobile app, we assessed usability and feasibility to prepare for a randomized controlled trial (RCT). Method 240 adults recruited online completed baseline and usability assessments at 2 (n = 114), 4 (n = 97) and after 7 weeks (n = 95) of Inflow use. 93 participants self-reported ADHD symptoms and impairment at baseline and 7 weeks. Results Participants rated Inflow’s usability favorably, used the app a median of 3.86 times per week, and a majority of those using the app for 7 weeks self-reported decreases in ADHD symptoms and impairment. Conclusion Inflow demonstrated usability and feasibility among users. An RCT will determine whether Inflow is associated with improvement among more rigorously assessed users and beyond non-specific factors.

Author summary Attention-Deficit Hyperactivity Disorder (ADHD) is characterized by frequent and impairing inattention and/or hyperactivity/impulsivity that begins in childhood and sometimes continues to cause problems into adulthood. While some medications are helpful in treating ADHD, medications do not work for everyone and some adults continue to experience ADHD symptoms even with medication treatment. Cognitive-behavioral therapy (CBT) helps people learn skills to better manage their actions and thoughts. Face-to-face CBT for adult ADHD has shown promising results in some studies, but this treatment can be hard for people to access. Mobile apps are promising tools for delivering CBT to more people in their daily lives but only one previous study has examined a CBT-based app for adults with ADHD. To prepare for a larger controlled study, we gathered data from participants who used Inflow, a CBT-based mobile app, for 7 weeks. We recruited 240 adults online, gave them access to the app, and asked those who downloaded it (n = 205) to complete assessments after 2, 4, and 7 weeks. Participants rated Inflow as user-friendly and we learned more about how often people use they app and which features they access. A majority of the people who stayed in the study after 7 weeks (n = 93) rated their ADHD symptoms as less severe than when they started the study. Next, we need to conduct a randomized, controlled study to better evaluate whether these changes are really due to the effects of Inflow.

Citation: Knouse LE, Hu X, Sachs G, Isaacs S (2022) Usability and feasibility of a cognitive-behavioral mobile app for ADHD in adults. PLOS Digit Health 1(8): e0000083. https://doi.org/10.1371/journal.pdig.0000083 Editor: Laura M. König, University of Bayreuth: Universitat Bayreuth, GERMANY Received: February 4, 2022; Accepted: June 29, 2022; Published: August 15, 2022 Copyright: © 2022 Knouse et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: All relevant data can be accessed on Open Science Framework at https://osf.io/qa26m/. Funding: LK was supported by a University of Richmond School of Arts and Sciences Faculty Summer Research Fellowship during the completion of this work. This funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. GS and SI are co-founders of Inflow, the company that developed the app tested in this study, and they were supported by the company during their work on this project, which included collaboration on study design, data collection, and preparation of the manuscript. The company provided free access to the app for participants as part of the study. XH started a paid internship position with Inflow as a User Experience (UX) Research Intern on 13 June 2022 after the study was conducted and just prior to publication. All parties agreed to pursue publication of pre-registered analyses regardless of study outcome. Competing interests: We have read the journal’s policy and the authors of this manuscript have the following competing interests: LK is an unpaid clinical consultant and research collaborator with Inflow. She is also a member of the Professional Advisory Board of the non-profit Children and Adults with ADHD (CHADD). XH started a paid internship position with Inflow as a User Experience (UX) Research Intern on 13 June 2022 after the study was conducted and just prior to publication. GS and SI are co-founders of Inflow and have an ownership interest in the company. All parties agreed to pursue publication of pre-registered analyses regardless of study outcome.

Usability and feasibility of a cognitive-behavioral mobile app for ADHD in adults Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by frequent and impairing inattention and/or hyperactivity/impulsivity that begins in childhood but continues to cause problems into adulthood for about 2/3 of people diagnosed [1]. ADHD in adults is associated with functional impairment in a variety of domains including education, work, interpersonal relationships, and physical and mental health and well-being [2]. With an estimated prevalence of 4.4% in the U.S. population [3], ADHD in adulthood is associated with substantial individual and societal economic costs [4] and even reduced estimated life expectancy [5]. Stimulant medications have demonstrated efficacy in the treatment of adult ADHD [6,7]. However, these medications do not work for every adult with ADHD and even adults who experience a positive response to these medications may continue to experience clinically significant symptoms and impairment in need of intervention [8]. The most well-studied non-medication treatment approach for adult ADHD is cognitive behavioral therapy (CBT), which targets aspects of thoughts and behaviors that contribute to ADHD-related symptoms and impairment. CBT helps clients to develop and implement self-regulation skills and to manage thoughts that may impede their behavior change [9,10]. Importantly, to gain and sustain new skills, patients need to practice skills outside of CBT sessions and implement them in daily life [11,12]. Results from CBT-based treatments for adult ADHD have been promising in prior open trials and randomized controlled trials (RCTs), although available data remain somewhat limited [13–15]. For example, Safren and colleagues [16] found that a 12-session individual CBT program for adults with ADHD who had been treated with medication but who still experienced symptoms resulted in superior symptom reduction compared to a control treatment (relaxation training). Despite its potential efficacy, traditional CBT for adult ADHD has some disadvantages. First, traditional individual and group CBT has limited accessibility. These treatments often have a high barrier to entry, as they require clients to meet in person on a regular basis with a therapist, often in an on-site clinic, which can be inconvenient for people with certain disabilities or comorbid disorders [17]. Furthermore, access to therapists who are well trained in CBT for adult ADHD is limited and may not be available outside of urban centers. Second, traditional CBT for adult ADHD may have a high cost for clients, particularly in the United States healthcare system [18]. Finally, the skills taught in traditional CBT for ADHD can be challenging to implement in daily life, since treatment often takes place in an entirely different context (i.e., the clinic) from the settings in which skills will need to be implemented. For adults with ADHD, completing skills practice outside of sessions has been associated with greater benefit from CBT [19], yet following through with skills practice in daily life can be especially challenging for people with ADHD, given the executive functioning deficits associated with the disorder [20]. The increasing prevalence of mobile phone usage has paved the way for mobile health applications (mHealth apps), which may address some of the limitations of traditional therapy [21]. Some apps work in tandem with traditional CBT to better track patient’s symptoms and use of skills outside of therapy sessions: for example, CBT-I Coach enhances traditional CBT for insomnia [22,23]. Other apps are designed to be used independent of traditional CBT. Examples of this type include PRIME, an mHealth app designed to improve motivation and quality of life for young people with schizophrenia [24] and Zemedy, an mHealth app designed to increase access to CBT-based treatment for irritable bowel syndrome at scale [25]. Importantly, although data on the efficacy of self-contained CBT-based mHealth apps are currently limited, some promising findings are emerging. For example, in a randomized crossover trial, use of Zemedy was associated with significant reductions in IBS-related symptoms and depressive symptoms as well as improvements in quality of life [25]. A few studies have investigated the efficacy of internet-based CBT interventions for adult ADHD with promising results [26,27]. Recently, Jang and colleagues [28] reported positive usability and feasibility results for a chatbot-based app designed to provide psychoeducation and CBT self-help skills to adults with attention problems. In a small randomized controlled trial (n = 46) they found that, over four weeks, app users showed greater reductions in hyperactive-impulsive and overall ADHD symptoms than a group given an ADHD self-help book to read. This study suggests that apps promoting CBT-based ADHD psychoeducation and skills-based treatment may be a promising approach; however, to our knowledge, no other peer reviewed studies have investigated a CBT-based mHealth app specifically designed for adult ADHD. This represents a significant gap in the literature. A systematic review of available apps for ADHD identified 109 apps, 33 of which were designed for adults, but none of these reported or were supported by evidence of efficacy [29]. There is clearly a need for rigorous, systematic evaluations of app-based interventions for ADHD. The primary aim of the current study was to assess the usability and feasibility of Inflow, a novel mHealth app designed to deliver CBT for adult ADHD, toward the design of a randomized controlled trial. Importantly, Inflow is not a productivity tool such as a calendar or task list app; rather, it provides CBT-based psychoeducation and guides users in implementing new ADHD-relevant behavioral and cognitive skills in daily life. Inflow also allows clients to track their progress and access a supportive community of other users who are engaged with the app. We conducted a seven-week open feasibility study of Inflow. The primary aims of this preregistered study were to assess the usability and feasibility of the app for users. We hypothesized that the mean score on a usability scale at 2, 4, and 7 weeks would be greater than 3 (neither agree nor disagree) to a statistically significant degree, indicating positive experiences with app usability. We assessed feasibility via descriptive analysis of various aspects of users’ interactions with Inflow. We also collected participants’ self-reported data on ADHD symptoms and functioning to inform the design of a future RCT [30].

Discussion In this open feasibility study, Inflow demonstrated preliminary usability and feasibility among users with a self-identified need for a CBT-based app for adult ADHD. At all three time-points (2, 4, and after 7 weeks), users who remained in the study agreed that Inflow was user-friendly, helpful, and that they would recommend it to others. The median number of app sessions per week across users was 3.86 with a median duration of 3.40. The active use rate of Inflow was 3.43, meaning that the median participant actively interacted with Inflow materials, challenges, or other people in the community about 3–4 times per week. This rate of active use compares favorably with the active use rate of 2.3 obtained in the study of PRIME, the mHealth app for young people with schizophrenia [24] and is consistent with the favorable usability ratings. Participants who provided self-reported symptom and impairment data after 7 weeks of use, on average, experienced decreases in self-reported ADHD symptoms and functional impairment. Active engagement with Inflow components—not simply frequency and duration of app use—was associated with greater improvement in self-reported symptoms and impairment. A more rigorous RCT is clearly needed to further evaluate whether use of Inflow is associated with positive change above and beyond regression to the mean or non-specific factors and to further evaluate which components are most strongly associated with any treatment-related change. Our study joins the work of Jang and colleagues [28] in suggesting that mobile apps may be a feasible, user-friendly way of delivering psychoeducation and CBT skills to people with attention difficulties in daily life. Compared to participants who used their chatbot app over four weeks, we observed similar pre-to-post effect sizes for self-reported symptoms during our 7-week open trial. However, additional work is needed to establish the efficacy of CBT-based apps for adult ADHD. This study provided several pieces of important data toward the design of a follow-up RCT. We now have an estimate of the standard deviation and pre-to-post effect sizes of two key potential outcomes measures, the BAARS-IV and BFIS, to inform power analysis and sample size calculation for a future study. Findings from the current study will also aid in the selection of primary outcome measures in a future trial. While we looked to past work for our usability questionnaire [31], the scale we used was not validated and, in future work, we will plan to use a validated measure such as the mHealth App Usability Questionnaire [37]. Finally, we clearly need a more effective procedure to match participant survey data across time-points. We selected the unique identifier method to enhance confidentiality, but in the future we may use a consistent personal identifier such as email address to reduce the likelihood of mismatches. Reflecting on the current study also raised several additional issues that must be addressed in the design of a future RCT and these observations may also be useful to other researchers developing and testing mHealth apps designed to bring CBT into the daily lives of people with mental health disorders. Such studies present methodological challenges and require close collaboration between researchers from different disciplinary perspectives [38]. First, we must carefully consider the inclusion criteria for the study. In the current study, we did not require a self-reported ADHD diagnosis and yet we found that significant changes in symptoms and impairment during app use only occurred for the previously diagnosed group—a group with substantial self-reported symptoms and impairment. Although there are clear advantages to testing a very rigorously diagnosed clinical sample—using, for example, structured diagnostic interviews—such procedures might limit both the sample size and the generalizability of the study results, especially given the constraints of online recruitment. A recent RCT of Zemedy, the CBT-based app for irritable bowel syndrome, provides a potentially useful model in which the researchers used the results from multiple self-report scales to create a multi-part screening protocol [25]. Participant comorbidity is also important to consider in selecting inclusion criteria. Furthermore, the sample in the current study was majority White and more highly educated than the general U.S. population. A next-step study should recruit sufficient numbers of people with diverse racial and ethnic identities as well as people with more diverse education levels in order to adequately evaluate the efficacy of Inflow in these groups. Second, we must carefully consider which additional constructs should be assessed as primary or secondary outcome measures. In addition, the RCT should include a specific measure of potential harms or side effects of the intervention, given that CBT can be associated with adverse effects [18]. Finally, we will need to decide on the most appropriate comparison or control group for a future RCT and will need to employ more rigorous data analytic methods with reduced potential for bias, such as multiple imputation to handle missing data from drop outs. Importantly, multiple imputation will rely on the inclusion of additional baseline measures to use in imputing the missing data. As a feasibility study, the current work has a number of limitations, some of which are outlined in the preceding discussion of issues to address in a future RCT. One limitation not yet discussed is the dropout rates associated with mHealth app interventions. Of participants who consented, about 54% could be considered drop outs before the Week 7 assessment: 14% failed to successfully enroll with the Inflow app, 36% dropped out before Week 2, 3% between Week 2 and 4, and only 1% dropped out between Week 4 and 7. We anticipated a sizable dropout rate, despite our use of a potentially motivated recruitment pool, and took it into account when designing our recruitment plan and target sample size. Indeed, our dropout rate is not unexpected given the typically low retention rates for app use [39,40]. For example, in a recent survey, the global app retention rate after 30 days across all categories was 4.2% [40]. In past studies of app-based interventions for chronic disease, the average dropout rate was 43% [41]. Higher rates of dropout might also be related to the fully online recruitment procedures used in the current study (47% on average for fully online trials reported by Mathieu et al. [42])—another factor to consider in designing the subsequent RCT. Although not uncommon, high dropout rates are problematic for drawing conclusions from research. Drop out can be an indicator of a lack of feasibility of the intervention. Although we did not specify dropout rate, a priori, as a measure of feasibility, some dropouts may have occurred because participants did not find the app user-friendly and helpful, thereby positively biasing our usability and other findings. As such, it is important to emphasize that the findings are only representative of the participants who stayed in the study. We were encouraged to observe that dropout did not appear to be associated with baseline symptom severity, impairment, or comorbidity, and so we have no evidence that the app is less accessible to those participants most in need of it. Finally, high dropout may positively bias estimates of efficacy in a future randomized controlled trial. In addition to preventing dropout through the design of a future study and taking it into account in statistical analyses, future development of Inflow and other CBT-based apps will need to focus on continuing to boost participant engagement early in the user lifecycle [43]. And, while dropout during clinical trials is not a new problem, it is one that certainly reflects the “real world” of both traditional therapy and mHealth interventions [44]. Importantly, even when dropout rates are less favorable for app-based interventions than for traditional therapy, the accessibility of apps relative to traditional therapy could nonetheless result in delivering treatment to greater numbers of people in need. The current study reports the preliminary usability and feasibility of the Inflow app and paves the way for an RCT to better evaluate its effects on symptoms and impairment. We hope that this mHealth tool can increase access to the benefits of CBT for people with ADHD around the world.

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[1] Url: https://journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000083

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